Phase 2 N=471 Randomized Quadruple-blind Treatment

Tofacitinib Ointment For Chronic Plaque Psoriasis

Psoriasis Vulgaris · Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT01831466 ↗

Enrolled (actual)

471

Serious AEs

2.3%

Results posted

Nov 2015

Primary outcome: 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 — 21.1; 12.9; 16.9; 20.0 Percentage of Participants — p=0.5425

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: tofacitinib ointment 20 mg/g (Drug); tofacitinib ointment 10 mg/g (Drug); placebo ointment (vehicle) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
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	21.1; 12.9; 16.9; 20.0; 21.6; 17.6	0.5425
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	22.5; 10.0; 11.3; 18.6; 14.9; 8.1	0.0710
SECONDARY Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12	33.8; 25.7; 23.9; 27.1; 29.7; 23.0	—
SECONDARY Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8	36.6; 20.0; 22.5; 32.9; 21.6; 12.2	—
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	18.3; 11.4; 14.1; 15.7; 18.9; 12.2	—
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	21.1; 7.1; 11.3; 15.7; 9.5; 4.1	—
SECONDARY Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)	-36.6; -35.7; -32.0; -38.6; -31.4; -30.0	—
SECONDARY Percent Change From Baseline to Week 8 in PASI	-36.7; -29.1; -28.8; -36.5; -29.0; -27.1	—
SECONDARY Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12	16.9; 12.9; 12.7; 15.7; 10.8; 6.8	—
SECONDARY Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8	14.1; 8.6; 7.0; 15.7; 6.8; 6.8	—
SECONDARY Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis	-32.8; -27.5; -27.7; -24.6; -15.6; -11.2	—
SECONDARY Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis	-25.4; -22.5; -20.5; -17.8; -9.0; -11.7	—
SECONDARY Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores	-2.88; -2.89; -1.73; -2.38; -1.94; -1.50	—
SECONDARY Change From Baseline to Week 8 in Clinic-Based ISI Scores	-3.07; -2.38; -1.45; -2.49; -1.91; -1.34	—
SECONDARY Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score	-4.6; -3.2; -2.6; -5.6; -3.3; -2.3	—
SECONDARY Change From Baseline to Week 8 in the DLQI Total Score	-4.6; -2.6; -2.8; -5.0; -2.7; -2.2	—
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	8.8; 17.5; 7.3; 13.2; 14.5; 7.7	—
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	5.0; 6.3; 10.9; 10.0; 6.0; 1.7	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01831466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.