Psoriasis
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Psoriasis
77242113PSO3002 Enrolling

Moderate to Severe Plaque Psoriasis Research Study 2 (165 Weeks)


Treatment: Oral Age: 18 Years


Who Can Participate?

Adults (≥18 years of age) with plaque psoriasis may be eligible to participate.

Inclusion Criteria:

      • Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks
      • Total body surface area (BSA) ≥10%
      • Moderate to severe plaque psoriasis
      • Candidate for phototherapy or systemic treatment for plaque psoriasis

How Long Will The Study Last?

      • 165 weeks (24 visits)

Participants will receive either an investigational oral treatment (active study drug), comparator drug, or placebo.

Reimbursement for study-related expenses will be provided.


Participating Locations

Participating Experts

Dr. David N. Adam

Dermatologist

Dr. Maryam Shayesteh Alam

Dermatologist

Dr. Lorne Albrecht

Dermatologist

Dr. Victoria Farley

Dermatologist

Dr. Kim Alexander Papp

Dermatologist

Dr. Darryl P. Toth

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: April 07, 2024

Official Title

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

ClinicalTrials.gov ID

NCT06143878

Sponsor

Janssen Research & Development, LLC

Study Description

  • Brief Summary:

    The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

  • Condition or Disease:

    Plaque Psoriasis

  • Intervention/Treatment:

    Drug: JNJ-77242113
    Drug: JNJ-77242113
    Drug: JNJ-77242113
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
Total psoriasis area and severity index (PASI) >=12 at screening and baseline
Total investigator global assessment (IGA) >=3 at screening and baseline
Candidate for phototherapy or systemic treatment for plaque psoriasis

Exclusion Criteria:

Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib, or to any of the excipients or components of the study intervention
Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study


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.



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