A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis - Full Text View

Purpose

The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Condition	Intervention	Phase
Psoriasis	Drug: CP-690,550	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Proportion of participants maintaining a PASI75 response (at least a 75% reduction PASI relative to baseline) during the 16 week double blind active or placebo treatment period (CP- 690,550 treatment withdrawal; Period B) [ Time Frame: Weeks 28,32,36,40 ] [ Designated as safety issue: No ]
Proportion of participants maintaining a PGA response (PGA of "clear" or "almost clear") during 16 week double blind active or placebo treatment period (CP-690,550 treatment withdrawal; Period B) [ Time Frame: Weeks 28,32,36,40 ] [ Designated as safety issue: No ]
Participants who had a >50% reduction of the Visit A4/Week 24 PASI response during CP-690,550 treatment withdrawal, the proportion of participants achieving a PASI75 response relative to Baseline/Day 1 during CP-690,550 re-treatment (Period C). [ Time Frame: Weeks 32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Participants with a PGA of "mild", "moderate", or "severe" during withdrawal, the proportion of participants achieving a PGA response (PGA of "clear" or "almost clear") during re-treatment (Period C) [ Time Frame: Weeks 32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Psoriasis Area and Severity Index 75 (PASI75) response during initial CP-690,550 treatment (Period A) [ Time Frame: Baseline, Weeks 4,8,16,24 ] [ Designated as safety issue: No ]
Time to Physicians Global Assessment (PGA) response during initial CP-690,550 treatment (Period A) [ Time Frame: Baseline, Weeks 4,8,16,24 ] [ Designated as safety issue: No ]
Time to loss of adequate response, defined as >50% reduction of the Visit A4/Week 24 PASI response during the 16-week double-blind active or placebo treatment period (CP-690,550 treatment withdrawal; Period B) [ Time Frame: Baseline, Weeks 28,32,36,40 ] [ Designated as safety issue: No ]
Time to Psoriasis Area and Severity Index 75 (PASI75) response during CP-690,550 re-treatment (Period C) [ Time Frame: Baeline, Weeks 32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Time to Physicians Global Assessment (PGA) response during CP-690,550 re-treatment (Period C) [ Time Frame: Baseline, Weeks 32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Physicians Global Assessment (PGA) response [ Time Frame: Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Actual and change from baseline in Psoriasis Area and Severity Index (PASI) and component scores [ Time Frame: Baseline, Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Proportion of participants achieving at least a 50% and 90% reduction in Psoriasis Area Severity Index (PASI) relative to baseline (PASI50 and PASI90, respectively) at various timepoints through Week 56 [ Time Frame: Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Proportion of participants with a PASI score > or equal 125% of the baseline PASI score at various timepoints through Week 56 [ Time Frame: Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Proportion of participants in each Physicians Global Assessment (PGA) category [ Time Frame: Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Actual and change from baseline in the Itch Severity Item (ISI) score [ Time Frame: Baseline, Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Actual and change from baseline on the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Short Form 36 Health Survery (SF-36) -Version 2, Acute [ Time Frame: Weeks 24,28,32,36,40,56 ] [ Designated as safety issue: No ]
Patient Global Assessment of Psoriasis (PtGA) [ Time Frame: Weeks 4,8,16,24,28,32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
EuroQol 5 Dimensions (EQ-5D) [ Time Frame: Weeks 24,28,32,36,40,56 ] [ Designated as safety issue: No ]
Proportion of participants with rebound (worsening of psoriasis over baseline value [PASI>125%] or new type of psoriasis (pustular,erythrodermic) during the period between Week 24 and Week 32 [ Time Frame: Weeks 24, 32 ] [ Designated as safety issue: No ]
Proportion of participants with worsening psoriasis over baseline value (%change from baseline PASI>125%) or new type of psoriasis during 16 week double blind active or placebo treatment period (CP-690,550 treatment withdrawal; Period B) [ Time Frame: Weeks 28,32,36,40 ] [ Designated as safety issue: No ]
Time to loss of at least 50% Visit A4/Week 24 PASI response and loss of PGA response (PGA 'clear' or 'almost clear')during 16 week double blind active or placebo treatment (CP 690,550 treatment withdrawal;Period B) [ Time Frame: Weeks 28,32,36,40 ] [ Designated as safety issue: No ]
Time to regain PASI75 and PGA response (PGA of 'clear' or 'almost clear') during CP- 690,550 re-treatment (Period C) [ Time Frame: Weeks 32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]
Proportion of participants regaining PASI75 and PGA response (PGA of 'clear' or 'almost clear') during CP-690,550 re-treatment (Period C) [ Time Frame: Weeks 32,36,40,44,48,52,56 ] [ Designated as safety issue: No ]

Enrollment:	684
Study Start Date:	September 2010
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active Treatment (10 mg) BID / Placebo BID Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks	Drug: CP-690,550 10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
Experimental: Active Treatment (10 mg) BID Continuous active treatment (CP-690,550) for 56 weeks	Drug: CP-690,550 10 mg oral BID
Experimental: Active Treatment (5 mg) BID / Placebo BID Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks	Drug: CP-690,550 5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
Experimental: Active Treatment (5 mg) BID Continuous active treatment (CP-690,550) for 56 weeks	Drug: CP-690,550 5 mg oral BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug;
Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at least 10% of body surface area;
No evidence of active or latent or inadequately treated infection with Tuberculosis or other serious infections.

Exclusion Criteria:

Non-plaque or drug induced forms of psoriasis;
Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
Any uncontrolled significant medical condition.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186744

Show 87 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01186744 History of Changes
Other Study ID Numbers:	A3921111
Study First Received:	August 20, 2010
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

chronic
moderate
severe
treatment
safety
treatment withdrawal

retreatment
CP-690
550
Psoriasis Vulgaris
Plaque Psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013