Clinical trial · Interventional
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis
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 IN ASIAN SUBJECTS WITH MODERATE TO SEVERE 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 primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-690,550 | Drug | Tofacitinib | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo BID
- interventionNames
- Drug: placebo
- type
- EXPERIMENTAL
- label
- 5mg BID CP-690,550
- interventionNames
- Drug: CP-690,550
- type
- EXPERIMENTAL
- label
- 10mg BID CP-690,550
- interventionNames
- Drug: CP-690,550
Primary outcomes (2)
- measure
- Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to the first screening procedure.
* Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline (Day 1).
* Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).
Exclusion Criteria:
* Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed.
* Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
* Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study are excluded.References
Publications (1)
- DERIVEDZhang J, Tsai TF, Lee MG, Zheng M, Wang G, Jin H, Gu J, Li R, Liu Q, Chen J, Tu C, Qi C, Zhu H, Ports WC, Crook T. The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study. J Dermatol Sci. 2017 Oct;88(1):36-45. doi: 10.1016/j.jdermsci.2017.05.004. Epub 2017 May 16. PMID 28558978