Clinical trial NCT01831466: Tofacitinib Ointment For Chronic Plaque Psoriasis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Psoriasis
Keywords: plaque psoriasis
vulgaris
topical treatment
skin diseases
papulosquamous
Tofacitinib
CP-690550
Xeljanz
psoriasis
moderate
severe
itch
nail psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8
timeFrame: Week 8
measure: 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
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline, Week 8
measure: Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline to Week 8 in PASI
timeFrame: Baseline, Week 8
measure: Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8
timeFrame: Baseline, Week 8
measure: Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis
timeFrame: Baseline, Week 8
measure: Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 8 in Clinic-Based ISI Scores
timeFrame: Baseline, Week 8
measure: Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 8 in the DLQI Total Score
timeFrame: Baseline, Week 8
measure: 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
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Center
state: California
city: Irvine
country: United States
facility: UC Irvine Dermatology Research
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center
state: Georgia
city: Atlanta
country: United States
facility: Advanced Medical Research, Inc
state: Georgia
city: Newnan
country: United States
facility: MedaPhase Inc.
state: Georgia
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
state: Massachusetts
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center Inc.
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Lee Medical Associates
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Winnipeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
state: Ontario
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: Aarhus C
country: Denmark
facility: Dermatologisk Afdeling S
city: Herning
country: Denmark
facility: Hudklinikken Herning
city: Warszawa
country: Poland
facility: Klinika Ambroziak ESTEDERM Sp. z o.o.SKA
state: Mazowieckie
city: Poznan
country: Poland
facility: NZOZ Solumed
state: Wielkopolskie
city: Bialystok
country: Poland
facility: Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
city: Bialystok
country: Poland
facility: NZOZ Centrum Osteoporozy i Chorob Kostno-Stawowych J. Badurski Spolka Jawna
city: Gdansk
country: Poland
facility: Pomorskie Centrum Traumatologii im.Mikolaja Kopernika w Gdansku Oddzial Dermatologii
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Lublin
country: Poland
facility: Maxxmed Centrum Zdrowia i Urody
city: Poznan
country: Poland
facility: Gabinet Lekarski RTG USG Dr n. med. Pawel Skrzywanek; Pracownia Radiologiczna
city: Warszawa 44
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warszawa
country: Poland
facility: High-Med. Przychodnia Specjalistyczna
city: Wroclaw
country: Poland
facility: NZOZ multiMedica
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Papp KA, Bissonnette R, Gooderham M, Feldman SR, Iversen L, Soung J, Draelos Z, Mamolo C, Purohit V, Wang C, Ports WC. Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial. BMC Dermatol. 2016 Oct 3;16(1):15. doi: 10.1186/s12895-016-0051-4.