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

NCT ID: NCT05139602

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2026-01-31

Brief 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. 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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Main Study: Lutikizumab Dose A

Lutikizumab Dose A every week

Group Type: EXPERIMENTAL

Lutikizumab

Intervention Type: BIOLOGICAL

Subcutaneous Injection

Main Study: Lutikizumab Dose B

Lutikizumab Dose B every other week

Group Type: EXPERIMENTAL

Lutikizumab

Intervention Type: BIOLOGICAL

Subcutaneous Injection

Main Study: Lutikizumab Dose C

Lutikizumab Dose C every other week

Group Type: EXPERIMENTAL

Lutikizumab

Intervention Type: BIOLOGICAL

Subcutaneous Injection

Main Study: Placebo

Placebo every week

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous Injection

Sub-study: Group 1

Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.

Group Type: EXPERIMENTAL

Lutikizumab

Intervention Type: BIOLOGICAL

Subcutaneous Injection

Sub-study: Group 2

Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.

Group Type: EXPERIMENTAL

Lutikizumab

Intervention Type: BIOLOGICAL

Subcutaneous Injection

Interventions

Lutikizumab

Subcutaneous Injection

Intervention Type: BIOLOGICAL

Placebo

Subcutaneous Injection

Intervention Type: DRUG

Other Intervention Names

ABT-981

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Medical Dermatology Specialists /ID# 240641

Phoenix, Arizona, United States

Mayo Clinic - Scottsdale /ID# 241030

Scottsdale, Arizona, United States

Burke Pharmaceutical Research /ID# 240811

Hot Springs, Arkansas, United States

UCSF Fresno /ID# 240903

Fresno, California, United States

Medderm Associates /ID# 240729

San Diego, California, United States

Clinical Trials Research Institute /ID# 240642

Thousand Oaks, California, United States

CCD Research, PLLC /ID# 240728

Cromwell, Connecticut, United States

Skin Care Research Boca Raton /ID# 240758

Boca Raton, Florida, United States

Apex Clinical Trials /ID# 248558

Brandon, Florida, United States

GSI Clinical Research, LLC /ID# 240901

Margate, Florida, United States

Florida International Rsrch cr /ID# 240902

Miami, Florida, United States

Park Avenue Dermatology, PA /ID# 240807

Orange Park, Florida, United States

TruDerm Dermatology of Wellington /ID# 240780

Wellington, Florida, United States

Dawes Fretzin, LLC /ID# 240701

Indianapolis, Indiana, United States

Beth Israel Deaconess Medical Center /ID# 240683

Boston, Massachusetts, United States

Revival Research Institute, LLC /ID# 241020

Troy, Michigan, United States

MediSearch Clinical Trials /ID# 240810

Saint Joseph, Missouri, United States

Washington University-School of Medicine /ID# 240797

St Louis, Missouri, United States

Advanced Dermatology of the Midlands /ID# 249750

Omaha, Nebraska, United States

Duplicate_Skin Specialists, PC /ID# 240804

Omaha, Nebraska, United States

Schweiger Dermatology, P.C. /ID# 240900

New York, New York, United States

Mount Sinai Doctors Dermatology /ID# 241588

New York, New York, United States

Montefiore Medical Center /ID# 240853

The Bronx, New York, United States

Essential Medical Research, LLC /ID# 241807

Tulsa, Oklahoma, United States

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

Houston, Texas, United States

Duplicate_Paratus Clinical Research Woden /ID# 240605

Phillip, Australian Capital Territory, Australia

Momentum Clinical Research /ID# 240911

Darlinghurst, New South Wales, Australia

Premier Specialist /ID# 241288

Kogarah, New South Wales, Australia

Veracity Clinical Research /ID# 241096

Woolloongabba, Queensland, Australia

Beacon Dermatology Inc /ID# 240741

Calgary, Alberta, Canada

Wiseman Dermatology Research /ID# 240738

Winnipeg, Manitoba, Canada

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

Hamilton, Ontario, Canada

Dr. S.K. Siddha Medicine Professional Corporation /ID# 247986

Newmarket, Ontario, Canada

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

Saint-Jérôme, Quebec, Canada

Duplicate_Universitaetsklinikum Erlangen /ID# 240872

Erlangen, Bavaria, Germany

Universitaetsklinikum Hamburg-Eppendorf /ID# 240873

Hamburg, City state of Hamburg, Germany

Havelklinik /ID# 240874

Berlin, State of Berlin, Germany

Klinikum Ruhr Univ Bochum /ID# 240870

Bochum, , Germany

Staedtisches Klinikum Dessau /ID# 240871

Dessau, , Germany

401 GSNA - 401 Army General Hospital /ID# 242189

Athens, Attica, Greece

Duplicate_University General Hospital Attikon /ID# 240371

Athens, Attica, Greece

General Hospital Andreas Syggros /ID# 241104

Athens, Attica, Greece

Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385

Stavroupoli (Thessalonikis), Thessaloniki, Greece

General Hospital of Thessaloniki Hippokrateio /ID# 240697

Thessaloniki, Thessaloniki, Greece

Nagoya City University Hospital /ID# 244392

Nagoya, Aichi-ken, Japan

Fukuoka University Hospital /ID# 244390

Fukuoka, Fukuoka, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 244739

Kyoto, Kyoto, Japan

University of the Ryukyus Hospital /ID# 244848

Nakagami-gun, Okinawa, Japan

Kindai University Hospital /ID# 245358

Osakasayama-shi, Osaka, Japan

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

Carolina, Puerto Rico, Puerto Rico

Hospital Santa Creu i Sant Pau /ID# 240529

Barcelona, Barcelona, Spain

Hospital Universitario Virgen de las Nieves /ID# 240429

Granada, Granada, Spain

Hospital General Universitario Gregorio Maranon /ID# 240396

Madrid, Madrid, Spain

Hospital de Manises /ID# 240440

Manises, Valencia, Spain

Countries

United States; Australia; Canada; Germany; Greece; Japan; Puerto Rico; Spain

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M20-262

Related Info

Other Identifiers

2020-004108-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M20-262

Identifier Type: -

Identifier Source: org_study_id