🏛️ Verified NIH Record • Updated 2026-02-11

A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy (NCT05139602)

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: Amended Protocol to Include a Lutikizumab Open-Label Sub-study in Subjects Naïve to Biologic Therapy

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: AbbVie

🩺 Plain-English Summary (8th-Grade Level)

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 armpits, inner thighs, groin and buttocks. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy. Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. In the Main Study, participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide. In the Sub-study, participants will be put in 1 of 2 groups, called treatment arms. Both arms will receive treatment at different dosing intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic therapy will be enrolled in the study at approximately 20 sites. In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week or every other week for 36 weeks. There will be an optional Long Term Extension (LTE) for participants who completed Week 52 of the Sub-study and, as confirmed by the investigator, have shown a therapeutic benefit to study drug. Participants would then received lutikizumab using the same assigned dosing regimen as that from Period 2 of the Sub-study for an additional 104 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.

Who can join: Review the eligibility criteria below.

Location: Medical Dermatology Specialists /ID# 240641 — Phoenix, Arizona

Age range: 18 Years

🧪 Interventions in This Study

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Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (54 Sites)

Showing the first 25 of 54 sites.

  • Medical Dermatology Specialists /ID# 240641 — Phoenix, Arizona
  • Mayo Clinic - Scottsdale /ID# 241030 — Scottsdale, Arizona
  • Burke Pharmaceutical Research /ID# 240811 — Hot Springs, Arkansas
  • UCSF Fresno /ID# 240903 — Fresno, California
  • Medderm Associates /ID# 240729 — San Diego, California
  • Clinical Trials Research Institute /ID# 240642 — Thousand Oaks, California
  • CCD Research, PLLC /ID# 240728 — Cromwell, Connecticut
  • Skin Care Research Boca Raton /ID# 240758 — Boca Raton, Florida
  • Apex Clinical Trials /ID# 248558 — Brandon, Florida
  • GSI Clinical Research, LLC /ID# 240901 — Margate, Florida
  • Florida International Rsrch cr /ID# 240902 — Miami, Florida
  • Park Avenue Dermatology, PA /ID# 240807 — Orange Park, Florida
  • Duplicate_TruDerm Dermatology of Wellington /ID# 240780 — Wellington, Florida
  • Dawes Fretzin, LLC /ID# 240701 — Indianapolis, Indiana
  • Beth Israel Deaconess Medical Center /ID# 240683 — Boston, Massachusetts
  • Revival Research Institute, LLC /ID# 241020 — Troy, Michigan
  • MediSearch Clinical Trials /ID# 240810 — Saint Joseph, Missouri
  • Washington University-School of Medicine /ID# 240797 — St Louis, Missouri
  • Advanced Dermatology of the Midlands /ID# 249750 — Omaha, Nebraska
  • Duplicate_Skin Specialists, PC /ID# 240804 — Omaha, Nebraska
  • Schweiger Dermatology, P.C. /ID# 240900 — New York, New York
  • Mount Sinai Doctors Dermatology /ID# 241588 — New York, New York
  • Montefiore Medical Center /ID# 240853 — The Bronx, New York
  • Essential Medical Research, LLC /ID# 241807 — Tulsa, Oklahoma
  • Center for Clinical Studies - Houston (Binz) /ID# 240692 — Houston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Hidradenitis Suppurativa clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗