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77242113PSO3001 Enrolling

Moderate to Severe Plaque Psoriasis Research Study (165 Weeks)


Treatment: Oral Age: 12 Years


Who Can Participate?

Adolescents and adults (≥12 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
      • Participants ≥12 to <18 years of age, body weight must be ≥40 kg

 

How Long Will The Study Last?

      • 165 weeks (24 visits)

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

Reimbursement for study-related expenses may be provided.


Participating Experts

Dr. Benjamin Barankin

Dermatologist

Dr. Alim Devani

Dermatologist

Dr. Anatoli Freiman

Dermatologist

Dr. Chih-ho Hong

Dermatologist

Dr. Wei Jing Loo

Dermatologist

Dr. Vimal Prajapati

Dermatologist

Dr. Maxwell Sauder

Dermatologist

Dr. Sanjay Siddha

Dermatologist

Dr. Darryl P. Toth

Dermatologist

Dr. Geeta Yadav

Dermatologist

Dr. Jensen Yeung

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: February 25, 2024

Official Title

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

ClinicalTrials.gov ID

NCT06095115

Sponsor

Janssen Research & Development, LLC

Study Description

  • Brief Summary:

    The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.

  • Condition or Disease:

    Plaque Psoriasis

  • Intervention/Treatment:

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

    Phase 3

  • Ages Eligible for Study:

    12 Years and older (Child)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Diagnosis of plaque psoriasis, with or without psoriatic arthritis, 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
A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

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 or its excipients
Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a 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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