Psoriasis
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Psoriasis
CR109193 Enrolling

Clinical Research Trial for Plaque Psoriasis (24 Weeks)


Treatment: Oral Age: 18 Years

Adults from 18 to 75 years of age with a diagnosis of plaque psoriasis, with or without psoriatic arthritis for at least 26 weeks, may qualify for this study.  Qualified participants must also have moderate to severe plaque psoriasis that covers a total of 10% or more body surface area (BSA).

 

Participants will receive investigational oral medication (active study drug) or placebo.  Study medication and study-related assessments will be provided.  Reimbursement for study-related expenses may be provided.

 

Study participation will last about 24 weeks and involve about 9 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: October 02, 2022

Official Title

A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Oral Tablet Formulation of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

ClinicalTrials.gov ID

NCT05357755

Sponsor

Janssen Research & Development, LLC

Study Description

  • Brief Summary:

    The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.

  • Condition or Disease:

    Plaque Psoriasis

  • Intervention/Treatment:

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

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
Participant has a total Body Surface Area (BSA) greater than or equal to (>=) 10 percentage (%) at screening and baseline
Participant has a total Psoriasis Area and Severity Index (PASI) >= 12 at screening and baseline
Participant has a total Investigator’s Global Assessment (IGA) >= 3 at screening and baseline
Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis

Exclusion Criteria:

Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Participant have previously received any other therapeutic agent directly targeted to interleukin 23 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
Participant has received any therapeutic agent directly targeted to interleukin 17 (IL-17), interleukin 17 receptor (IL-17R) or interleukin 12/23 (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received biological therapy targeting tumor necrosis factor (TNF) (including, but not limited to adalimumab, infliximab, or etanercept) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
Participant has received proton pump inhibitors (including but not limited to omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole, or zegerid) within 1 week of first administration of study intervention


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 Locations

COUNTRY
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Canada

Participating Experts

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati

Dermatologist

Dr. Maxwell Sauder

Dermatologist

Dr. Anatoli Freiman

Dermatologist

Dr. Benjamin Barankin

Dermatologist

Dr. Mark Lomaga

Dermatologist

Dr. Charles Lynde

Dermatologist

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