Phase 2
N=12
Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01710046 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Apr 2015
Primary outcome: Primary: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 — 62.50; 33.33 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- (CP-6890,550) Tofacitinib (Drug); Placebo (Drug); (CP-690,550) Tofacitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 |
62.50; 33.33 | — |
| PRIMARY Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 |
50.00; 33.33 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Score by Visit |
21.91; 23.33; 17.81; 15.53; 13.84; 13.13 | — |
| SECONDARY Change From Baseline in PASI by Visit |
— | — |
| SECONDARY Percent Change From Baseline in PASI by Visit |
-18.38; -39.61; -36.95; -48.66; -47.39; -49.66 | — |
| SECONDARY Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4 |
0.00; 0.00; 0.00; 33.33; 22.22; 33.33 | — |
| SECONDARY Change From Baseline in PGA Score by Visit |
-0.6; -0.7; -0.8; -1.0; -1.2; -1.0 | — |
| SECONDARY Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category |
— | — |
| SECONDARY Percentage of Participants by PGA Response Category and Timepoint |
88.9; 66.7; 11.1; 33.3; 44.4; 33.3 | — |
| SECONDARY Body Surface Area (BSA) |
34.16; 30.50; 31.20; 24.83; 24.20; 24.67 | — |
| SECONDARY Change From Baseline in BSA |
— | — |
| SECONDARY Percent Change From Baseline in BSA |
-6.87; -27.80; -22.51; -29.47; -35.13; -34.93 | — |
| SECONDARY Itch Severity Item (ISI) Score by Visit |
6.35; 3.46; 3.81; 3.90; 2.45; 1.99 | — |
| SECONDARY Change From Baseline in ISI by Visit |
-2.55; 0.45; -3.90; -1.47; -5.13; -0.79 | — |
| SECONDARY Target Plaque Severity Score (TPSS) by Visit |
8.7; 8.3; 7.1; 7.0; 6.0; 6.7 | — |
| SECONDARY Percent Change From Baseline in TPSS by Visit |
-16.69; -16.67; -29.78; -20.83; -47.55; -20.83 | — |
Summary
There are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. These activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque psoriasis for at least 12 months; in generally good health; on stable dose of non-prohibited medications; able to stop current psoriasis therapy (systemic or topical) for several weeks prior to and during study participation.
Exclusion Criteria
- Serious underlying disease including viral disorders such as hepatitis or HIV or skin condition that would interfere with skin biopsies or evaluation of psoriasis; conditions that could interfere with drug absorption after oral administration; history of malignancy or auto-immune disease.
- Use of oral or injected corticosteroids (steroids).
Data sourced from ClinicalTrials.gov (NCT01710046). 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.