Hidradenitis Suppurativa
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Hidradenitis Suppurativa
M20-262 Enrolling

Hidradenitis Suppurativa Clinical Research Trial (30 Weeks)


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.


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:

    AbbVie

  • 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,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.


Participating Locations


Participating Experts

Dr. Hermenio Lima

allergist,Dermatologist

Dr. Matthew Zirwas

Dermatologist

Dr. Marni Wiseman

Dermatologist

Dr. Susan Poelman

Dermatologist

Dr. Andrei Metelitsa

Dermatologist

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