Clinical trial NCT01246583: CP-690-550 Ointment For Chronic Plaque Psoriasis
Official title: A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Multi Site
Randomized
Placebo Controlled
Double Blind
Parallel Group
chronic plaque psoriasis
topical treatment
skin diseases
papulosquamous
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
* A target plaque of at least 9 sq. cm.

Exclusion Criteria:

* Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
* Non plaque form of psoriasis;
* Currently have or history of psoriatic arthritis;
* Current drug induced psoriasis;
* Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
* Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months

Primary outcomes:
measure: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3
timeFrame: Baseline, Weeks 1, 2, 3
measure: Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4
timeFrame: Baseline, Weeks 1, 2, 3, 4
measure: Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of "Clear" (0) or "Almost Clear" (1)
timeFrame: Week 1, 2, 3, 4
measure: Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score
timeFrame: Week 1, 2, 3, 4
measure: Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Itch Severity Item (ISI)
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category
timeFrame: Week 4
measure: Number of Participants With Administration Site Adverse Events
timeFrame: Baseline up to follow up visit (Day 36-39 after last dose of study treatment) (up to maximum of 9.5 weeks)
measure: Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Number of Participants With Draize Score of Perilesional Skin in The Treatment Area
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Change From Baseline in Heart Rate at Week 1, 2, 3, 4
timeFrame: Baseline, Week 1, 2, 3, 4
measure: Change From Baseline in Electrocardiogram (ECG) Findings at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Hemoglobin Level at Week 2, 4
timeFrame: Baseline, Week 2, 4
measure: Change From Baseline in Platelet and Neutrophil Count at Week 2, 4
timeFrame: Baseline, Week 2, 4
measure: Change From Baseline in Creatinine Level at Week 2, 4
timeFrame: Baseline, Week 2, 4
measure: Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4
timeFrame: Baseline, Week 2, 4
measure: Plasma Concentration of CP-690,550
timeFrame: 0 (predose), 1, 2 and 4-9 hours postdose on Day 29 or early termination
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Horizon Research Group, Inc.
state: Alabama
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: Expresscare Medical
state: California
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ports WC, Khan S, Lan S, Lamba M, Bolduc C, Bissonnette R, Papp K. A randomized phase 2a efficacy and safety trial of the topical Janus kinase inhibitor tofacitinib in the treatment of chronic plaque psoriasis. Br J Dermatol. 2013 Jul;169(1):137-45. doi: 10.1111/bjd.12266.