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NCT06840392 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
A Phase 3 study of Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 555
- Enrollment target
- 20
- Study locations
NCT06840392: Recruiting Phase 3 study of Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals.
NCT06840392 is a Phase 3 study of Hidradenitis Suppurativa that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 555 participants, roughly in line with the 587-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06840392, a Phase 3 study of Hidradenitis Suppurativa, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 555 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
Primary Outcome
HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.
Conditions Studied
Interventions
- DRUG Remibrutinib Dose A
- DRUG Remibrutinib Dose B
- DRUG Placebo 1
- DRUG Placebo 2
Study Locations (20)
Florida
- Driven Research - Coral Gables
- Floridian Research Institute - Miami
- Sarasota Arthritis Res Ctr - Sarasota
- University Of South Florida - Tampa
California
- Ctr for Dermatology Clinical Res - Fremont
- USC Keck School of Medicine - Los Angeles
- MedDerm Associates - San Diego
Illinois
- Northwestern University - Chicago
- Endeavor Health - Glenview
- Dundee Dermatology - West Dundee
Arizona
- CTT Research - Gilbert
- Ctr Dermatology and Plastic Surgery - Scottsdale
Georgia
- Emory School of Med Dermatology - Atlanta
- Atlanta Biomedical Clin Res LLC - Atlanta
Massachusetts
- Beth Israel Deaconess Med Center - Boston
- Metro Boston Clinical Partners - Brighton
Alabama
- Total Skin and Beauty Dermatology Center PC - Birmingham
Indiana
- Southern IN Clinical Trials - New Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 555 participants |
| Start Date | 2025-03-20 |
| Est. Completion | 2028-02-07 |
| Phase | Phase 3 |
What NCT06840392 shows while recruiting
NCT06840392 is an interventional study that assigns participants to a tested intervention. The registered 555 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 587-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target.
The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 4 interventions - of which Remibrutinib Dose A is the first listed.
NCT06840392 names 20 study sites across 10 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06840392 about?
NCT06840392 is a clinical study titled "A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa". The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
What is the current status of trial NCT06840392?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 555 participants. The study started on 2025-03-20. Estimated completion is 2028-02-07.
What conditions does trial NCT06840392 study?
This clinical trial studies the following conditions: Hidradenitis Suppurativa.
What interventions are being tested in trial NCT06840392?
The interventions under investigation include: Remibrutinib Dose A (DRUG), Remibrutinib Dose B (DRUG), Placebo 1 (DRUG), Placebo 2 (DRUG).
Who is sponsoring clinical trial NCT06840392?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06840392 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06840392's enrollment target sits among peer trials
555 9th of 52 higher than 43 of 52 other Hidradenitis Suppurativa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hidradenitis Suppurativa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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