Phase 3
Completed N=960
A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT01309737 ↗Enrolled (actual)
960
Serious AEs
5.1%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 — 46.01; 59.09; 10.88 percentage of participants — p=<0.0001
Summary
The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 |
46.01; 59.09; 10.88 | <0.0001 sig |
| PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 |
46.01; 59.63; 11.40 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 |
-54.86; -67.22; -9.12 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16 |
24.47; 38.77; 5.18 | <0.0001 sig |
| SECONDARY Dermatology Life Quality Index (DLQI) Total Score |
13.22; 12.69; 13.19 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 |
-5.55; -6.88; -2.57; -7.28; -8.92; -2.82 | <0.0001 sig |
| SECONDARY Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4 |
17.02; 27.81; 5.18 | <.0001 sig |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4 |
7.45; 14.17; 4.15 | 0.1786 |
| SECONDARY Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 |
-21.62; -25.97; 15.82 | 0.0062 sig |
| SECONDARY Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52 |
63.55; 71.71 | — |
| SECONDARY Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52 |
74.38; 78.99 | — |
| SECONDARY Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52 |
70.33; 63.83 | — |
| SECONDARY Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' |
12.0; 8.0; NA | <0.0001 sig |
| SECONDARY Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response |
16.0; 12.0; NA | <0.0001 sig |
| SECONDARY Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response |
8.0; 8.0; NA | <0.0001 sig |
| SECONDARY Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' |
5.32; 9.63; 2.70; 3.95; 17.02; 27.81 | — |
| SECONDARY Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response |
1.33; 1.87; 0.00; 0.00; 7.45; 14.17 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Score |
22.96; 21.88; 22.58; 22.36; 18.62; 17.19 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-4.09; -4.94; -1.04; -2.87; -7.87; -9.47 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Component Scores |
2.30; 2.35; 2.36; 2.29; 2.90; 2.89 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-0.48; -0.56; -0.05; -0.22; -0.85; -1.01 | — |
| SECONDARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-18.21; -22.15; -5.07; -11.41; -34.62; -42.21 | — |
| SECONDARY Total Body Surface Area (BSA) With Psoriasis |
30.94; 28.49; 30.10; 30.27; 28.25; 26.40 | — |
| SECONDARY Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-7.62; -7.80; 1.77; -1.13; -18.73; -23.68 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response |
9.31; 12.30; 2.70; 6.58; 28.19; 41.44 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response |
0.27; 0.27; 0.00; 0.00; 2.66; 2.67 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score |
0.54; 1.09; 1.37; 1.32; 0.83; 1.09 | — |
| SECONDARY Nail Psoriasis Severity Index (NAPSI) Score |
27.31; 26.22; 25.40; 26.78; 22.36; 21.88 | — |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 |
-4.33; -4.21; -3.53; -1.04; -8.74; -9.36 | — |
| SECONDARY Number of Affected Nails |
7.45; 7.23; 7.21; 7.36; 6.50; 6.65 | — |
| SECONDARY Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 |
-11.95; 0.55; -14.70; 11.37; -21.56; -25.87 | — |
| SECONDARY Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response |
10.83; 11.95; 6.98; 1.82; 18.75; 26.99 | — |
| SECONDARY Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response |
7.92; 7.52; 2.33; 1.82; 10.42; 16.37 | — |
| SECONDARY Itch Severity Item (ISI) Score |
5.70; 5.51; 5.32; 5.08; 3.88; 3.47 | — |
| SECONDARY Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-1.72; -2.05; -0.44; -0.63; -2.39; -3.05 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Score |
13.22; 12.69; 13.05; 12.12; 9.07; 8.02 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-3.98; -4.70; -2.56; -2.95; -5.50; -6.89 | — |
| SECONDARY 36-Item Short-Form Health Survey Version 2, Acute (SF-36) |
46.80; 47.25; 47.39; 47.90; 43.24; 43.40 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Score |
7.05; 6.94; 7.72; 6.38; 6.00; 5.64 | — |
| SECONDARY Work Limitation Questionnaire (WLQ) Index Score |
7.77; 8.26; 7.63; 7.78; 6.89; 6.99 | — |
| SECONDARY Percentage of Participants With Patient Global Assessment (PtGA) Scale Response |
0; 0; 0; 0; 0.5; 0 | — |
| SECONDARY Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response |
48.4; 60.5; 10.8; 17.1; 24.9; 23.9 | — |
| SECONDARY Joint Pain Assessment (JPA) Score |
3.79; 3.44; 3.45; 2.96; 2.50; 2.22 | — |
| SECONDARY Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score |
0.76; 0.78; 0.79; 0.80; 0.85; 0.88 | — |
| SECONDARY Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) |
65.83; 67.38; 63.82; 65.05; 76.19; 78.43 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional |
4; 5; 2; 44; 44; 22 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work |
50; 59; 27; 168; 175; 95 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status |
100.00; 100.00; 100.00; 66.67; 74.60; 74.66 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours |
8.84; 8.56; 8.07; 5.86; 5.74; 5.74 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours |
64.89; 70.32; 73.36; 68.39; 72.88; 73.82 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work |
2.50; 2.61; 2.32; 1.15; 0.85; 2.07 | — |
| SECONDARY Family Dermatology Life Quality Index (FDLQI) Score |
9.20; 9.57; 8.07; 6.27; 4.17; 2.84 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
- A Psoriasis Area and Severity Index (PASI) score of 12 or greater
- Are considered to be candidates for systemic or light therapy
- Have no evidence of active or latent tuberculosis
Exclusion Criteria
- Non-plaque or drug-induced forms of psoriasis
- Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
- Any uncontrolled significant medical condition
Data sourced from ClinicalTrials.gov (NCT01309737). 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.