Hidradenitis Suppurativa
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Hidradenitis Suppurativa
18518 Enrolling

Clinical Trial for Adults with Hidradenitis Suppurativa


Treatment: Injection Age: 18 Years


Who can participate?

Open enrollment for adults aged 18 to 75, inclusive, with Hidradenitis Suppurativa (HS).

Inclusion Criteria:

  • Have a diagnosis of HS for at least 12 months before randomization (visit 2). *
  • Have HS lesions in at least 2 distinct anatomical regions.
  • Had an inadequate response or intolerance to a 28-day course of oral antibiotics at any time before screening.
  • Have a total abscess and inflammatory nodule count greater than or equal to 5.

*Note: a participant with clinical history of HS may be considered if other eligibility criteria are met and if the investigator documents the clinical history based on the review of medical history at screening

What are the benefits?

As a participation in our research trial, you will receive an investigational treatment (active study drug) or placebo via injection combined with topical, entirely free of cost. All study-related assessments will also be provided at no charge. In addition, you may also be eligible for reimbursement of study-related expenses.

How long will the study last?

62 weeks and involves frequent visits to the study centre.


Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Kurt Gebauer

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: June 23, 2024

Official Title

A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

ClinicalTrials.gov ID

NCT06046729

Sponsor

Eli Lilly and Company

Study Description

  • Brief Summary:

    This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.

  • Condition or Disease:

    Hidradenitis Suppurativa

  • Intervention/Treatment:

    Drug: Eltrekibart
    Drug: Eltrekibart
    Drug: Eltrekibart
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Have a diagnosis of HS for at least 12 months.
Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.
Have an (abscess plus inflammatory nodule) count of at least 5.
Agree to use topical antiseptics daily.
Had an inadequate response or intolerance to a 28-day course of oral antibiotics.

Exclusion Criteria:

Have more than 20 draining fistulae.
Have had surgical treatment for HS in the last 4 weeks before randomization.
Have an active skin disease or condition, that could interfere with the assessment of HS.
Have a current or recent acute, active infection.
Are immunocompromised.
Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year 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.



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