Topical CP-690,550 For Chronic Plaque Psoriasis

NCT00678561 | Completed Phase 2 Results

• 1 other identifier: A3921038
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 20

Brief Summary

Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.

Conditions

Psoriasis

Keywords

chronic plaque psoriasis; topical treatment

Outcome Measures

Primary Outcomes (1)

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

  TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.

  Baseline, Week 4

Secondary Outcomes (5)

• Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions

  Week 4

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

  Baseline, Week 1, 2, 3

• Number of Participants With Administration Site Adverse Events

  Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)

• Drug Plasma Concentrations of CP-690,555

  0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28

• Skin Biopsy Drug Concentrations

  Day 28

Study Arms (8)

2% CP-690,550 QD

EXPERIMENTAL

Drug: CP-690,550

0.2% CP-690,550 QD

EXPERIMENTAL

Drug: CP-690,550

0.02% CP-690,550 QD

EXPERIMENTAL

Drug: CP-690,550

2% CP-690,550 BID

EXPERIMENTAL

Drug: CP-690,550

0.2% CP-690,550 BID

EXPERIMENTAL

Drug: CP-690,550

0.02% CP-690,550 BID

EXPERIMENTAL

Drug: CP-690,550

Placebo Vehicle QD

PLACEBO COMPARATOR

Drug: Placebo Vehicle

Placebo Vehicle BID

PLACEBO COMPARATOR

Drug: Placebo Vehicle

Interventions

CP-690,550 DRUG

Topical treatment once daily for 28 days

2% CP-690,550 QD

Placebo Vehicle DRUG

Topical treatment once daily for 28 days

Placebo Vehicle QD

Eligibility Criteria

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

You may qualify if:

• Having chronic plaque psoriasis for at least 6 months
• Able to withdraw all prior psoriasis treatments
• Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

You may not qualify if:

• Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
• Pregnant or lactating women
• Unwilling to use appropriate contraceptive methods

Sponsors & Collaborators

• Pfizer: lead

Study Sites (20)

University of California Irvine

Irvine, California, 92697, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-0314, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432-3134, United States

Location

Central Dermatology, PC

St Louis, Missouri, 63117, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

The Imaging Center

High Point, North Carolina, 27262, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Medical Research Center, PC

Portland, Oregon, 97223, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Guildford Dermatology Specialists

Surrey, British Columbia, V3R 6A7, Canada

Location

NewLab Clinical Research Inc.

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

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, Feldman SR, Gupta P, Tan H, Johnson TR, Bissonnette R. Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design. J Drugs Dermatol. 2015 Aug;14(8):777-84.

  PMID: 26267721 DERIVED

Related Links

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

MeSH Terms

Conditions

Psoriasis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; 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: May 13, 2008
• First Posted: May 15, 2008
• Study Start: October 13, 2008
• Primary Completion: July 9, 2009
• Study Completion: July 24, 2009
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (14); CA (6)