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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cahaba Dermatology & Skin Health Center /ID# 263795
  Birmingham, Alabama, United States Recruiting
• Medical Dermatology Specialists /ID# 263394
  Phoenix, Arizona, United States Recruiting
• Banner University Medicine Dermatology /ID# 263557
  Tucson, Arizona, United States Recruiting
• Dermatology Trial Associates /ID# 264587
  Bryant, Arkansas, United States Recruiting
• Arkansas Research Trials /ID# 263901
  North Little Rock, Arkansas, United States Recruiting
• Private Practice - Dr. Tooraj Raoof /ID# 263756
  Encino, California, United States Recruiting

+229 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessing molecular changes in adults with moderate to severe skin conditions receiving Lutikizumab

  This study is testing a new drug called Lutikizumab to see if it can help adults with moderate to severe skin conditions like hidradenitis suppurativa and atopic dermatitis feel better.

  Recruiting at 2 sites Phase 2 AbbVie · Sacramento, California and 1 other locations · NCT06524635

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• LAD328 in adults with hidradenitis suppurativa

  This study tests whether LAD328 works better than placebo for adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting Phase 2 Almirall, S.A. · Warsaw, Masovian Voivodeship · NCT07547813

• Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

  This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.

  Recruiting at 16 sites Novartis · Ancona, AN and 15 other locations · NCT07543419

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.