Psoriasis
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Psoriasis
IM011-237 Enrolling

Clinical Trial for Adults with Plaque Psoriasis (60 Weeks)


Treatment: Oral Age: 18 Years


Adults aged 18 or over diagnosed with stable plaque psoriasis for 6 months or more, may qualify to participate. Stable psoriasis is defined as no
morphology changes or significant flares of disease activity. Individuals must have psoriasis on 3% or more of body surface area (BSA) at
Screening Visit and Day 1. Eligible participants must not have other non-plaque psoriasis such as guttate, pustular, erythrodermic, palmoplantar-only involvement, or drug-induced psoriasis. Note: other eligibility criteria apply.
Participants will receive investigational oral medication (active study drug) or a placebo. Study medication and study-related assessments will be
provided at no cost. Reimbursement for study-related expenses may be provided. Note: the study doctor will discuss with you, the possible risks
related to this study.
Study participation will last approximately 60 weeks and involve about 16 visits to the study center.


Participating Locations

COUNTRY
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United States

The following information is from ClinicalTrials.gov

Last Update Posted: June 04, 2023

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

ClinicalTrials.gov ID

NCT05701995

Sponsor

Bristol-Myers Squibb

Study Description

  • Brief Summary:

    The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.

  • Condition or Disease:

    Psoriasis

  • Intervention/Treatment:

    Drug: Deucravacitinib
    Drug: Deucravacitinib
  • Phase:

    Phase 4

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria

Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
≥ 3% of Body Surface Area (BSA) involvement at Screening Visit and Day 1
Dermatology Life Quality Index (DLQI) score > 5 at Screening Visit and Day 1

Exclusion Criteria:

Target Disease Exceptions:

Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1

Other protocol-defined inclusion/exclusion criteria apply.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



Participating Experts

Dr. Alison Ehrlich

Dermatologist

Dr. Matthew Zirwas

Dermatologist

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