Clinical trial · Interventional
Tofacitinib Ointment For Chronic Plaque Psoriasis
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriasis | — | UNRESOLVED | — |
| Psoriasis Vulgaris | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo ointment (vehicle) | Drug | — | UNRESOLVED |
| tofacitinib ointment 10 mg/g | Drug | — | UNRESOLVED |
| tofacitinib ointment 20 mg/g | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Treatment Group A
- interventionNames
- Drug: tofacitinib ointment 20 mg/g
- type
- EXPERIMENTAL
- label
- Treatment Group B
- interventionNames
- Drug: tofacitinib ointment 10 mg/g
- type
- PLACEBO_COMPARATOR
- label
- Treatment Group C
- interventionNames
- Drug: placebo ointment (vehicle)
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPapp 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. PMID 27716172