Psoriasis
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Psoriasis
CR109163 Enrolling

Moderate to Severe Plaque OR Scalp Psoriasis Trial (116 Weeks)


Treatment: Injection Age: 18 Years

Adults at least 18 years of age who self-identify as non-white, may qualify to participate.  Must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study drug OR expert panel confirmed psoriasis diagnosis (based on clinical photos) OR biopsy confirmed psoriasis.  Individuals must also have moderate to severe plaque psoriasis, with involvement of 10% or more body surface area (BSA) OR have moderate to severe scalp psoriasis, with involvement of 30% or more scalp surface area and at least one plaque outside of the scalp.

Participants will receive investigational treatment (active study drug) or placebo, via injection.  Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last about 116 weeks and involve about 20 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Skin of Color Who Have Moderate-to-Severe Plaque Psoriasis and/or Moderate-to-Severe Scalp Psoriasis

ClinicalTrials.gov ID

NCT05272150

Sponsor

Janssen Research & Development, LLC

Study Description

  • Brief Summary:

    The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of psoriasis.

  • Condition or Disease:

    Plaque Psoriasis

  • Intervention/Treatment:

    Drug: Guselkumab
    Drug: Guselkumab
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug
Self-identify as non-white or non-caucasian
Be a candidate for phototherapy or systemic treatment for psoriasis
Have an involved body surface area (BSA) greater than or equal to (>=) 10 percent (%), psoriasis area and severity index (PASI) >=12, investigator global assessment (IGA) >=3 at screening and at baseline (Cohort A), or have a scalp surface area >=30%, psoriasis scalp severity index (PSSI) >=12, scalp specific investigator global assessment (ss-IGA) >=3, and one plaque outside of the scalp at screening and at baseline (Cohort B)
Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention

Exclusion Criteria:

Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)
Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug
Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening


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


Participating Experts

Dr. G. Daniel Schachter

Dermatologist

Dr. Sameh Hanna

Dermatologist

Dr. Maxwell Sauder

Dermatologist

Dr. Anatoli Freiman

Dermatologist

Dr. Benjamin Barankin

Dermatologist

Dr. Jennifer Beecker

Dermatologist

Dr. Firouzeh Niakosari

Dermatologist

Dr. David N. Adam

Dermatologist

Dr. Chih-ho Hong

Dermatologist

Dr. Lorne Albrecht

Dermatologist

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