Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

NCT01710046 | Completed Phase 2 Results DMC

• 1 other identifier: A3921147
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

Brief Summary

There are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. These activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.

Conditions

Plaque Psoriasis

Keywords

plaque psoriasis; tofacitinib; biopsy; Janus Kinase; randomized placebo controlled clinical trial; psoriasis vulgaris

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12

  Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.

  Week 12

• Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12

  PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1.

  Week 12

Secondary Outcomes (14)

• Psoriasis Area and Severity Index (PASI) Score by Visit

  Baseline and Weeks 1, 2, 4, and 12

• Change From Baseline in PASI by Visit

  Weeks 1, 2, 4 and 12

• Percent Change From Baseline in PASI by Visit

  Weeks 1, 2, 4, and 12

• Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4

  Weeks 1, 2, and 4

• Change From Baseline in PGA Score by Visit

  Weeks 1, 2, 4, and 12

Study Arms (2)

Cohort 1

EXPERIMENTAL

Drug: (CP-6890,550) Tofacitinib; Drug: Placebo

Cohort 2

EXPERIMENTAL

Drug: (CP-690,550) Tofacitinib; Drug: Placebo

Interventions

(CP-6890,550) Tofacitinib DRUG

2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Cohort 1

Placebo DRUG

2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Cohort 1

(CP-690,550) Tofacitinib DRUG

2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks

Cohort 2

Eligibility Criteria

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

You may qualify if:

• Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque psoriasis for at least 12 months; in generally good health; on stable dose of non-prohibited medications; able to stop current psoriasis therapy (systemic or topical) for several weeks prior to and during study participation.

You may not qualify if:

• Serious underlying disease including viral disorders such as hepatitis or HIV or skin condition that would interfere with skin biopsies or evaluation of psoriasis; conditions that could interfere with drug absorption after oral administration; history of malignancy or auto-immune disease.
• Use of oral or injected corticosteroids (steroids).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Center for Clinical Studies

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.

  PMID: 32816215 DERIVED

• Krueger J, Clark JD, Suarez-Farinas M, Fuentes-Duculan J, Cueto I, Wang CQ, Tan H, Wolk R, Rottinghaus ST, Whitley MZ, Valdez H, von Schack D, O'Neil SP, Reddy PS, Tatulych S; A3921147 Study Investigators. Tofacitinib attenuates pathologic immune pathways in patients with psoriasis: A randomized phase 2 study. J Allergy Clin Immunol. 2016 Apr;137(4):1079-1090. doi: 10.1016/j.jaci.2015.12.1318.

  PMID: 27059729 DERIVED

Related Links

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

MeSH Terms

Interventions

tofacitinib

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
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 13, 2015
• Results First Posted: April 13, 2015

Record last verified: 2015-03

Locations

US (5)