CompletedPhase 3NCT01186744
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCP-690,550 and CP-690,550

Plus 2 other study approaches.

Who it may be forPsoriasis

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 26, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?87 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Pfizer
Interventions being studied
Drug: CP-690,550; Drug: CP-690,550; Drug: CP-690,550; Drug: CP-690,550
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Horizon Research Group, Inc.Mobile, Alabama
  • Radiant Research, Inc.Tucson, Arizona
  • Center for Dermatology Clinical Research, Inc.Fremont, California
  • Associates In Research, Inc.Fresno, California
  • Dermatology Research AssociatesLos Angeles, California
  • Expresscare MedicalLos Angeles, California
  • Dermatology Specialists, Inc.Oceanside, California
  • University of California San FranciscoSan Francisco, California
  • Longmont Clinic, PCLongmont, Colorado
  • New England Research Associates, LLCTrumbull, Connecticut
  • Florida Academic Dermatology CenterMiami, Florida
  • International Dermatology Research, Inc.Miami, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 26, 2018. Always confirm current availability with the study team.

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