Acne Inversa Clinical Study (12 yrs+)

A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab (ABT-981) in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa,

Study Description

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.

Brief Summary

This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS .

Condition or Disease

Hidradenitis Suppruativa

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	1280
Primary Outcome Measures	Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response
Actual Study Start Date:	June 2024
Estimated Primary Completion Date:	December 2026

Eligibility Criteria

Ages Eligible for Study:	12 & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Hidradenitis Supurativa

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

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Moderate-to-Severe Hidradenitis Suppruativa Study (12 Years+)