Phase 2
N=81
Topical CP-690,550 For Chronic Plaque Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00678561 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 — 2.38; -4.76; 2.48; -4.17 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CP-690,550 (Drug); Placebo Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 |
2.38; -4.76; 2.48; -4.17; -4.46; -1.77 | — |
| SECONDARY Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions |
0.0; 0.0; 0.0; 0.0; 6.7; 0.0 | — |
| SECONDARY Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 |
0.00; 5.56; -1.39; -16.67; -1.59; 4.24 | — |
| SECONDARY Number of Participants With Administration Site Adverse Events |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Drug Plasma Concentrations of CP-690,555 |
0.183; 0.116; NA; 0.174; NA; 0.126 | — |
| SECONDARY Skin Biopsy Drug Concentrations |
3.4145; 2.2320; 0.3242; 0; 8.2810; 0.2957 | — |
Summary
Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.
Eligibility Criteria
Inclusion Criteria
- Having chronic plaque psoriasis for at least 6 months
- Able to withdraw all prior psoriasis treatments
- Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study
Exclusion Criteria
- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
- Pregnant or lactating women
- Unwilling to use appropriate contraceptive methods
Data sourced from ClinicalTrials.gov (NCT00678561). 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.