CP-690-550 Ointment For Chronic Plaque Psoriasis

NCT01246583 | Completed Phase 2 Results

• 1 other identifier: A3921116
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 12

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.

Conditions

Psoriasis

Keywords

Multi Site; Randomized; Placebo Controlled; Double Blind; Parallel Group; chronic plaque psoriasis; topical treatment; skin diseases; papulosquamous

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4

  Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis.

  Baseline, Week 4

Secondary Outcomes (19)

• Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3

  Baseline, Weeks 1, 2, 3

• Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4

  Baseline, Weeks 1, 2, 3, 4

• Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of "Clear" (0) or "Almost Clear" (1)

  Week 1, 2, 3, 4

• Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score

  Week 1, 2, 3, 4

• Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4

  Baseline, Week 1, 2, 3, 4

Study Arms (4)

Treatment Group A

EXPERIMENTAL

Drug: CP-690,550 Ointment 1

Treatment Group B

PLACEBO COMPARATOR

Drug: Vehicle 1

Treatment Group C

EXPERIMENTAL

Drug: CP-690,550 Ointment 2

Treatment Group D

PLACEBO COMPARATOR

Drug: Vehicle 2

Interventions

CP-690,550 Ointment 1 DRUG

2% CP-690,550 Ointment 1 twice daily for 4 weeks

Treatment Group A

Vehicle 1 DRUG

Vehicle 1 twice daily for 4 weeks

Treatment Group B

CP-690,550 Ointment 2 DRUG

2% CP-690,550 Ointment 2 twice daily for 4 weeks

Treatment Group C

Vehicle 2 DRUG

Vehicle 2 twice daily for 4 weeks

Treatment Group D

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Horizon Research Group, Inc.

Mobile, Alabama, 36608, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Expresscare Medical

Los Angeles, California, 90045, United States

Location

Park Avenue Dermatology, PA

Orange Park, Florida, 32073, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Modern Research Associates, PLLC

Dallas, Texas, 75231, United States

Location

K.Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

Location

Siena Medical Research

Montreal, Quebec, H3Z 2S6, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Related Publications (1)

• 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.

  PMID: 23387374 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: February 16, 2011
• Primary Completion: November 29, 2011
• Study Completion: November 29, 2011
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (8); CA (4)