Phase 3
Completed N=95
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
Source: ClinicalTrials.gov NCT01519089 ↗Enrolled (actual)
95
Serious AEs
6.4%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 — 62.8; 72.7; 67.8 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 |
62.8; 72.7; 67.8 | — |
| PRIMARY Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 |
67.4; 68.2; 67.8 | — |
| PRIMARY Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 |
100; 100; 100 | — |
| PRIMARY Number of Participants With Adjudicated Cardiovacular Events |
0; 0; 0 | — |
| PRIMARY Number of Participants With Malignancy Events _Week 0 Through Follow-up |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response |
2.3; 4.5; 3.4; 7.0; 22.7; 14.9 | — |
| SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response |
9.3; 22.7; 16.1; 34.9; 56.8; 46.0 | — |
| SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response |
0.0; 0.0; 0.0; 4.7; 13.6; 9.2 | — |
| SECONDARY Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' |
8.0; 8.0; 8.0 | — |
| SECONDARY Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response |
12.0; 8.0; 12.0 | — |
| SECONDARY Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response |
8.0; 4.0; 8.0 | — |
| SECONDARY Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response |
NA; 12.0; 16.0 | — |
| SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score |
2.3; 0.0; 1.1; 0.0; 2.3; 1.1 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
-5.18; -7.36; -6.28; -10.40; -13.16; -11.79 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score |
-0.5; -0.9; -0.7; -0.5; -0.8; -0.6 | — |
| SECONDARY Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' |
7.0; 15.9; 11.5; 30.2; 38.6; 34.5 | — |
| SECONDARY Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category |
0; 0; 0; 7.0; 15.9; 11.5 | — |
| SECONDARY Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 |
96.3; 87.5; 91.5; 92.6; 78.1; 84.7 | — |
| SECONDARY Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' |
100; 83.3; 91.5; 93.1; 73.3; 83.1 | — |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score |
-3.3; -1.8; -2.6; -11.2; -9.4; -10.4 | — |
| SECONDARY Number of Affected Nails |
7.94; 7.13; 7.55; 7.66; 7.11; 7.40 | — |
| SECONDARY Itch Severity Item (ISI) Score |
6.16; 5.32; 5.74; 5.19; 3.30; 4.23 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Score |
11.3; 8.6; 9.9; 7.8; 5.8; 6.8 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score |
1.951; 4.809; 3.329; 6.160; 5.130; 5.664 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score |
4.719; 6.146; 5.407; 6.767; 5.029; 5.929 | — |
| SECONDARY Work Limitation Questionnaire (WLQ) |
44.49; 42.36; 43.38; 66.67; 78.40; 72.71 | — |
| SECONDARY Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Joint Pain Assessment (JPA) |
5.25; 4.60; 4.83; 4.00; 1.36; 2.32 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response |
0.0; 62.5; 41.7; 50.0; 75.0; 66.7 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response |
0.0; 25.0; 16.7; 25.0; 50.0; 41.7 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response |
0.0; 0.0; 0.0; 0.0; 37.5; 25.0 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count |
-1.8; -3.5; -2.9; -6.3; -9.3; -8.3 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count |
-1.8; -3.8; -3.1; -5.0; -5.3; -5.2 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain |
-13.3; -29.5; -24.1; -13.0; -41.4; -31.9 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis |
-8.0; -32.6; -24.4; -20.5; -43.4; -35.8 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis |
-15.3; -28.5; -24.1; -32.5; -34.6; -33.9 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) |
-1.20; -1.68; -1.52; -1.20; -1.69; -1.53 | — |
| SECONDARY Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) |
-0.19; -0.28; -0.25; -0.28; -0.36; -0.33 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01519089). 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. Informational only — not medical advice.