A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309737
• Other study ID #: A3921079
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2011
• Last updated: September 18, 2014
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: September 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area

• A Psoriasis Area and Severity Index (PASI) score of 12 or greater

• Are considered to be candidates for systemic or light therapy

• Have no evidence of active or latent tuberculosis

Exclusion Criteria:

• Non-plaque or drug-induced forms of psoriasis

• Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)

• Any uncontrolled significant medical condition

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CP-690,550
10 mg oral BID, Continuous treatment for 52 Weeks
• CP-690,550
5 mg oral BID, Continuous treatment for 52 Weeks
• Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
• Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

Locations

Country	Name	City	State
Canada	CCA Medical Research Corporation	Ajax	Ontario
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Northwest Dermatology & Laser Centre	Calgary	Alberta
Canada	Co-Medica Research Network Inc.	Courtice	Ontario
Canada	Stratica Medical	Edmonton	Alberta
Canada	Eastern Canada Cutaneous Research Associates Ltd.	Halifax	Nova Scotia
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Siena Medical Research	Montreal	Quebec
Canada	Oshawa Clinic	Oshawa	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	NewLab Clinical Research Inc.	St. John's	Newfoundland and Labrador
Canada	Guildford Dermatology Specialists	Surrey	British Columbia
Canada	PerCuro Clinical Research Ltd	Victoria	British Columbia
Canada	Practice office of John D. Amiss MD	Victoria	British Columbia
Canada	K.Papp Clinical Research Inc.	Waterloo	Ontario
Canada	XLR8 Medical Research Inc.	Windsor	Ontario
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia
Germany	Facharzt fuer Dermatologie und Allergologie	Berlin
Germany	Klinische Forschung Berlin-Buch GmbH	Berlin
Germany	Dres.Kirsten Prepeneit und Volker Streit	Buchholz
Germany	Klinikum der Johann Wolfgang Goethe Universitaet	Frankfurt/Main
Germany	Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie	Halle
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter	Hanau
Germany	Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie	Luebeck
Germany	Hautarztpraxis Dres. Scholz, Sebastian, Schilling	Mahlow
Germany	Wilhelm Fresenius Klinik	Wiesbaden/ Bierstadt
Germany	Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin	Witten
Hungary	Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly	Szekszard
Hungary	Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly	Szombathely
Hungary	Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat	Veszprem
Mexico	Instituto Mexicano de Investigacion Clinica, S.A. de C.V	Mexico	D.f.
Mexico	Centro Medico San Lucas	Monterrey	Nuevo Leon
Mexico	Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio	Zapopan	Jalisco
Poland	Specjalistyczne Gabinety Lekarskie "Dermed?	Lodz
Poland	Klinika Dermatologii Wojskowy Instytut Medyczny	Warszawa
Poland	MTZ Clinical Research Sp. z o.o.	Warszawa
Puerto Rico	The Office of Dr. Alma M. Cruz, MD.	Carolina
Serbia	Military Medical Academy	Belgrade
Taiwan	Chang Gung Medical Foundation, Linkou Branch	Kwei-Shan	Taoyuan
Taiwan	Taipei Medical University-Shuang Ho Hospital	New Taipei City
Taiwan	Chang Gung Memorial Hospital Kaohsiung branch	Niao-Sung Hsiang	Kaohsiung County
Taiwan	Chung Shan Medical University Hospital	Taichung
Ukraine	MIHC Kharkiv City Dermatovenerologic Dispensary #2	Kharkiv
Ukraine	Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets	Kyiv
Ukraine	Lugansk Regional Dermatovenerologic Dispensary	Lugansk
Ukraine	Lviv regional municipal dermatovenerologic dispensary,	Lviv
Ukraine	Department of dermatology and venereology of Odessa National Medical University	Odessa
United States	Sherman Immediate Care Center (Imaging Only)	Algonquin	Illinois
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Austin Dermatology Associates	Austin	Texas
United States	Bakersfield Dermatology and Skin Cancer Medical Group	Bakersfield	California
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of North Carolina at Chapel Hill Hospital	Chapel Hill	North Carolina
United States	Radiant Research, Inc.	Columbus	Ohio
United States	Dermatology Treatment & Research Center, PA	Dallas	Texas
United States	InSight Diagnostic Center	Dallas	Texas
United States	Hudson Dermatology	Evansville	Indiana
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Bettencourt Skin Center	Henderson	Nevada
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Center for Clinical Studies	Houston	Texas
United States	Suzanne Bruce and Associates, PA	Houston	Texas
United States	North Florida Dermatology Associates, PA	Jacksonville	Florida
United States	University of California San Diego	La Jolla	California
United States	Dartmouth Hitchcock Medical Center - Section of Dermatology	Lebanon	New Hampshire
United States	Dermatology Research Associates	Los Angeles	California
United States	Expresscare Medical (X-Rays only)	Los Angeles	California
United States	Dermatologic Surgery Specialists, PC	Macon	Georgia
United States	University of Minnesota - Department of Dermatology	Minneapolis	Minnesota
United States	The Rockefeller University	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Health Concepts	Rapid City	South Dakota
United States	Saint Louis University - Department of Dermatology	Saint Louis	Missouri
United States	Office of Mark S. Lee, MD	San Antonio	Texas
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	MedDerm Associates	San Diego	California
United States	University of California San Diego	San Diego	California
United States	Schaumburg Dermatology	Schaumburg	Illinois
United States	NorthShore University HealthSystem - Division of Dermatology	Skokie	Illinois
United States	Central Dermatology, PC	St. Louis	Missouri
United States	Healthcare Partners Medical Group	Torrance	California
United States	Somerset Skin Centre - Dermcenter	Troy	Michigan
United States	Center for Clinical Studies	Webster	Texas
United States	Dundee Dermatology	West Dundee	Illinois
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  Germany,  Hungary,  Mexico,  Poland,  Puerto Rico,  Serbia,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).	Week 16
Primary	Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.	Week 16
Secondary	Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16	Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.	Baseline, Week 16
Secondary	Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.	Week 16
Secondary	Dermatology Life Quality Index (DLQI) Total Score	The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.	Baseline
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16	The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.	Baseline, Week 4,16
Secondary	Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).	Week 4
Secondary	Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.	Week 4
Secondary	Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.	Baseline, Week 16
Secondary	Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).	Week 52
Secondary	Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52	The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).	Week 52
Secondary	Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52	The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).	Week 52
Secondary	Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Baseline up to Week 16
Secondary	Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Baseline up to Week 16
Secondary	Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Baseline up to Week 16
Secondary	Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).	Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Secondary	Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Secondary	Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Secondary	Psoriasis Area and Severity Index (PASI) Score	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.	Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
Secondary	Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.	Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52
Secondary	Psoriasis Area and Severity Index (PASI) Component Scores	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 and where higher scores indicate greater severity of psoriatic lesions.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Secondary	Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 where higher scores indicate greater severity of psoriatic lesions.	Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52
Secondary	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.	Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52
Secondary	Total Body Surface Area (BSA) With Psoriasis	Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.	Baseline, Week 2, 4, 8,16, 20, 28, 40, 52
Secondary	Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Secondary	Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least a 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported.	Week 2, 4, 8,12,16, 20, 28, 40, 52
Secondary	Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response is reported.	Week 2, 4, 8,12,16, 20, 28, 40, 52
Secondary	Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked).	Week 2, 4, 8,12,16, 20, 28, 40, 52
Secondary	Nail Psoriasis Severity Index (NAPSI) Score	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.'n' signifies participants evaluable at specified time point for each arm.	Baseline, Week 8, 16, 20, 28, 40, 52
Secondary	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'n' signifies participants evaluable at specified time point for each arm.	Baseline,Week 8, 16, 20, 28, 40, 52
Secondary	Number of Affected Nails	Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number of psoriasis affected nails (presence of psoriatic manifestations on the nail matrix / nail bed) were assessed and reported. 'N' (number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.	Baseline, Week 8, 16, 20, 28, 40, 52
Secondary	Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'N' (number of participants analyzed) signifies participants with baseline nail psoriasis and who were unique in longitudinal model.	Baseline,Week 8,16, 20, 28, 40, 52
Secondary	Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.	Week 8, 16, 20, 28, 40, 52
Secondary	Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.	Week 8,16, 20, 28, 40, 52
Secondary	Itch Severity Item (ISI) Score	ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.	Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
Secondary	Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends.	Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52
Secondary	Dermatology Life Quality Index (DLQI) Score	The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.	Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52	The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Secondary	36-Item Short-Form Health Survey Version 2, Acute (SF-36)	36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).	Baseline, Week 16, 28, 52
Secondary	Hospital Anxiety and Depression Scale (HADS) Score	HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale and 7 items comprising the depression subscale. Each item has response options ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total HADS score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Baseline, Week 8, 16, 28, 52
Secondary	Work Limitation Questionnaire (WLQ) Index Score	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands Scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).	Baseline, Week 8, 16, 28, 52
Secondary	Percentage of Participants With Patient Global Assessment (PtGA) Scale Response	The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).	Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
Secondary	Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response	The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study treatment.	Week 16, 28, 52
Secondary	Joint Pain Assessment (JPA) Score	The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain".	Baseline, Week 8,16, 28, 52
Secondary	Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 16, 28, 40, 52
Secondary	Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.	Baseline,Week 16, 28, 40, 52
Secondary	Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist and Rheumatologist. Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.	Baseline, Week 16
Secondary	Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants (currently employed [Emp]) answered (Yes/No [Y/N]): "Were you absent or on sick leave from work due to psoriasis today?", and participants (unemployed [UEmp]) answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.	Baseline, Week 16
Secondary	Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.	Week 16
Secondary	Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.	Baseline, Week 16
Secondary	Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.	Baseline, Week 16
Secondary	Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work	The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means "ability to work was not affected by psoriasis", and 10 means "ability to work was completely affected by psoriasis". Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.	Baseline, Week 16
Secondary	Family Dermatology Life Quality Index (FDLQI) Score	The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.	Baseline, Week 16, 52

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