A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12
Study Overview
Brief Summary
The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have been diagnosed with plaque psoriasis for at least 6 months.
- •Have plaque psoriasis covering at least 15% of their total body.
- •Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
- •Be willing and able to comply with scheduled visits, treatment plan and other study procedures.
Exclusion Criteria
- •Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
- •Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
- •Subject is participating in another trial using an investigational agent or procedure.
- •Women who are pregnant or breast-feeding or considering becoming pregnant.
Arms & Interventions
4
Intervention: Placebo (Drug)
1
Intervention: CP-690,550 (Drug)
2
Intervention: CP-690,550 (Drug)
3
Intervention: CP-690,550 (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12
Time Frame: Week 12
Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Secondary Outcomes
- Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"(Week 2, 4, 8, 12, 14, 16)
- Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score(Week 2, 4, 8, 14, 16)
- Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score(Week 2, 4, 8, 12, 14, 16)
- Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score(Week 12)
- Psoriasis Area and Severity Index (PASI) Component Scores and Total Score(Baseline, Week 2, 4, 8, 12, 14, 16)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16(Baseline, Week 2, 4, 8, 12, 14, 16)