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

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 certain 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 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.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Placebo; Biological: Lutikizumab

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Completed
      • Duplicate_Paratus Clinical Research Woden /ID# 240605
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • Holdsworth House Medical Practice /ID# 240911
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • Premier Specialist /ID# 241288
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Veracity Clinical Research /ID# 241096
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
      • Recruiting
      • Beacon Dermatology Inc /ID# 240741
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Recruiting
      • Wiseman Dermatology Research /ID# 240738
  • Ontario
    • Hamilton, Ontario, Canada, L8L 3C3
      • Recruiting
      • Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Recruiting
      • SKDS Research /ID# 247986
  • Quebec
    • Saint-Jerome, Quebec, Canada, J7Z 7E2
      • Recruiting
      • Dre Angelique Gagne-Henley M.D. inc. /ID# 240739
• Germany
  • Berlin, Germany, 13595
    • Completed
    • Havelklinik /ID# 240874
  • Bochum, Germany, 44791
    • Completed
    • Klinikum Ruhr Univ Bochum /ID# 240870
  • Dessau, Germany, 06847
    • Completed
    • Staedtisches Klinikum Dessau /ID# 240871
  • Hamburg, Germany, 20246
    • Completed
    • Universitaetsklinikum Hamburg-Eppendorf /ID# 240873
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Completed
      • Universitaetsklinikum Erlangen /ID# 240872
• Greece
  • Thessaloniki, Greece, 54642
    • Completed
    • General Hospital of Thessaloniki Hippokrateio /ID# 240697
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Completed
      • 401 GSNA - 401 Army General Hospital /ID# 242189
    • Athens, Attiki, Greece, 12462
      • Completed
      • University General Hospital Attikon /ID# 240371
    • Athens, Attiki, Greece, 16121
      • Completed
      • General Hospital Andreas Syggros /ID# 241104
  • Thessaloniki
    • Stavroupoli (Thessalonikis), Thessaloniki, Greece, 55536
      • Completed
      • Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385
• Japan
  • Aichi
    • Nagoya shi, Aichi, Japan, 467-8602
      • Completed
      • Nagoya City University Hospital /ID# 244392
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Completed
      • Fukuoka University Hospital /ID# 244390
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 602-8566
      • Completed
      • University Hospital Kyoto Prefectural University of Medicine /ID# 244739
  • Okinawa
    • Nakagami-gun, Okinawa, Japan, 903-0215
      • Completed
      • University of the Ryukyus Hospital /ID# 244848
  • Osaka
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Completed
      • Kindai University Hospital /ID# 245358
• Puerto Rico
  • Carolina, Puerto Rico, 00985
    • Recruiting
    • Alma M. Cruz Santana, MD-Private practice /ID# 244514
• Spain
  • Barcelona, Spain, 08041
    • Completed
    • Hospital Santa Creu i Sant Pau /ID# 240529
  • Granada, Spain, 18014
    • Completed
    • Hospital Universitario Virgen de las Nieves /ID# 240429
  • Madrid, Spain, 28007
    • Completed
    • Hospital General Universitario Gregorio Maranon /ID# 240396
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Completed
      • Hospital de Manises /ID# 240440
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Medical Dermatology Specialists /ID# 240641
    • Scottsdale, Arizona, United States, 85259-5452
      • Recruiting
      • Mayo Clinic - Scottsdale /ID# 241030
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913-6404
      • Completed
      • Burke Pharmaceutical Research /ID# 240811
  • California
    • Fresno, California, United States, 93701-2302
      • Completed
      • UCSF Fresno /ID# 240903
    • San Diego, California, United States, 92103
      • Completed
      • Medderm Associates /ID# 240729
    • Thousand Oaks, California, United States, 91320-2130
      • Recruiting
      • Clinical Trials Research Institute /ID# 240642
  • Connecticut
    • Cromwell, Connecticut, United States, 06416-1745
      • Completed
      • CCD Research, PLLC /ID# 240728
  • Florida
    • Boca Raton, Florida, United States, 33486-2269
      • Recruiting
      • Skin Care Research - Boca Raton /ID# 240758
    • Brandon, Florida, United States, 33511
      • Recruiting
      • Apex Clinical Trials /ID# 248558
    • Margate, Florida, United States, 33063
      • Completed
      • GSI Clinical Research, LLC /ID# 240901
    • Miami, Florida, United States, 33173
      • Completed
      • Florida International Rsrch cr /ID# 240902
    • Orange Park, Florida, United States, 32073
      • Completed
      • Park Avenue Dermatology, PA /ID# 240807
    • Wellington, Florida, United States, 33449
      • Completed
      • TruDerm Dermatology of Wellington /ID# 240780
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Recruiting
      • Dawes Fretzin, LLC /ID# 240701
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5400
      • Recruiting
      • Beth Israel Deaconess Medical Center /ID# 240683
  • Michigan
    • Troy, Michigan, United States, 48084-3536
      • Completed
      • Revival Research Institute, LLC /ID# 241020
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Recruiting
      • MediSearch Clinical Trials /ID# 240810
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University-School of Medicine /ID# 240797
  • Nebraska
    • Omaha, Nebraska, United States, 68144-1105
      • Completed
      • Advanced Dermatology of the Midlands /ID# 249750
    • Omaha, Nebraska, United States, 68144
      • Completed
      • Skin Specialists, PC /ID# 240804
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Recruiting
      • Psoriasis Treatment Center of Central New Jersey /ID# 240900
  • New York
    • Bronx, New York, United States, 10467
      • Completed
      • Montefiore Medical Center /ID# 240853
    • New York, New York, United States, 10029-6504
      • Completed
      • Mount Sinai Doctors Dermatology /ID# 241588
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137-2842
      • Recruiting
      • Essential Medical Research, LLC /ID# 241807
  • Texas
    • Houston, Texas, United States, 77004-8097
      • Completed
      • Center for Clinical Studies - Houston (Binz) /ID# 240692

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main Study: Lutikizumab Dose A; Lutikizumab Dose A every week	Biological: Lutikizumab; Subcutaneous Injection; Other Names: ABT-981
Experimental: Main Study: Lutikizumab Dose B; Lutikizumab Dose B every other week	Biological: Lutikizumab; Subcutaneous Injection; Other Names: ABT-981
Experimental: Main Study: Lutikizumab Dose C; Lutikizumab Dose C every other week	Biological: Lutikizumab; Subcutaneous Injection; Other Names: ABT-981
Placebo Comparator: Main Study: Placebo; Placebo every week	Drug: Placebo; Subcutaneous Injection
Experimental: Sub-study: Group 1; Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.	Biological: Lutikizumab; Subcutaneous Injection; Other Names: ABT-981
Experimental: Sub-study: Group 2; Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.	Biological: Lutikizumab; Subcutaneous Injection; Other Names: ABT-981

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Estimated): January 24, 2026
• Study Completion (Estimated): January 24, 2026

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hidradenitis Suppurativa; Lutikizumab; ABT-981
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: M20-262; 2020-004108-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes