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

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05139602
• Other study ID #: M20-262
• Secondary ID: 2020-004108-33
• Status: Recruiting
• Phase: Phase 2
• Start date: December 28, 2021
• Est. completion date: January 24, 2026

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 24, 2026
• Est. primary completion date: January 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Biological:
• Lutikizumab
Subcutaneous Injection

Drug:
• Placebo
Subcutaneous Injection

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice /ID# 240911	Darlinghurst	New South Wales
Australia	Premier Specialist /ID# 241288	Kogarah	New South Wales
Australia	Duplicate_Paratus Clinical Research Woden /ID# 240605	Phillip	Australian Capital Territory
Australia	Veracity Clinical Research /ID# 241096	Woolloongabba	Queensland
Canada	Beacon Dermatology Inc /ID# 240741	Calgary	Alberta
Canada	Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814	Hamilton	Ontario
Canada	SKDS Research /ID# 247986	Newmarket	Ontario
Canada	Dre Angelique Gagne-Henley M.D. inc. /ID# 240739	Saint-Jerome	Quebec
Canada	Wiseman Dermatology Research /ID# 240738	Winnipeg	Manitoba
Germany	Havelklinik /ID# 240874	Berlin
Germany	Klinikum Ruhr Univ Bochum /ID# 240870	Bochum
Germany	Staedtisches Klinikum Dessau /ID# 240871	Dessau
Germany	Universitaetsklinikum Erlangen /ID# 240872	Erlangen	Bayern
Germany	Universitaetsklinikum Hamburg-Eppendorf /ID# 240873	Hamburg
Greece	401 GSNA - 401 Army General Hospital /ID# 242189	Athens	Attiki
Greece	General Hospital Andreas Syggros /ID# 241104	Athens	Attiki
Greece	University General Hospital Attikon /ID# 240371	Athens	Attiki
Greece	Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385	Stavroupoli (Thessalonikis)	Thessaloniki
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 240697	Thessaloniki
Japan	Fukuoka University Hospital /ID# 244390	Fukuoka-shi	Fukuoka
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 244739	Kyoto-shi	Kyoto
Japan	Nagoya City University Hospital /ID# 244392	Nagoya shi	Aichi
Japan	University of the Ryukyus Hospital /ID# 244848	Nakagami-gun	Okinawa
Japan	Kindai University Hospital /ID# 245358	Osakasayama-shi	Osaka
Puerto Rico	Alma M. Cruz Santana, MD-Private practice /ID# 244514	Carolina
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	Hospital de Manises /ID# 240440	Manises	Valencia
United States	Skin Care Research - Boca Raton /ID# 240758	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center /ID# 240683	Boston	Massachusetts
United States	Apex Clinical Trials /ID# 248558	Brandon	Florida
United States	Montefiore Medical Center /ID# 240853	Bronx	New York
United States	CCD Research, PLLC /ID# 240728	Cromwell	Connecticut
United States	Psoriasis Treatment Center of Central New Jersey /ID# 240900	East Windsor	New Jersey
United States	UCSF Fresno /ID# 240903	Fresno	California
United States	Burke Pharmaceutical Research /ID# 240811	Hot Springs	Arkansas
United States	Center for Clinical Studies - Houston (Binz) /ID# 240692	Houston	Texas
United States	Dawes Fretzin, LLC /ID# 240701	Indianapolis	Indiana
United States	GSI Clinical Research, LLC /ID# 240901	Margate	Florida
United States	Florida International Rsrch cr /ID# 240902	Miami	Florida
United States	Mount Sinai Doctors Dermatology /ID# 241588	New York	New York
United States	Advanced Dermatology of the Midlands /ID# 249750	Omaha	Nebraska
United States	Skin Specialists, PC /ID# 240804	Omaha	Nebraska
United States	Park Avenue Dermatology, PA /ID# 240807	Orange Park	Florida
United States	Medical Dermatology Specialists /ID# 240641	Phoenix	Arizona
United States	MediSearch Clinical Trials /ID# 240810	Saint Joseph	Missouri
United States	Washington University-School of Medicine /ID# 240797	Saint Louis	Missouri
United States	Medderm Associates /ID# 240729	San Diego	California
United States	Mayo Clinic - Scottsdale /ID# 241030	Scottsdale	Arizona
United States	Clinical Trials Research Institute /ID# 240642	Thousand Oaks	California
United States	Revival Research Institute, LLC /ID# 241020	Troy	Michigan
United States	Essential Medical Research, LLC /ID# 241807	Tulsa	Oklahoma
United States	TruDerm Dermatology of Wellington /ID# 240780	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External Links

•   Related Info