Clinical trial · Interventional
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
A Phase 3, Multi Site, Randomized, Double Blind Study Of The Long-term Safety, Tolerability And Efficacy Of 2 Oral Doses Of Cp 690,550 In Subjects With Moderate To Severe Plaque Psoriasis And/or Psoriatic Arthritis
- 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 main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-690,550 | Drug | Tofacitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CP-690,550 10 mg BID
- interventionNames
- Drug: CP-690,550
- type
- EXPERIMENTAL
- label
- CP690,550 5 mg BID
- interventionNames
- Drug: CP-690, 550
Primary outcomes (5)
- measure
- Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
- timeFrame
- Week 16
- description
- The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Are 20 years or older and considered to be candidates for systemic or phototherapy. \[Moderate to Severe Plaque Psoriasis\] * Diagnosed for at least 12 months. * Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA). \[Psoriatic Arthritis\] * Diagnosed for at least 6 months. * Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening; * Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter. Exclusion Criteria: * Non-plaque or drug induced forms of psoriasis * Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB) * any uncontrolled significant medical condition
References
Publications (0)
Data not yet available