A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Condition(s) studied
Investigational drug(s) / intervention(s)
Remibrutinib Dose A: Remibrutinib Dose A (oral)
Remibrutinib Dose B: Remibrutinib Dose B (oral)
Placebo 1: Placebo matching to remibrutinib Dose A (oral)
Placebo 2: Placebo matching to remibrutinib Dose B (oral)
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).
Eligibility
Primary outcome measure(s)
- Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16 — Week 16
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.
Trial sites (130)
| Facility | City | Region | Status |
|---|---|---|---|
| Total Skin and Beauty Dermatology Center PC | Birmingham | Alabama | |
| CTT Research | Gilbert | Arizona | |
| Ctr for Dermatology Clinical Res | Fremont | California | |
| USC Keck School of Medicine | Los Angeles | California | |
| MedDerm Associates | San Diego | California | |
| Driven Research | Miami | Florida | |
| Floridian Research Institute | Miami | Florida | |
| Sarasota Arthritis Res Ctr | Sarasota | Florida | |
| University Of South Florida | Tampa | Florida | |
| Emory School of Med Dermatology | Atlanta | Georgia | |
| Atlanta Biomedical Clin Res LLC | Atlanta | Georgia | |
| Northwestern University | Chicago | Illinois | |
| Endeavor Health | Glenview | Illinois | |
| Dundee Dermatology | West Dundee | Illinois | |
| Southern IN Clinical Trials | New Albany | Indiana | |
| Beth Israel Deaconess Med Center | Boston | Massachusetts | |
| Metro Boston Clinical Partners | Brighton | Massachusetts | |
| Clinical Research Inst of MI | Chesterfield | Michigan | |
| Deluxe Dermatology | St Louis | Missouri | |
| Skin Specialists PC | Omaha | Nebraska | |
| Vivida Dermatology | Las Vegas | Nevada | |
| North Shore University Hospital | New Hyde Park | New York | |
| Cameron Dermatology | New York | New York | |
| Optima Research Boardman | Boardman | Ohio | |
| Ohio State University | Columbus | Ohio | |
| Wright State University | Fairborn | Ohio | |
| Apex Clinical Research Center LLC | Mayfield Heights | Ohio | |
| Clinical Research Ctr of Carolinas | Charleston | South Carolina | |
| Goodlettsville Dermatology Research | Goodlettsville | Tennessee | |
| Accurate Clinical Research | Humble | Texas | |
| Austin Inst for Clinical Research | Pflugerville | Texas | |
| Center for Clinical Studies-Lee | Webster | Texas | |
| Care Access Alexandria | Arlington | Virginia | |
| Complexions Dermatology | Danville | Virginia | |
| Forefront Dermatology | Vienna | Virginia | |
| Novartis Investigative Site | Córdoba | Córdoba Province | |
| Novartis Investigative Site | CABA | Argentina | |
| Novartis Investigative Site | Caba | Argentina | |
| Novartis Investigative Site | Linz | Austria | |
| Novartis Investigative Site | Brussels | Brussels Capital |
+ 90 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06840392 on ClinicalTrials.gov ↗ ← All trials in Mexico