Phase 2
N=197
Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00678210 ↗Enrolled (actual)
197
Serious AEs
1.5%
Results posted
Dec 2012
Primary outcome: Primary: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 — 25.00; 40.82; 66.67; 2.00 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CP-690,550 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 |
25.00; 40.82; 66.67; 2.00 | — |
| SECONDARY Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" |
8.33; 12.50; 16.67; 4.08; 18.37; 28.57 | — |
| SECONDARY Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score |
0.00; 2.08; 2.08; 0.00; 8.33; 14.29 | — |
| SECONDARY Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score |
10.64; 14.58; 25.00; 0.00; 29.17; 44.90 | — |
| SECONDARY Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score |
14.58; 18.37; 33.33; 0.00 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Component Scores and Total Score |
2.1; 2.1; 2.4; 2.4; 2.8; 2.7 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16 |
-0.4; -0.7; -1.0; -0.2; -0.6; -0.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00678210). 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.