A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01815424
• Date of registration: 18/03/2013
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis
• Scientific title: A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN ASIAN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
• Date of first enrolment: December 2013
• Target sample size: 266
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01815424
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China, Korea, Republic of, Taiwan

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: placebo

Drug: CP-690,550

Primary Outcome(s)

Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 [Time Frame: Week 16]

Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 [Time Frame: Week 16]

Secondary Outcome(s)

Change From Baseline in DLQI Score Over Time Through Week 52 [Time Frame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52 [Time Frame: Baseline and Weeks 16, 32, 40, and 52]

Percentage of Participants With PASI90 Response Over Time Through Week 52 [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Change From Baseline in PASI Component Scores Over Time Through Week 52 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52 [Time Frame: Baseline, Weeks 16, 32, 40, 52]

Percent Change From Baseline in BSA Over Time Through Week 52 [Time Frame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Actual Itch Severity Item (ISI) Score Over Time Through Week 52 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Change From Baseline in PASI Over Time Through Week 52 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52 [Time Frame: Baseline and Weeks 8, 16, 20, 32, 40, and 52]

PASI Component Scores Over Time Through Week 52 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 [Time Frame: Baseline to Week 16]

Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52 [Time Frame: Baseline and weeks 16, 32, 40, and 52]

Percent Change From Baseline in PASI Scores Over Time Through Week 52 [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Actual PASI Scores Over Time Through Week 52 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52]

Change From Baseline in ISI Score Over Time Through Week 52 [Time Frame: Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Percentage of Participants Achieving PASI75 Response Over Time Through Week 52 [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Percentage of Participants With PGA Score of "Clear" or "Almost Clear" at Week 4 [Time Frame: Week 4]

Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline [Time Frame: Baseline and Weeks 8, 16, 20, 32, 40, and 52]

Percentage of Participants With NAPSI75 Response Over Time Through Week 52 [Time Frame: Weeks 8, 16, 20, 32, 40, and 52]

Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline [Time Frame: Baseline and weeks 8, 16, 20, 32, 40, and 52]

Percentage of Participants With PASI50 Response Over Time Through Week 52 [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Change From Baseline in DLQI Total Score at Week 16 [Time Frame: Baseline to Week 16]

Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52 [Time Frame: Baseline and weeks 16, 32, 40, and 52]

Percentage of Participants Achieving PASI75 Response at Week 4 [Time Frame: Week 4]

Percentage of Participants in Each PGA Category Over Time Through Week 52 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Percentage of Participants Maintaining PGA Score of "Clear" or "Almost Clear" at Week 52 Among Participants Achieving PGA Response at Week 16 [Time Frame: Week 16 to Week 52]

Percentage of Participants With NAPSI100 Response Over Time Through Week 52 [Time Frame: Weeks 8, 16, 20, 32, 40, and 52]

Percentage of Participants With PASI125 Over Time Through Week 52 [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Percentage of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Over Time Through Week 52 [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52 [Time Frame: Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Time to PGA Response up to Week 16 [Time Frame: Baseline to Week 16]

Time to PASI50 Response up to Week 16 [Time Frame: Baseline up to Week 16]

Actual BSA Over Time Through Week 52 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52]

Change From Baseline in DLQI Total Score at Week 4 [Time Frame: Baseline to Week 4]

Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline [Time Frame: Baseline to Week 16]

Percent Change From Baseline in NAPSI Over Time Through Week 52 [Time Frame: Baseline and weeks 8, 16, 20, 32, 40, and 52]

Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16 [Time Frame: Week 16]

Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16 [Time Frame: Week 16 to Week 52]

Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16 [Time Frame: Week 16 to Week 52]

Time to PASI75 Response up to Week 16 [Time Frame: Baseline up to Week 16]

Secondary ID(s)

A3921174

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01815424