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
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Drug: Placebo
- Registration Number
- NCT05139602
- Lead Sponsor
- AbbVie
- 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 receive 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Main Study: Lutikizumab Dose A Lutikizumab Lutikizumab Dose A every week Main Study: Lutikizumab Dose B Lutikizumab Lutikizumab Dose B every other week Main Study: Lutikizumab Dose C Lutikizumab Lutikizumab Dose C every other week Sub-study: Group 2 Lutikizumab Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week. Main Study: Placebo Placebo Placebo every week Sub-study: Group 1 Lutikizumab Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) Week 16 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.
Number of Participants with Adverse Events (AEs) Up to Approximately Week 68 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3 Week 16 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.
Trial Locations
- Locations (54)
Dr. S.K. Siddha Medicine Professional Corporation /ID# 247986
🇨🇦Newmarket, Ontario, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 240739
🇨🇦Saint-Jerome, Quebec, Canada
Momentum Clinical Research /ID# 240911
🇦🇺Darlinghurst, New South Wales, Australia
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
🇺🇸Saint 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
Montefiore Medical Center /ID# 240853
🇺🇸Bronx, New York, 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
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
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
Duplicate_Universitaetsklinikum Erlangen /ID# 240872
🇩🇪Erlangen, Bayern, Germany
Havelklinik /ID# 240874
🇩🇪Berlin, Germany
Klinikum Ruhr Univ Bochum /ID# 240870
🇩🇪Bochum, Germany
Staedtisches Klinikum Dessau /ID# 240871
🇩🇪Dessau, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 240873
🇩🇪Hamburg, Germany
401 GSNA - 401 Army General Hospital /ID# 242189
🇬🇷Athens, Attiki, Greece
Duplicate_University General Hospital Attikon /ID# 240371
🇬🇷Athens, Attiki, Greece
General Hospital Andreas Syggros /ID# 241104
🇬🇷Athens, Attiki, Greece
Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385
🇬🇷Stavroupoli (Thessalonikis), Thessaloniki, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 240697
🇬🇷Thessaloniki, Greece
Nagoya City University Hospital /ID# 244392
🇯🇵Nagoya shi, Aichi, Japan
Fukuoka University Hospital /ID# 244390
🇯🇵Fukuoka-shi, Fukuoka, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 244739
🇯🇵Kyoto-shi, 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
Hospital de Manises /ID# 240440
🇪🇸Manises, Valencia, Spain
Hospital Santa Creu i Sant Pau /ID# 240529
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de las Nieves /ID# 240429
🇪🇸Granada, Spain
Hospital General Universitario Gregorio Maranon /ID# 240396
🇪🇸Madrid, Spain