Tofacitinib Ointment For Chronic Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase 2b, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Efficacy, Safety, Local Tolerability And Pharmacokinetics Of 2 Dose Strengths And 2 Regimens Of Tofacitinib Ointment In Subjects With Chronic Plaque Psoriasis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831466
• Other study ID #: A3921082
• Secondary ID: 2012-005645-20
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2013
• Last updated: October 26, 2015
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline

• At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails)

• If received certain treatments, should be off treatment for a minimum period of time (washout)

Exclusion Criteria:

• Currently have non-plaque forms of psoriasis or drug-induced psoriasis

• Require treatment with or cannot stop medication(s) prohibited during the study

• Have certain laboratory abnormalities at Baseline

• Current or history of certain infections

• Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
• tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
• placebo ointment (vehicle)
placebo ointment (vehicle) BID (twice daily) for 12 weeks
• tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
• tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
• placebo ointment (vehicle)
placebo ointment (vehicle) QD (once daily) for 12 weeks

Locations

Country	Name	City	State
Canada	CCA Medical Research Corporation	Ajax	Ontario
Canada	Ultranova Skincare	Barrie	Ontario
Canada	Stratica Medical	Edmonton	Alberta
Canada	Dermatrials Research	Hamilton	Ontario
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Innovaderm Research Inc	Montreal	Quebec
Canada	Siena Medical Research	Montreal	Quebec
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	K. Papp Clinical Research Inc.	Waterloo	Ontario
Canada	XLR8 Medical Research	Windsor	Ontario
Canada	Dermadvances Research	Winnipeg	Manitoba
Denmark	Dermatologisk Afdeling S	Aarhus C
Denmark	Hudklinikken Herning	Herning
Poland	NZOZ Centrum Osteoporozy i Chorob Kostno-Stawowych J. Badurski Spolka Jawna	Bialystok
Poland	Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik	Bialystok
Poland	Pomorskie Centrum Traumatologii im.Mikolaja Kopernika w Gdansku Oddzial Dermatologii	Gdansk
Poland	Krakowskie Centrum Medyczne Sp. z o.o.	Krakow
Poland	Maxxmed Centrum Zdrowia i Urody	Lublin
Poland	Gabinet Lekarski RTG USG Dr n. med. Pawel Skrzywanek; Pracownia Radiologiczna	Poznan
Poland	NZOZ Solumed	Poznan	Wielkopolskie
Poland	High-Med. Przychodnia Specjalistyczna	Warszawa
Poland	Klinika Ambroziak ESTEDERM Sp. z o.o.SKA	Warszawa	Mazowieckie
Poland	Wojskowy Instytut Medyczny	Warszawa 44
Poland	NZOZ multiMedica	Wroclaw
United States	Atlanta Dermatology, Vein & Research Center	Alpharetta	Georgia
United States	Arlington Research Center Inc.	Arlington	Texas
United States	Advanced Medical Research, Inc	Atlanta	Georgia
United States	Bakersfield Dermatology and Skin Cancer Medical Center	Bakersfield	California
United States	Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Suzanne Bruce and Associates, PA	Houston	Texas
United States	UC Irvine Dermatology Research	Irvine	California
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Dermatology Research Associates	Los Angeles	California
United States	Dermatology Research Associates	Nashville	Tennessee
United States	MedaPhase Inc.	Newnan	Georgia
United States	Park Avenue Dermatology, PA	Orange Park	Florida
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center, PC	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Health Concepts	Rapid City	South Dakota
United States	Lee Medical Associates	San Antonio	Texas
United States	Progressive Clinical Research	San Antonio	Texas
United States	Olympian Clinical Research	Tampa	Florida
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,  Denmark,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (=) 2 Grade/Point Improvement From Baseline at Week 12	Clinical signs of plaque psoriasis (erythema [E], induration [I], and scaling [S]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.	Baseline, Week 12	No
Primary	Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and =2 Grade/Point Improvement From Baseline at Week 8	Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.	Baseline, Week 8	No
Secondary	Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12	Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.	Week 12	No
Secondary	Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8	Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.	Week 8	No
Secondary	Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and =2 Grade/Point Improvement From Baseline at Week 12	Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.	Baseline, Week 12	No
Secondary	Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and =2 Grade/Point Improvement From Baseline at Week 8	Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.	Baseline, Week 8	No
Secondary	Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.	Baseline, Week 12	No
Secondary	Percent Change From Baseline to Week 8 in PASI	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.	Baseline, Week 8	No
Secondary	Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.	Baseline, Week 12	No
Secondary	Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.	Baseline, Week 8	No
Secondary	Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis	Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.	Baseline, Week 12	No
Secondary	Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis	Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.	Baseline, Week 8	No
Secondary	Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores	The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their "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. Participants completed the ISI assessments at the clinic (i.e., clinic-based).	Baseline, Week 12	No
Secondary	Change From Baseline to Week 8 in Clinic-Based ISI Scores	The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their "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. Participants completed the ISI assessments at the clinic (i.e., clinic-based).	Baseline, Week 8	No
Secondary	Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score	DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant 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, Week 12	No
Secondary	Change From Baseline to Week 8 in the DLQI Total Score	DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant 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, Week 8	No
Secondary	Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and =2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score =2 at Baseline	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, Week 12	No
Secondary	Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and =2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score =2 at Baseline	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, Week 8	No

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