Clinical trial NCT05139602: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Lutikizumab
ABT-981
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)
timeFrame: Week 16
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Approximately Week 68
Secondary outcomes:
measure: Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
timeFrame: Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists /ID# 240641
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale /ID# 241030
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research /ID# 240811
state: Arkansas
city: Fresno
country: United States
facility: UCSF Fresno /ID# 240903
state: California
city: San Diego
country: United States
facility: Medderm Associates /ID# 240729
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute /ID# 240642
state: California
city: Cromwell
country: United States
facility: CCD Research, PLLC /ID# 240728
state: Connecticut
city: Boca Raton
country: United States
facility: Skin Care Research Boca Raton /ID# 240758
state: Florida
city: Brandon
country: United States
facility: Apex Clinical Trials /ID# 248558
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC /ID# 240901
state: Florida
city: Miami
country: United States
facility: Florida International Rsrch cr /ID# 240902
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA /ID# 240807
state: Florida
city: Wellington
country: United States
facility: TruDerm Dermatology of Wellington /ID# 240780
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 240701
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 240683
state: Massachusetts
city: Troy
country: United States
facility: Revival Research Institute, LLC /ID# 241020
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials /ID# 240810
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 240797
state: Missouri
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands /ID# 249750
state: Nebraska
city: Omaha
country: United States
facility: Duplicate_Skin Specialists, PC /ID# 240804
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center /ID# 240853
state: New York
city: New York
country: United States
facility: Schweiger Dermatology, P.C. /ID# 240900
state: New York
city: New York
country: United States
facility: Mount Sinai Doctors Dermatology /ID# 241588
state: New York
city: Tulsa
country: United States
facility: Essential Medical Research, LLC /ID# 241807
state: Oklahoma
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 240692
state: Texas
city: Phillip
country: Australia
facility: Duplicate_Paratus Clinical Research Woden /ID# 240605
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: Momentum Clinical Research /ID# 240911
state: New South Wales
city: Kogarah
country: Australia
facility: Premier Specialist /ID# 241288
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research /ID# 241096
state: Queensland
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 240741
state: Alberta
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 240738
state: Manitoba
city: Hamilton
country: Canada
facility: Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814
state: Ontario
city: Newmarket
country: Canada
facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 247986
state: Ontario
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 240739
state: Quebec
city: Erlangen
country: Germany
facility: Duplicate_Universitaetsklinikum Erlangen /ID# 240872
state: Bayern
city: Berlin
country: Germany
facility: Havelklinik /ID# 240874
city: Bochum
country: Germany
facility: Klinikum Ruhr Univ Bochum /ID# 240870
city: Dessau
country: Germany
facility: Staedtisches Klinikum Dessau /ID# 240871
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf /ID# 240873
city: Athens
country: Greece
facility: 401 GSNA - 401 Army General Hospital /ID# 242189
state: Attiki
city: Athens
country: Greece
facility: Duplicate_University General Hospital Attikon /ID# 240371
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 241104
state: Attiki
city: Stavroupoli (Thessalonikis)
country: Greece
facility: Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385
state: Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokrateio /ID# 240697
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 244392
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 244390
state: Fukuoka
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 244739
state: Kyoto
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital /ID# 244848
state: Okinawa
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 245358
state: Osaka
city: Carolina
country: Puerto Rico
facility: Alma M. Cruz Santana, MD-Private practice /ID# 244514
city: Manises
country: Spain
facility: Hospital de Manises /ID# 240440
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 240529
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 240429
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 240396
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: