A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects 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 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241591
• Other study ID #: A3921080
• Status: Completed
• Phase: Phase 3
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: December 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1101
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);

• Have plaque-type psoriasis covering at least 10% of total body surface area

• Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria:

• Non-plaque or drug induced forms of psoriasis

• Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis

• Cannot discontinue phototherapy

• Any uncontrolled significant medical condition

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CP 690,550 5 mg
CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
• CP 690,550 10 mg
CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks

Biological:
• Etanercept 50 mg
Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks

Other:
• Placebo
Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Dermatologicas	Ciudad Autonoma de Buenos Aires	C1114aap
Argentina	Centro de Investigaciones Dermatologicas	Ciudad Autonoma de Buenos Aires
Argentina	IMAI (Instituto Medico de Asistencia e Investigaciones)	Ciudad Autonoma de Buenos Aires
Austria	LKH Feldkirch Abteilung fuer Dermatologie und Venerologie	Feldkirch
Austria	LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie	Innsbruck
Austria	LKH Salzburg, Landesklinik fuer Dermatologie	Salzburg
Austria	Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel	Wien
Belgium	Cliniques universitaires Saint-Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Bosnia and Herzegovina	Department for skin and venerial diseases, Clinical Center University of Sarajevo	Sarajevo
Bulgaria	Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven	Pleven
Bulgaria	MBAL na Voennomeditsinska akademia- Sofia	Sofia
Bulgaria	Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia	Sofia
Bulgaria	Tsentar za kozhno-venericheski zaboliavania" EOOD	Sofia
Bulgaria	Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia	Sofia
Chile	Clinica Dermovein S.A.	Santiago
Chile	Hospital Clinico Universidad de Chile, Departamento Dermatologia	Santiago
Chile	Clinica Davila	Santiago, Rm 8431657	RM
Chile	Centro de Especialidades Dermatologicas	Vina del Mar	V Region
Colombia	Centro Integral de Reumatología del Caribe Circaribe S.A	Barranquilla	Atlantico
Colombia	Centro de Investigacion Clinica de la Universidad del Rosario	Bogota	Cundinamarca
Colombia	Riesgo de Fractura S.A.	Bogota	Cundinamarca
Colombia	Medicity S.A.S	Bucaramanga	Santander
Colombia	Reumalab S.A.S.	Medellin	Antioquia
Croatia	Department of Dermatovenerology, University Hospital Center Osijek	Osijek
Croatia	Department of dermatovenerology, University Hospital Center Zagreb	Zagreb
Croatia	Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"	Zagreb
Czechia	Nemocnice Ceske Budejovice, a.s.	Ceske Budejovice
Czechia	FN Kradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Plzen	Plzen - Bory
Czechia	Kozni ordinace	Praha 1
Czechia	Kralska zdravotni	Usti nad Labem
Czechia	Kralska zdravotni a.s., Masarykovy nemocnice o.z.	Usti nad Labem
Denmark	Department of Dermatology, Aarhus University Hospital	Aarhus C
Denmark	Bispebjerg Hospital, University of Copenhagen	Copenhagen NV
Denmark	Hudklinikken Herning	Herning
France	CHU de Besancon - Hopital Saint Jacques	Besancon
France	Hopital Ambroise Pare, Service de Dermatologie	Boulogne
France	Chu Morvan	BREST Cédex
France	CHG Le Mans	Le Mans	Cedex 09
France	Hopital Dupuytren	Limoges
France	Hopital Fournier	NANCY Cédex
France	CHU de Nantes - Hotel Dieu	Nantes Cedex 1
France	CHU de NICE - Hôpital de l'Archet II	Nice
France	Hôpital Bichat	Paris
France	Hopital Saint-Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Benite
France	C.H.U. de Poitiers	Poitiers
France	Hopital Robert Debre	Reims
France	Hopital Nord	Saint Priest En Jarez
France	Hôpital Larrey	Toulouse cedex 9
France	Hôpital de Brabois / Bâtiment Philippe Canton	Vandoeuvre-les-Nancy
Germany	Charite - Universitaetsmedizin Berlin	Berlin
Germany	Hautarztpraxis	Berlin
Germany	Dres.Kirsten Prepeneit und Volker Streit	Buchholz
Germany	Universitaetsklinik Carl Gustav Carus	Dresden
Germany	Hautzentrum Duelmen	Duelmen
Germany	Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum	Erlangen
Germany	Klinikum der Johann Wolfgang Goethe Universitaet	Frankfurt/Main
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Hautklinik der Ruprecht-Karls-Universitaet Heidelberg	Heidelberg
Germany	Universitaets- Hautklinik Koeln	Koeln
Germany	Hautarztpraxis Dres. Scholz, Sebastian, Schilling	Mahlow
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR	Mainz
Germany	Technische Universitaet Muenchen	Muenchen
Germany	Dres. med. Bredlich/PD Rosenbach/Thiele	Osnabrueck
Germany	Eberhard-Karls-Universitaet Tuebingen	Tuebingen
Germany	Hautarztpraxis	Witten
Hong Kong	The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)	Hong Kong
Hungary	Synexus Magyarorszag Kft.	Budapest
Hungary	Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika	Debrecen
Hungary	Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat	Miskolc
Hungary	SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika	Szeged
Hungary	ALLERGO-DERM BAKOS Kft.	Szolnok
Israel	Dermatology Department	Afula
Korea, Republic of	Samsung Medical Center / Department of Dermatology	Gangnam-Gu	Seoul
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine/Department of Dermatology	Seoul
Netherlands	Academic Medical Centre (AMC)	Amsterdam	Noord Holland
Netherlands	PT & R	Beek
Netherlands	Amphia Hospital Location Molengracht / Department Dermatology	Breda
Netherlands	Erasmus MC	Rotterdam
Poland	NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok
Poland	Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Krakowskie Centrum Medyczne NZOZ	Krakow
Poland	Novum Instytut Dermatologii Leczniczej i Estetycznej	Opole
Poland	Solumed S.C.	Poznan
Russian Federation	Korolev Dermatovenerologic Dispensary	Korolev	Moscow Region
Russian Federation	Dermatovenerologic dispensary #7	Moscow
Russian Federation	State Research Center of Dermatovenerology, Department of clinical dermatology	Moscow
Russian Federation	State Research Center of Dermatovenerology, Department of dermatology	Moscow
Russian Federation	Rostov-on-Don regional dermatovenerologic dispensary	Rostov-on-Don
Russian Federation	Ryazan regional clinical dermatovenerologic dispensary	Ryazan
Russian Federation	Dermatovenerologic dispensary #10 of Vyborg region	Saint-Petersburg
Russian Federation	Military medical academy S.M. Kirov	Saint-Petersburg
Russian Federation	North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department	Saint-Petersburg
Russian Federation	Clinic of dermatovenerologic diseases	Saratov
Russian Federation	Smolensk State Medical Academy	Smolensk
Russian Federation	Clinical hospital of emergency care N.V. Soloviev	Yaroslavl
Singapore	Changi General Hospital	Singapore
Singapore	National Skin Centre	Singapore
Slovakia	Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta	Banska Bystrica
Slovakia	Narodny ustav reumatickych chorob	Piestany
Slovakia	DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.	Svidnik
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcon	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Sweden	Falu lasarett, Hudkliniken	Falun
Sweden	Hermelinen Forskning AB	Lulea
Sweden	Skanes Universitetssjukhus i Malmo, Hudkliniken	Malmo
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm
Sweden	Sodersjukhuset, Hudkliniken	Stockholm
Switzerland	Kantonsspital St. Gallen	St. Gallen
Turkey	Mersin University Medical Faculty	Akdeniz	Mersin
Turkey	Gazi University Medical Faculty	Besevler	Ankara
Turkey	Istanbul university Istanbul Medical Faculty	Capa	Istanbul
Turkey	Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali	Izmir
Turkey	T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali	Pendik	Istanbul
United Kingdom	Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology	Leicester
United Kingdom	Whipps Cross University Hospital	London	Leytonstone

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12	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 to 4). The severity scores are summed and averaged after which the total average is 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 12
Primary	Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12	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. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.	Week 12
Secondary	Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment	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 to 4). The severity scores are summed and averaged after which the total average is 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 is defined as 0 (clear) or 1 (almost clear).	Weeks 2, 4, and 8
Secondary	Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment	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 to 4). The severity scores are summed and averaged after which the total average is 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).	Baseline and Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment	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. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.	Weeks 2, 4, and 8
Secondary	Mean PASI Score During the 12-Week Double-Blind Treatment	Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.	Baseline and Weeks 2, 4, 8, and 12
Secondary	Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment	Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.	Weeks 2, 4, 8, and 12
Secondary	Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment	Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.	Baseline and Weeks 2, 4, 8, and 12
Secondary	Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment	Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.	Weeks 2, 4, 8, and 12
Secondary	Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment	Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area 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. 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.	Baseline and Weeks 2, 4, 8, and 12
Secondary	Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment	Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area 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. 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.	Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment	PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.	Weeks 2, 4, 8, and 12
Secondary	Median Time to PASI50 Response During the 12-Week Double-Blind Treatment		Baseline up to Week 12
Secondary	Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment	PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.	Weeks 2, 4, 8, and 12
Secondary	Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment		Baseline up to Week 12
Secondary	Percentage of Participants With a PASI Score Greater Than or Equal to (=)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment		Weeks 2, 4, 8, and 12
Secondary	Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment	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, Weeks 2, 4, 8, and 12
Secondary	Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment	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.	Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment	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.	Weeks 2, 4, 8, and 12
Secondary	Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment	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 questions are rated by the participant as 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 and Weeks 4 and 12
Secondary	Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment	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 questions are rated by the participant as 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. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.	Weeks 4 and 12
Secondary	Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment	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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).	Baseline and Weeks 4 and 12
Secondary	Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment	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 questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.	Weeks 4 and 12
Secondary	Percentage of Participants Achieving DLQI Response =5 During the 12-Week Double-Blind Treatment	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 questions are rated by the participant as 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.	Weeks 4 and 12
Secondary	Percentage of Participants Achieving DLQI Response =1 During the 12-Week Double-Blind Treatment	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 questions are rated by the participant as 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.	Weeks 4 and 12
Secondary	Median Time to DLQI Response	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 questions are rated by the participant as 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. DLQI Response was defined as a 5-point reduction in the total DLQI score.	Weeks 4 and 12
Secondary	Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12	The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.	Baseline and Week 12
Secondary	Mean SF-36 Domain Scores at Baseline and Week 12	The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.	Baseline and Week 12
Secondary	Mean Change From Baseline in SF-36 MCS and PCS Scores	The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.	Week 12
Secondary	Mean Change From Baseline in SF-36 Domain Scores	The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.	Week 12
Secondary	Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment	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; 1=almost clear; 2=mild; 3=moderate; 4=severe).	Baseline and Weeks 2, 4, and 8
Secondary	Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment	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; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.	Weeks 2, 4, 8, and 12
Secondary	Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment	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 medication.	Week 12
Secondary	Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12	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 medication.	Week 12
Secondary	Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment	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 and Week 12
Secondary	Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment	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.	Week 12
Secondary	Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment	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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.	Baseline and Week 12
Secondary	Mean Change From Baseline in EQ-5D VAS at Week 12	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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.	Week 12
Secondary	Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment	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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").	Baseline and Week 12
Secondary	Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12	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 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").	Week 12
Secondary	Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment	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 [GPs], primary care physicians [PCPs], or family medicine physicians [FMP], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.	Baseline (BL) and Week 12
Secondary	Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment		Week 12
Secondary	Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work	Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.	Baseline and Week 12
Secondary	Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment	Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.	Week 12
Secondary	Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment	The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.	Baseline and Week 12
Secondary	Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment	The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.	Week 12

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