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Assessing the safety and effectiveness of lutikizumab for treating moderate to severe hidradenitis suppurativa

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

Phase 3 Interventional AbbVie · NCT06468228

This study is testing a new drug called lutikizumab to see if it can safely help adults and teens with moderate to severe hidradenitis suppurativa feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1280 (estimated)
Ages12 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionslutikizumab
Locations279 sites (Birmingham, Alabama and 278 other locations)
Trial IDNCT06468228 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of lutikizumab, an investigational drug, in treating adult and adolescent patients with moderate to severe hidradenitis suppurativa (HS). Participants will be randomly assigned to receive either lutikizumab or a placebo in a 1:1 ratio. The study aims to enroll approximately 1280 participants across 275 sites globally, with a focus on measuring disease activity and safety outcomes. Following an initial treatment period, participants receiving lutikizumab will be re-randomized for further assessment.

Who should consider this trial

Good fit: Ideal candidates are adults and adolescents diagnosed with moderate to severe hidradenitis suppurativa for at least six months.

Not a fit: Patients with active infections such as hepatitis B, hepatitis C, or HIV, or those with active tuberculosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from moderate to severe hidradenitis suppurativa.

How similar studies have performed: Previous studies have shown promise in treating hidradenitis suppurativa with similar biologic therapies, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 278 other locations

+229 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis Suppurativa
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.