Phase 3
N=901
A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01276639 ↗Enrolled (actual)
901
Serious AEs
5.8%
Results posted
Sep 2014
Primary outcome: Primary: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 — 41.87; 59.17; 9.04 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CP-690,550 (Drug); Placebo/CP-690,550 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2013
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 |
41.87; 59.17; 9.04 | <0.0001 sig |
| PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 |
39.94; 59.17; 6.21 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 |
-51.94; -67.20; 1.62 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16 |
19.83; 39.44; 0.56 | <0.0001 sig |
| SECONDARY Dermatology Life Quality Index (DLQI) Total Score |
12.46; 12.87; 14.01 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 |
-5.59; -6.40; -1.69; -6.91; -8.90; -1.93 | <0.0001 sig |
| SECONDARY Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4 |
17.08; 23.06; 2.26 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4 |
10.47; 15.56; 1.69 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 |
-14.15; -41.48; 55.55 | <0.0001 sig |
| SECONDARY Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52 |
60.17; 71.56 | — |
| SECONDARY Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52 |
73.75; 79.94 | — |
| SECONDARY Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52 |
61.79; 70.58 | — |
| SECONDARY Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' |
16.0; 12.0; NA | <0.0001 sig |
| SECONDARY Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response |
NA; 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' |
5.23; 10.00; 3.03; 0.00; 17.08; 23.06 | — |
| SECONDARY Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response |
1.38; 2.22; 0.00; 0.00; 10.47; 15.56 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Score |
21.95; 22.73; 21.19; 23.03; 18.28; 17.30 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-3.87; -5.31; -1.79; -0.81; -7.61; -9.48 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Component Scores |
2.31; 2.23; 2.38; 2.26; 2.87; 2.88 | — |
| 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 |
-0.45; -0.51; -0.24; -0.06; -0.46; -0.63 | — |
| 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 |
-18.50; -24.86; -8.99; -5.85; -34.60; -43.08 | — |
| SECONDARY Total Body Surface Area (BSA) With Psoriasis |
28.48; 31.13; 28.03; 30.17; 27.08; 27.86 | — |
| 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 |
-6.89; -10.44; -1.92; -1.23; -18.31; -26.73 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response |
9.09; 17.22; 3.03; 0.00; 28.65; 39.72 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response |
0.28; 0.00; 0.00; 0.00; 1.65; 3.89 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score |
0.56; 1.12; 4.55; 3.13; 1.14; 0.57 | — |
| SECONDARY Nail Psoriasis Severity Index (NAPSI) Score |
26.64; 28.24; 26.76; 23.91; 24.32; 22.47 | — |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 |
-2.58; -5.55; -0.82; 0.70; -6.91; -11.70 | — |
| SECONDARY Number of Affected Nails |
7.21; 7.71; 7.73; 7.24; 6.87; 6.65 | — |
| SECONDARY Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 |
2.58; -19.37; 16.91; 36.22; -14.13; -42.26 | — |
| SECONDARY Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response |
9.72; 14.40; 8.82; 4.35; 14.98; 29.20 | — |
| SECONDARY Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response |
8.10; 12.40; 5.88; 4.35; 10.12; 20.00 | — |
| SECONDARY Itch Severity Item (ISI) Score |
5.49; 5.59; 5.64; 5.94; 3.74; 3.32 | — |
| SECONDARY Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-1.76; -2.25; -0.13; -0.06; -2.62; -3.16 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Score |
12.46; 12.87; 13.83; 14.68; 8.65; 8.32 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 |
-4.02; -4.56; -1.94; -1.07; -5.65; -6.41 | — |
| SECONDARY 36-Item Short-Form Health Survey Version 2, Acute (SF-36) |
47.36; 47.02; 47.12; 44.86; 42.98; 43.35 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Score |
6.58; 6.21; 6.94; 7.06; 5.20; 5.09 | — |
| SECONDARY Work Limitation Questionnaire (WLQ) Index Score |
7.40; 7.90; 7.16; 8.40; 6.92; 6.64 | — |
| SECONDARY Percentage of Participants With Patient Global Assessment (PtGA) Scale Response |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response |
6.0; 6.3; 12.3; 13.6; 3.2; 1.5 | — |
| SECONDARY Joint Pain Assessment (JPA) Score |
3.42; 2.96; 3.00; 3.69; 2.24; 2.13 | — |
| SECONDARY Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score |
0.77; 0.77; 0.78; 0.74; 0.86; 0.88 | — |
| SECONDARY Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) |
67.28; 66.97; 68.65; 65.24; 76.00; 77.95 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional |
3; 5; 2; 24; 34; 14 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work |
55; 47; 27; 182; 185; 87 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status |
100.00; 94.59; 100.00; 74.42; 71.94; 66.92 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours |
8.61; 8.15; 7.92; 5.15; 6.00; 5.81 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours |
60.32; 72.84; 75.76; 64.15; 65.21; 71.81 | — |
| SECONDARY Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work |
2.23; 2.13; 2.89; 1.13; 1.26; 1.94 | — |
| SECONDARY Family Dermatology Life Quality Index (FDLQI) Score |
9.45; 9.41; 9.40; 8.80; 3.76; 3.53 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
- a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
- 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 (NCT01276639). 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.