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Active, not recruitingPhase 2

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

Key facts

Who runs it
AbbVie
Where
Boca Raton, Boston, Brandon, Cromwell, Fresno, Hot Springs, Houston, Indianapolis, Margate, Miami, New York, Omaha, Orange Park, Phoenix, Saint Joseph, San Diego, Scottsdale, St Louis, The Bronx, Thousand Oaks, Troy, Tulsa, and Wellington, United StatesSee the 25 sitesAlso in 7 other countries, 29 sites
Status
Active, not recruiting
Phase
Phase 2
People taking part
210 people enrolled
Started
28 Dec 2021
Expected to end
Dec 2027
Type of study
Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Lutikizumab
  • Placebo
Record updated
13 February 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in United States

Also in 7 other countries, 29 sites

  • Skin Care Research Boca Raton /ID# 240758Boca Raton, United StatesNo longer taking part
  • Beth Israel Deaconess Medical Center /ID# 240683Boston, United StatesNo longer taking part
  • Apex Clinical Trials /ID# 248558Brandon, United StatesNo longer taking part
  • CCD Research, PLLC /ID# 240728Cromwell, United StatesNo longer taking part
  • UCSF Fresno /ID# 240903Fresno, United StatesNo longer taking part
  • Burke Pharmaceutical Research /ID# 240811Hot Springs, United StatesNo longer taking part
  • Center for Clinical Studies - Houston (Binz) /ID# 240692Houston, United StatesNo longer taking part
  • Dawes Fretzin, LLC /ID# 240701Indianapolis, United StatesNo longer taking part
  • GSI Clinical Research, LLC /ID# 240901Margate, United StatesNo longer taking part
  • Florida International Rsrch cr /ID# 240902Miami, United StatesNo longer taking part
  • Mount Sinai Doctors Dermatology /ID# 241588New York, United StatesNo longer taking part
  • Schweiger Dermatology, P.C. /ID# 240900New York, United StatesNo longer taking part
  • Advanced Dermatology of the Midlands /ID# 249750Omaha, United StatesNo longer taking part
  • Duplicate_Skin Specialists, PC /ID# 240804Omaha, United StatesNo longer taking part
  • Park Avenue Dermatology, PA /ID# 240807Orange Park, United StatesNo longer taking part
  • Medical Dermatology Specialists /ID# 240641Phoenix, United StatesNo longer taking part
  • MediSearch Clinical Trials /ID# 240810Saint Joseph, United StatesNo longer taking part
  • Medderm Associates /ID# 240729San Diego, United StatesNo longer taking part
  • Mayo Clinic - Scottsdale /ID# 241030Scottsdale, United StatesNo longer taking part
  • Washington University-School of Medicine /ID# 240797St Louis, United StatesNo longer taking part
  • Montefiore Medical Center /ID# 240853The Bronx, United StatesNo longer taking part
  • Clinical Trials Research Institute /ID# 240642Thousand Oaks, United StatesNo longer taking part
  • Revival Research Institute, LLC /ID# 241020Troy, United StatesNo longer taking part
  • Essential Medical Research, LLC /ID# 241807Tulsa, United StatesNo longer taking part
  • Duplicate_TruDerm Dermatology of Wellington /ID# 240780Wellington, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 6 groups in the trial

  • Main Study: Lutikizumab Dose ATreatment being tested

    Lutikizumab Dose A every week

    Treatment: Lutikizumab

  • Main Study: Lutikizumab Dose BTreatment being tested

    Lutikizumab Dose B every other week

    Treatment: Lutikizumab

  • Main Study: Lutikizumab Dose CTreatment being tested

    Lutikizumab Dose C every other week

    Treatment: Lutikizumab

  • Main Study: PlaceboPlacebo, for comparison

    Placebo every week

    Treatment: Placebo

  • Sub-study: Group 1Treatment being tested

    Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.

    Treatment: Lutikizumab

  • Sub-study: Group 2Treatment being tested

    Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.

    Treatment: Lutikizumab

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Publications
Record updated
13 February 2026