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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
NCT05139602 · View on ClinicalTrials.gov ↗
Study 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 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 hi
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Lutikizumab
Study Locations (20)
Florida
- Skin Care Research Boca Raton /ID# 240758 — Boca Raton
- Apex Clinical Trials /ID# 248558 — Brandon
- GSI Clinical Research, LLC /ID# 240901 — Margate
- Florida International Rsrch cr /ID# 240902 — Miami
- Park Avenue Dermatology, PA /ID# 240807 — Orange Park
- Duplicate_TruDerm Dermatology of Wellington /ID# 240780 — Wellington
California
- UCSF Fresno /ID# 240903 — Fresno
- Medderm Associates /ID# 240729 — San Diego
- Clinical Trials Research Institute /ID# 240642 — Thousand Oaks
Arizona
- Medical Dermatology Specialists /ID# 240641 — Phoenix
- Mayo Clinic - Scottsdale /ID# 241030 — Scottsdale
Missouri
- MediSearch Clinical Trials /ID# 240810 — Saint Joseph
- Washington University-School of Medicine /ID# 240797 — St Louis
Nebraska
- Advanced Dermatology of the Midlands /ID# 249750 — Omaha
- Duplicate_Skin Specialists, PC /ID# 240804 — Omaha
Arkansas
- Burke Pharmaceutical Research /ID# 240811 — Hot Springs
Connecticut
- CCD Research, PLLC /ID# 240728 — Cromwell
Indiana
- Dawes Fretzin, LLC /ID# 240701 — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2021-12-28 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05139602
The ClinicalTrials.gov registry entry for NCT05139602 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05139602 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05139602 about?
NCT05139602 is a clinical study titled "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 (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 (TN...
What is the current status of trial NCT05139602?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2021-12-28. Estimated completion is 2027-12.
What conditions does trial NCT05139602 study?
This clinical trial studies the following conditions: Hidradenitis Suppurativa. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05139602?
The interventions under investigation include: Placebo (DRUG), Lutikizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05139602?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05139602 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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