Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
NCT06468228 · 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. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks. Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks. Participants in the US that complete Periods 1 \& 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the lo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lutikizumab
Study Locations (20)
Florida
- Clearlyderm Dermatology - West Boca /ID# 265023 — Boca Raton
- Apex Clinical Trials /ID# 263815 — Brandon
- TrueBlue Clinical Research /ID# 265041 — Brandon
- Florida Academic Dermatology Center /ID# 263834 — Coral Gables
- Direct Helpers Research Center /ID# 278343 — Hialeah
- Skin Care Research - Hollywood /ID# 263805 — Hollywood
- GSI Clinical Research, LLC /ID# 263827 — Margate
- Sullivan Dermatology /ID# 263511 — Miami
California
- Private Practice - Dr. Tooraj Raoof /ID# 263756 — Encino
- NorCal Medical Research /ID# 279008 — Greenbrae
- Dermatology Research Associates - Los Angeles /ID# 263765 — Los Angeles
- Stanford University School of Medicine - Redwood City /ID# 263711 — Redwood City
- Integrative Skin Science and Research /ID# 264600 — Sacramento
- Clinical Trials Research Institute /ID# 263743 — Thousand Oaks
Arizona
- Medical Dermatology Specialists /ID# 263394 — Phoenix
- Banner University Medicine Dermatology /ID# 263557 — Tucson
Arkansas
- Dermatology Trial Associates /ID# 264587 — Bryant
- Arkansas Research Trials /ID# 263901 — North Little Rock
Alabama
- Cahaba Dermatology & Skin Health Center /ID# 263795 — Birmingham
Connecticut
- Yale University School of Medicine /ID# 263695 — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,280 participants |
| Start Date | 2024-06-27 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06468228
The ClinicalTrials.gov registry entry for NCT06468228 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 1,280 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: NCT06468228 reports 20 study locations spanning 6 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 NCT06468228 about?
NCT06468228 is a clinical study titled "A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa". 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. This study will compare lutikizumab versus placebo for the ...
What is the current status of trial NCT06468228?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,280 participants. The study started on 2024-06-27. Estimated completion is 2026-12.
What conditions does trial NCT06468228 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 NCT06468228?
The interventions under investigation include: Placebo (DRUG), Lutikizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06468228?
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 NCT06468228 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.