Hidradenitis Suppurativa
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Hidradenitis Suppurativa
M20-262 Enrolling

Hidradenitis Suppurativa Clinical Research Trial (30 Weeks)


Treatment: Injection Age: 18 Years

Adults at least 18 years of age with a diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline, may qualify to participate. Qualified participants must have a total abscess and inflammatory nodule (AN) count of 5 or more, and HS lesions present in at least 2 distinct anatomic areas. In addition, participants must have no history of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g. bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.

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

Study participation will last about 30 weeks and involve about 13 visits to the study centre, plus a follow-up phone call.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Phase 2 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lutikizumab (ABT-981) in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

ClinicalTrials.gov ID

NCT05139602

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. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy. Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. Participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide. Participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 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:

    Biological: Lutikizumab
    Biological: Lutikizumab
    Biological: Lutikizumab
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

A clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator.
A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline
HS lesions must be present in at least 2 distinct anatomic areas.
Must have failed anti-TNF treatment for HS.

Exclusion Criteria:

– History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.


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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United States
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Australia

Participating Experts

Dr. Sanjay Siddha

Dermatologist

Dr. Hermenio Lima

allergist,Dermatologist

Dr. Matthew Zirwas

Dermatologist

Dr. Marni Wiseman

Dermatologist

Dr. Susan Poelman

Dermatologist

Dr. Andrei Metelitsa

Dermatologist

Dr. Lynda Spelman

Dermatologist

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