Hidradenitis Suppurativa
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Hidradenitis Suppurativa
M20-465 Enrolling

Clinical Trial for Hidradenitis Suppurativa (67 Weeks)


Treatment: Injection Age: 16 Years


Who Can Participate?

People aged 16 and above diagnosed with hidradenitis suppurativa (HS) may participate.

Inclusion Criteria

  • A clinical diagnosis of moderate to severe HS for at least 6 months
  • Have the presence of HS lesions in at least 2 distinct anatomic areas
  • Intolerance to oral antibiotics for HS treatment

What Are The Benefits?

  • No cost to participate or receive treatment
  • Regular visits with study doctors who specialize in treating HS (20 visits)
  • Will receive either an investigative injection or a placebo

How Long Will The Study Last?

  • Around 67 weeks

Participating Locations

COUNTRY
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United States

Participating Experts

Dr. Matthew Zirwas

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: June 27, 2024

Official Title

A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa

ClinicalTrials.gov ID

NCT06468228

Sponsor

AbbVie

Study Description

  • Brief Summary:

    Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.

  • Condition or Disease:

    Hidradenitis Suppurativa

  • Intervention/Treatment:

    Drug: Lutikizumab,Drug: Placebo Drug: Lutikizumab Drug: Lutikizumab,Drug: Placebo Drug: Lutikizumab Drug: Lutikizumab Drug: Lutikizumab,Drug: Placebo
  • Phase:

    PHASE3

  • Ages Eligible for Study:

    16 Years and older (CHILD,ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL

Inclusion Criteria

  • A clinical diagnosis of moderate to severe HS for at least 6 months
  • Have the presence of HS lesions in at least 2 distinct anatomic areas
  • Intolerance to oral antibiotics for HS treatment

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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