Status:
RECRUITING
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Lead Sponsor:
AbbVie
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 ar...
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant).
- Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
- Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.
- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
Exclusion Criteria:
- Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Confirmed positive anti-HIV antibody (HIV Ab) test.
- Evidence of active tuberculosis or meets tuberculosis exclusionary parameter
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1280 Patients enrolled
Trial Details
Trial ID
NCT06468228
Start Date
June 27 2024
End Date
December 1 2026
Last Update
March 20 2026
Active Locations (279)
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1
Cahaba Dermatology & Skin Health Center /ID# 263795
Birmingham, Alabama, United States, 35244
2
Medical Dermatology Specialists /ID# 263394
Phoenix, Arizona, United States, 85006
3
Banner University Medicine Dermatology /ID# 263557
Tucson, Arizona, United States, 85718-1407
4
Dermatology Trial Associates /ID# 264587
Bryant, Arkansas, United States, 72022