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Hidradenitis SuppurativaPhase 2NCT05139602

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

A Phase 2 study testing Lutikizumab in people with Hidradenitis Suppurativa, run by AbbVie at 54 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Lutikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
54 sitesin 8 countries
Study dates
28 Dec 2021to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

54 sites in 8 countries.

54 sites in 8 countries

United States25 sites

  • Skin Care Research Boca Raton /ID# 240758

    Boca Raton, Florida, 33486-2269

  • Beth Israel Deaconess Medical Center /ID# 240683

    Boston, Massachusetts, 02215-5400

  • Apex Clinical Trials /ID# 248558

    Brandon, Florida, 33511

  • CCD Research, PLLC /ID# 240728

    Cromwell, Connecticut, 06416-1745

  • UCSF Fresno /ID# 240903

    Fresno, California, 93701-2302

  • Burke Pharmaceutical Research /ID# 240811

    Hot Springs, Arkansas, 71913-6404

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

    Houston, Texas, 77004-8097

  • Dawes Fretzin, LLC /ID# 240701

    Indianapolis, Indiana, 46256

  • GSI Clinical Research, LLC /ID# 240901

    Margate, Florida, 33063

  • Florida International Rsrch cr /ID# 240902

    Miami, Florida, 33173

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

    New York, New York, 07044-2946

  • Mount Sinai Doctors Dermatology /ID# 241588

    New York, New York, 10029-6504

  • Advanced Dermatology of the Midlands /ID# 249750

    Omaha, Nebraska, 68144-1105

  • Duplicate_Skin Specialists, PC /ID# 240804

    Omaha, Nebraska, 68144

  • Park Avenue Dermatology, PA /ID# 240807

    Orange Park, Florida, 32073

  • Medical Dermatology Specialists /ID# 240641

    Phoenix, Arizona, 85006

  • MediSearch Clinical Trials /ID# 240810

    Saint Joseph, Missouri, 64506

  • Medderm Associates /ID# 240729

    San Diego, California, 92103

  • Mayo Clinic - Scottsdale /ID# 241030

    Scottsdale, Arizona, 85259-5452

  • Washington University-School of Medicine /ID# 240797

    St Louis, Missouri, 63110

  • Montefiore Medical Center /ID# 240853

    The Bronx, New York, 10467

  • Clinical Trials Research Institute /ID# 240642

    Thousand Oaks, California, 91320-2130

  • Revival Research Institute, LLC /ID# 241020

    Troy, Michigan, 48084-3536

  • Essential Medical Research, LLC /ID# 241807

    Tulsa, Oklahoma, 74137-2842

  • Duplicate_TruDerm Dermatology of Wellington /ID# 240780

    Wellington, Florida, 33449

Other trials in United States

Canada5 sites

  • Beacon Dermatology Inc /ID# 240741

    Calgary, Alberta, T3A 2N1

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

    Hamilton, Ontario, L8L 3C3

  • Ryan Clinical Research Inc /ID# 247986

    Newmarket, Ontario, L3Y 5G8

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

    Saint-Jérôme, Quebec, J7Z 7E2

  • Wiseman Dermatology Research /ID# 240738

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Germany5 sites

  • Havelklinik /ID# 240874

    Berlin, 13595

  • Klinikum Ruhr Univ Bochum /ID# 240870

    Bochum, 44791

  • Staedtisches Klinikum Dessau /ID# 240871

    Dessau, 06847

  • Duplicate_Universitaetsklinikum Erlangen /ID# 240872

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 240873

    Hamburg, 20246

Other trials in Germany

Greece5 sites

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

    Athens, Attica, 11527

  • Duplicate_University General Hospital Attikon /ID# 240371

    Athens, Attica, 12462

  • General Hospital Andreas Syggros /ID# 241104

    Athens, Attica, 16121

  • Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385

    Stavroupoli (Thessalonikis), Thessaloniki, 55536

  • General Hospital of Thessaloniki Hippokrateio /ID# 240697

    Thessaloniki, 54642

Other trials in Greece

Japan5 sites

  • Fukuoka University Hospital /ID# 244390

    Fukuoka, Fukuoka, 814-0180

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

    Kyoto, Kyoto, 602-8566

  • Nagoya City University Hospital /ID# 244392

    Nagoya, Aichi-ken, 467-8602

  • Duplicate_University of the Ryukyus Hospital /ID# 244848

    Nakagami-gun, Okinawa, 903-0215

  • Kindai University Hospital /ID# 245358

    Osakasayama-shi, Osaka, 589-8511

Other trials in Japan

Australia4 sites

  • Momentum Clinical Research /ID# 240911

    Darlinghurst, New South Wales, 2010

  • Premier Specialist /ID# 241288

    Kogarah, New South Wales, 2217

  • Duplicate_Paratus Clinical Research Woden /ID# 240605

    Phillip, Australian Capital Territory, 2606

  • Veracity Clinical Research /ID# 241096

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain4 sites

  • Hospital Santa Creu i Sant Pau /ID# 240529

    Barcelona, 08041

  • Hospital Universitario Virgen de las Nieves /ID# 240429

    Granada, 18014

  • Hospital General Universitario Gregorio Maranon /ID# 240396

    Madrid, 28007

  • Hospital de Manises /ID# 240440

    Manises, Valencia, 46940

Other trials in Spain

Puerto Rico1 site

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

    Carolina, 00985

Other trials in Puerto Rico

About this study

Official title: 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

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.

Read more

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.

Being tested
Lutikizumab, Placebo
Keywords
Hidradenitis Suppurativa, Lutikizumab, ABT-981
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LutikizumabBiological

    Also called ABT-981

    Subcutaneous Injection

  • PlaceboDrug

    Subcutaneous Injection

Study groups in NCT05139602
Study groupRoleWhat they receive
Main Study: Lutikizumab Dose AExperimentalLutikizumab Dose A every week
Receives: Biological: Lutikizumab
Main Study: Lutikizumab Dose BExperimentalLutikizumab Dose B every other week
Receives: Biological: Lutikizumab
Main Study: Lutikizumab Dose CExperimentalLutikizumab Dose C every other week
Receives: Biological: Lutikizumab
Main Study: PlaceboPlacebo comparatorPlacebo every week
Receives: Drug: Placebo
Sub-study: Group 1ExperimentalPeriod 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.
Receives: Biological: Lutikizumab
Sub-study: Group 2ExperimentalPeriod 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.
Receives: Biological: Lutikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)

    HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula-count relative to Baseline.

    Measured: Week 16

  2. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately Week 68

Secondary outcomes (1)

  1. Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3

    NRS 30 is defined as at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain), as assessed by the Patient's Global Assessment (PGA) of Skin Pain.

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start28 Dec 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05139602
Sponsor's protocol ID
M20-262
Other IDs
2020-004108-33
Status last verified
Feb 2026
First submitted
29 Nov 2021
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Kimball AB, Sawicki KT, Ackerman L, Lima H, Giamarellos-Bourboulis EJ, Zhan T, Drogaris L, Gu Y, Lee CM, Akbari M, Williams DA, Bechara FG. Lutikizumab in Adults With Moderate to Severe Hidradenitis Suppurativa After Anti-TNF Therapy Failure: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2026 May 1;162(5):469-477. doi: 10.1001/jamadermatol.2026.0155.

    PubMed 41848710

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutikizumab in people with Hidradenitis Suppurativa, run by AbbVie at 54 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Canada, Germany, Greece, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05139602, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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