Phase 3
Completed N=266
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT01815424 ↗Enrolled (actual)
266
Serious AEs
2.0%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 — 75.56; 52.27; 19.32 percentage of participants — p=<0.0001
◆ Published Evidence
Established
86citations · ~10 / year
The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study.
Summary
The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Linked Publications
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The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 |
75.56; 52.27; 19.32 | <0.0001 sig |
| PRIMARY Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 |
81.11; 54.55; 12.50 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 |
-73.81; -54.39; -2.27 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16 |
60.00; 35.23; 3.41 | <0.0001 sig |
| SECONDARY Change From Baseline in DLQI Total Score at Week 16 |
-9.10; -7.03; -1.57 | <0.0001 sig |
| SECONDARY Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4 |
37.78; 19.32; 1.14 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving PASI75 Response at Week 4 |
24.44; 4.55; 0.00 | <0.0001 sig |
| SECONDARY Change From Baseline in DLQI Total Score at Week 4 |
-6.03; -5.14; -0.94 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline |
-33.32; -14.98; 7.91 | 0.0113 sig |
| SECONDARY Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response at Week 16 |
75.00; 73.63 | — |
| SECONDARY Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16 |
84.93; 76.82 | — |
| SECONDARY Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16 |
74.07; 70.45 | — |
| SECONDARY Time to PGA Response up to Week 16 |
8.0; 14.0; NA | — |
| SECONDARY Time to PASI75 Response up to Week 16 |
8.0; 16.0; NA | — |
| SECONDARY Time to PASI50 Response up to Week 16 |
4.0; 8.0; NA | — |
| SECONDARY Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 |
3.33; 2.27; 0.00; 0.00; 37.78; 19.32 | — |
| SECONDARY Percentage of Participants in Each PGA Category Over Time Through Week 52 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 |
1.11; 0.00; 0.00; 0.00; 24.44; 4.55 | — |
| SECONDARY Actual PASI Scores Over Time Through Week 52 |
25.34; 25.32; 25.62; 26.51; 19.03; 21.23 | — |
| SECONDARY Change From Baseline in PASI Over Time Through Week 52 |
-6.40; -4.26; 0.10; -0.04; -11.74; -7.91 | — |
| SECONDARY PASI Component Scores Over Time Through Week 52 |
2.31; 2.18; 2.18; 2.39; 1.74; 1.77 | — |
| SECONDARY Change From Baseline in PASI Component Scores Over Time Through Week 52 |
-0.56; -0.41; -0.14; 0.10; -0.94; -0.74 | — |
| SECONDARY Percent Change From Baseline in PASI Scores Over Time Through Week 52 |
-24.93; -16.28; 1.37; -0.35; -46.24; -32.47 | — |
| SECONDARY Actual BSA Over Time Through Week 52 |
36.36; 37.41; 35.29; 36.25; 33.95; 36.56 | — |
| SECONDARY Percent Change From Baseline in BSA Over Time Through Week 52 |
-5.58; -2.53; 4.79; 2.14; -21.90; -10.98 | — |
| SECONDARY Percentage of Participants With PASI50 Response Over Time Through Week 52 |
21.11; 5.68; 0.00; 0.00; 48.89; 27.27 | — |
| SECONDARY Percentage of Participants With PASI90 Response Over Time Through Week 52 |
0.00; 0.00; 0.00; 0.00; 7.78; 2.27 | — |
| SECONDARY Percentage of Participants With PASI125 Over Time Through Week 52 |
2.27; 1.16; 4.55; 4.76; 2.30; 1.14 | — |
| SECONDARY Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline |
25.8; 26.2; 28.7; 25.2; 23.0; 23.6 | — |
| SECONDARY Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline |
-3.60; -2.76; 2.17; 2.64; -9.38; -6.63 | — |
| SECONDARY Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 |
7.6; 7.3; 8.1; 7.4; 7.2; 7.2 | — |
| SECONDARY Percent Change From Baseline in NAPSI Over Time Through Week 52 |
-9.59; -8.81; 5.28; 25.40; -33.31; -14.91 | — |
| SECONDARY Percentage of Participants With NAPSI75 Response Over Time Through Week 52 |
0.00; 10.53; 5.56; 0.00; 20.00; 15.79 | — |
| SECONDARY Percentage of Participants With NAPSI100 Response Over Time Through Week 52 |
0.00; 5.26; 0.00; 0.00; 5.00; 5.26 | — |
| SECONDARY Actual Itch Severity Item (ISI) Score Over Time Through Week 52 |
5.66; 5.10; 5.22; 5.75; 2.97; 3.49 | — |
| SECONDARY Change From Baseline in ISI Score Over Time Through Week 52 |
-2.50; -1.76; 0.12; -0.64; -3.33; -2.60 | — |
| SECONDARY Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 |
14.1; 13.5; 12.5; 12.1; 9.5; 10.0 | — |
| SECONDARY Change From Baseline in DLQI Score Over Time Through Week 52 |
-3.98; -3.26; -0.20; -2.27; -5.96; -5.11 | — |
| SECONDARY Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 |
0.00; 0.00; 0.00; 0.00; 7.78; 5.68 | — |
| SECONDARY Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 |
0.784; 0.797; 0.779; 0.741; 0.957; 0.930 | — |
| SECONDARY Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 |
0.172; 0.128; 0.105; 0.074; 0.170; 0.109 | — |
| SECONDARY Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 |
65.8; 69.5; 66.4; 67.4; 83.7; 78.9 | — |
| SECONDARY Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 |
17.5; 8.8; 2.6; -0.6; 18.4; 13.1 | — |
Eligibility Criteria
Inclusion Criteria
- Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to the first screening procedure.
- Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline (Day 1).
- Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).
Exclusion Criteria
- Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed.
- Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
- Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study are excluded.
Data sourced from ClinicalTrials.gov (NCT01815424) and the linked publication. 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.