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 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
2 other identifiers
interventional
210
8 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2021
Longer than P75 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
December 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 13, 2026
February 1, 2026
5.9 years
November 29, 2021
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Week 16
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.
Up to Approximately Week 68
Secondary Outcomes (1)
Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
Week 16
Study Arms (6)
Main Study: Lutikizumab Dose A
EXPERIMENTALLutikizumab Dose A every week
Main Study: Lutikizumab Dose B
EXPERIMENTALLutikizumab Dose B every other week
Main Study: Lutikizumab Dose C
EXPERIMENTALLutikizumab Dose C every other week
Main Study: Placebo
PLACEBO COMPARATORPlacebo every week
Sub-study: Group 1
EXPERIMENTALPeriod 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.
Sub-study: Group 2
EXPERIMENTALPeriod 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.
Interventions
Subcutaneous Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (54)
Medical Dermatology Specialists /ID# 240641
Phoenix, Arizona, 85006, United States
Mayo Clinic - Scottsdale /ID# 241030
Scottsdale, Arizona, 85259-5452, United States
Burke Pharmaceutical Research /ID# 240811
Hot Springs, Arkansas, 71913-6404, United States
UCSF Fresno /ID# 240903
Fresno, California, 93701-2302, United States
Medderm Associates /ID# 240729
San Diego, California, 92103, United States
Clinical Trials Research Institute /ID# 240642
Thousand Oaks, California, 91320-2130, United States
CCD Research, PLLC /ID# 240728
Cromwell, Connecticut, 06416-1745, United States
Skin Care Research Boca Raton /ID# 240758
Boca Raton, Florida, 33486-2269, United States
Apex Clinical Trials /ID# 248558
Brandon, Florida, 33511, United States
GSI Clinical Research, LLC /ID# 240901
Margate, Florida, 33063, United States
Florida International Rsrch cr /ID# 240902
Miami, Florida, 33173, United States
Park Avenue Dermatology, PA /ID# 240807
Orange Park, Florida, 32073, United States
Duplicate_TruDerm Dermatology of Wellington /ID# 240780
Wellington, Florida, 33449, United States
Dawes Fretzin, LLC /ID# 240701
Indianapolis, Indiana, 46256, United States
Beth Israel Deaconess Medical Center /ID# 240683
Boston, Massachusetts, 02215-5400, United States
Revival Research Institute, LLC /ID# 241020
Troy, Michigan, 48084-3536, United States
MediSearch Clinical Trials /ID# 240810
Saint Joseph, Missouri, 64506, United States
Washington University-School of Medicine /ID# 240797
St Louis, Missouri, 63110, United States
Advanced Dermatology of the Midlands /ID# 249750
Omaha, Nebraska, 68144-1105, United States
Duplicate_Skin Specialists, PC /ID# 240804
Omaha, Nebraska, 68144, United States
Schweiger Dermatology, P.C. /ID# 240900
New York, New York, 07044-2946, United States
Mount Sinai Doctors Dermatology /ID# 241588
New York, New York, 10029-6504, United States
Montefiore Medical Center /ID# 240853
The Bronx, New York, 10467, United States
Essential Medical Research, LLC /ID# 241807
Tulsa, Oklahoma, 74137-2842, United States
Center for Clinical Studies - Houston (Binz) /ID# 240692
Houston, Texas, 77004-8097, United States
Duplicate_Paratus Clinical Research Woden /ID# 240605
Phillip, Australian Capital Territory, 2606, Australia
Momentum Clinical Research /ID# 240911
Darlinghurst, New South Wales, 2010, Australia
Premier Specialist /ID# 241288
Kogarah, New South Wales, 2217, Australia
Veracity Clinical Research /ID# 241096
Woolloongabba, Queensland, 4102, Australia
Beacon Dermatology Inc /ID# 240741
Calgary, Alberta, T3A 2N1, Canada
Wiseman Dermatology Research /ID# 240738
Winnipeg, Manitoba, R3M 3Z4, Canada
Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814
Hamilton, Ontario, L8L 3C3, Canada
Ryan Clinical Research Inc /ID# 247986
Newmarket, Ontario, L3Y 5G8, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 240739
Saint-Jérôme, Quebec, J7Z 7E2, Canada
Duplicate_Universitaetsklinikum Erlangen /ID# 240872
Erlangen, Bavaria, 91054, Germany
Havelklinik /ID# 240874
Berlin, 13595, Germany
Klinikum Ruhr Univ Bochum /ID# 240870
Bochum, 44791, Germany
Staedtisches Klinikum Dessau /ID# 240871
Dessau, 06847, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 240873
Hamburg, 20246, Germany
401 GSNA - 401 Army General Hospital /ID# 242189
Athens, Attica, 11527, Greece
Duplicate_University General Hospital Attikon /ID# 240371
Athens, Attica, 12462, Greece
General Hospital Andreas Syggros /ID# 241104
Athens, Attica, 16121, Greece
Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385
Stavroupoli (Thessalonikis), Thessaloniki, 55536, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 240697
Thessaloniki, 54642, Greece
Nagoya City University Hospital /ID# 244392
Nagoya, Aichi-ken, 467-8602, Japan
Fukuoka University Hospital /ID# 244390
Fukuoka, Fukuoka, 814-0180, Japan
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
Kindai University Hospital /ID# 245358
Osakasayama-shi, Osaka, 589-8511, Japan
Alma M. Cruz Santana, MD-Private practice /ID# 244514
Carolina, 00985, Puerto Rico
Hospital de Manises /ID# 240440
Manises, Valencia, 46940, Spain
Hospital Santa Creu i Sant Pau /ID# 240529
Barcelona, 08041, Spain
Hospital Universitario Virgen de las Nieves /ID# 240429
Granada, 18014, Spain
Hospital General Universitario Gregorio Maranon /ID# 240396
Madrid, 28007, Spain
Related Publications (1)
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 Mar 18. doi: 10.1001/jamadermatol.2026.0155. Online ahead of print.
PMID: 41848710DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 1, 2021
Study Start
December 28, 2021
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.