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New hope for hidradenitis sufferers: experimental drug lutikizumab enters phase 2 trial

NCT ID NCT05139602

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests an investigational drug called lutikizumab (ABT-981) in about 210 adults with moderate to severe hidradenitis suppurativa (HS), a painful skin condition causing lumps and abscesses. The main study includes people who have already tried and failed anti-TNF therapy, while a sub-study includes those new to biologic treatments. Participants receive weekly injections of lutikizumab or a placebo for 16 weeks, with some continuing for up to 104 weeks in an extension phase. The goal is to see if the drug reduces skin lesions and pain better than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lutikizumab (ABT-981)
What this could lead to
If successful, this could provide a new treatment option for people with hidradenitis suppurativa who haven't responded to standard therapy.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. The drug may cause side effects or not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

210 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator. * A total abscess and inflammatory nodule (AN) count of \>= 5 at Baseline * HS lesions must be present in at least 2 distinct anatomic areas. * Must have failed anti-TNF treatment for HS. * To be eligible for the Sub-study, participants must be naïve to biologic therapy for treatment of HS. Exclusion Criteria: \- History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

Contacts and locations

Locations

  • 401 GSNA - 401 Army General Hospital /ID# 242189

    Athens, Attica, 11527, Greece

  • Advanced Dermatology of the Midlands /ID# 249750

    Omaha, Nebraska, 68144-1105, United States

  • Alma M. Cruz Santana, MD-Private practice /ID# 244514

    Carolina, 00985, Puerto Rico

  • Apex Clinical Trials /ID# 248558

    Brandon, Florida, 33511, United States

  • Beacon Dermatology Inc /ID# 240741

    Calgary, Alberta, T3A 2N1, Canada

  • Beth Israel Deaconess Medical Center /ID# 240683

    Boston, Massachusetts, 02215-5400, United States

  • Burke Pharmaceutical Research /ID# 240811

    Hot Springs, Arkansas, 71913-6404, United States

  • CCD Research, PLLC /ID# 240728

    Cromwell, Connecticut, 06416-1745, United States

  • Center for Clinical Studies - Houston (Binz) /ID# 240692

    Houston, Texas, 77004-8097, United States

  • Clinical Trials Research Institute /ID# 240642

    Thousand Oaks, California, 91320-2130, United States

  • Dawes Fretzin, LLC /ID# 240701

    Indianapolis, Indiana, 46256, United States

  • Dre Angelique Gagne-Henley M.D. inc. /ID# 240739

    Saint-Jérôme, Quebec, J7Z 7E2, Canada

  • Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385

    Stavroupoli (Thessalonikis), Thessaloniki, 55536, Greece

  • Duplicate_Paratus Clinical Research Woden /ID# 240605

    Phillip, Australian Capital Territory, 2606, Australia

  • Duplicate_Skin Specialists, PC /ID# 240804

    Omaha, Nebraska, 68144, United States

  • Duplicate_TruDerm Dermatology of Wellington /ID# 240780

    Wellington, Florida, 33449, United States

  • Duplicate_Universitaetsklinikum Erlangen /ID# 240872

    Erlangen, Bavaria, 91054, Germany

  • Duplicate_University General Hospital Attikon /ID# 240371

    Athens, Attica, 12462, Greece

  • Duplicate_University Hospital Kyoto Prefectural University of Medicine /ID# 244739

    Kyoto, Kyoto, 602-8566, Japan

  • Duplicate_University of the Ryukyus Hospital /ID# 244848

    Nakagami-gun, Okinawa, 903-0215, Japan

  • Essential Medical Research, LLC /ID# 241807

    Tulsa, Oklahoma, 74137-2842, United States

  • Florida International Rsrch cr /ID# 240902

    Miami, Florida, 33173, United States

  • Fukuoka University Hospital /ID# 244390

    Fukuoka, Fukuoka, 814-0180, Japan

  • GSI Clinical Research, LLC /ID# 240901

    Margate, Florida, 33063, United States

  • General Hospital Andreas Syggros /ID# 241104

    Athens, Attica, 16121, Greece

  • General Hospital of Thessaloniki Hippokrateio /ID# 240697

    Thessaloniki, 54642, Greece

  • Havelklinik /ID# 240874

    Berlin, 13595, Germany

  • Hospital General Universitario Gregorio Maranon /ID# 240396

    Madrid, 28007, Spain

  • Hospital Santa Creu i Sant Pau /ID# 240529

    Barcelona, 08041, Spain

  • Hospital Universitario Virgen de las Nieves /ID# 240429

    Granada, 18014, Spain

  • Hospital de Manises /ID# 240440

    Manises, Valencia, 46940, Spain

  • Kindai University Hospital /ID# 245358

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Klinikum Ruhr Univ Bochum /ID# 240870

    Bochum, 44791, Germany

  • Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814

    Hamilton, Ontario, L8L 3C3, Canada

  • Mayo Clinic - Scottsdale /ID# 241030

    Scottsdale, Arizona, 85259-5452, United States

  • Medderm Associates /ID# 240729

    San Diego, California, 92103, United States

  • MediSearch Clinical Trials /ID# 240810

    Saint Joseph, Missouri, 64506, United States

  • Medical Dermatology Specialists /ID# 240641

    Phoenix, Arizona, 85006, United States

  • Momentum Clinical Research /ID# 240911

    Darlinghurst, New South Wales, 2010, Australia

  • Montefiore Medical Center /ID# 240853

    The Bronx, New York, 10467, United States

  • Mount Sinai Doctors Dermatology /ID# 241588

    New York, New York, 10029-6504, United States

  • Nagoya City University Hospital /ID# 244392

    Nagoya, Aichi-ken, 467-8602, Japan

  • Park Avenue Dermatology, PA /ID# 240807

    Orange Park, Florida, 32073, United States

  • Premier Specialist /ID# 241288

    Kogarah, New South Wales, 2217, Australia

  • Revival Research Institute, LLC /ID# 241020

    Troy, Michigan, 48084-3536, United States

  • Ryan Clinical Research Inc /ID# 247986

    Newmarket, Ontario, L3Y 5G8, Canada

  • Schweiger Dermatology, P.C. /ID# 240900

    New York, New York, 07044-2946, United States

  • Skin Care Research Boca Raton /ID# 240758

    Boca Raton, Florida, 33486-2269, United States

  • Staedtisches Klinikum Dessau /ID# 240871

    Dessau, 06847, Germany

  • UCSF Fresno /ID# 240903

    Fresno, California, 93701-2302, United States

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 240873

    Hamburg, 20246, Germany

  • Veracity Clinical Research /ID# 241096

    Woolloongabba, Queensland, 4102, Australia

  • Washington University-School of Medicine /ID# 240797

    St Louis, Missouri, 63110, United States

  • Wiseman Dermatology Research /ID# 240738

    Winnipeg, Manitoba, R3M 3Z4, Canada

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