Hidradenitis Suppurativa
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Hidradenitis Suppurativa
CR109063 Enrolling

Hidradenitis Suppurativa Clinical Research Trial (42 Weeks)


Treatment: Injection Age: 18 Years

Adults aged 18 years or older with Hidradenitis Suppurativa (HS) for at least 1 year, may qualify to participate. Individuals must have HS lesions present in at least 2 distinct anatomic areas, as well as moderate to severe disease. Qualified participants must also have an inadequate response to a course of appropriate oral antibiotics for treatment of HS, and have a total abscess and inflammatory nodule (AN) count of 5 or more.

During the placebo-controlled period, participants will receive investigational medication (active study drug), comparator medication, or placebo via injection. During the active treatment period, participants will receive active study drug or comparator medication. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Total study duration lasts about 42 weeks and involves about 35 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: October 02, 2022

Official Title

A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled, Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa

ClinicalTrials.gov ID

NCT04988308

Sponsor

Janssen Research & Development, LLC

Study Description

  • Brief Summary:

    The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).

  • Condition or Disease:

    Hidradenitis Suppurativa

  • Intervention/Treatment:

    Drug: Bermekimab
    Drug: Adalimumab
    Drug: Bermekimab
    Drug: Bermekimab
    Drug: Bermekimab
    Drug: Bermekimab
    Drug: Bermekimab
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Have hidradenitis suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history
Have Hurley Stage II or Hurley Stage III HS as determined by the investigator at screening and baseline visits
Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold) at screening and baseline visits
Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=) 5 at the screening and baseline visit
Agree not to receive a live virus or live bacterial vaccination during the study and for 90 days after the last administration of study intervention

Exclusion Criteria:

Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has unstable cardiovascular disease, defined as a recent clinical deterioration (that is, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
Has or has had herpes zoster within the 2 months before screening
Has a transplanted organ (with exception of a corneal transplant greater than [>] 3 months before the first administration of study intervention)
Has known allergies, hypersensitivity, or intolerance to bermekimab or adalimumab or its excipients


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
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Australia

Participating Experts

Dr. Kim Alexander Papp

Dermatologist

Dr. Maryam Shayesteh Alam

Dermatologist

Dr. Shireen Sidhu

Dermatologist

Dr. Lynda Spelman

Dermatologist

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