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NCT06468228 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 3 study of Hidradenitis Suppurativa, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,280
- Enrollment target
- 20
- Study locations
NCT06468228 is a Phase 3 study of Hidradenitis Suppurativa that is actively recruiting participants, run by AbbVie. The registered enrollment target is 1,280 participants, above the 573-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (123% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT06468228, a Phase 3 study of Hidradenitis Suppurativa, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,280 participants
- Enrollment target
- 20
- Study locations
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 |
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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, categorized as Phase 3. The registered enrollment target is 1,280 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 573-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (123% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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.
NCT06468228 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Arizona.
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.
What interventions are being tested in trial NCT06468228?
The interventions under investigation include: Placebo (DRUG), Lutikizumab (DRUG).
Who is sponsoring clinical trial NCT06468228?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
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