A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
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 (139)
| Facility | City | Region | Status |
|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | |
| Johnson Dermatology | Fort Smith | Arkansas | |
| Arkansas Research Trials | North Little Rock | Arkansas | |
| Cheryl Effron MD Inc | Anaheim | California | |
| Physioseq | Sacramento | California | |
| Olive View UCLA Medical Center | Sylmar | California | |
| Clinical Trials Research Institute | Thousand Oaks | California | |
| Howard University College of Medicine | Washington D.C. | District of Columbia | |
| Florida Academic Centers Research and Education LLC | Coral Gables | Florida | |
| University of MiamiHealth System | Miami | Florida | |
| Ziaderm Research LLC | North Miami Beach | Florida | |
| Revival Research Institute LLC | Evans | Georgia | |
| Gwinnett Clinical Research Center | Snellville | Georgia | |
| Immunology-Rheumatology Research | Suwanee | Georgia | |
| Illinois Dermatology Institute | Chicago | Illinois | |
| Dawes Fretzin Clinical Rea Group | Indianapolis | Indiana | |
| Equity Medical LLC | Bowling Green | Kentucky | |
| Dermat. and Adv. Aesthetics | Lake Charles | Louisiana | |
| Michigan Center for Rsrch Company | Clarkston | Michigan | |
| Henry Ford Hospital | Detroit | Michigan | |
| Revival Research Institute | Troy | Michigan | |
| University of Mississippi Med Ctr | Jackson | Mississippi | |
| Care Access Hoboken | Hoboken | New Jersey | |
| Forest Hills Dermatology Group | New York | New York | |
| Icahn School Of Med At Mount Sinai | New York | New York | |
| Skinsearch of Rochester Inc | Rochester | New York | |
| OnSite Clinical Solutions LLC | Huntersville | North Carolina | |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | |
| Unity Clinical Research | Oklahoma City | Oklahoma | |
| Essential Medical Research | Tulsa | Oklahoma | |
| UP Medical Center H System | Pittsburgh | Pennsylvania | |
| Medical University of South Carolina MUSC | Charleston | South Carolina | |
| Advanced Research Experts | Nashville | Tennessee | |
| Bellaire Dermatology Associates | Bellaire | Texas | |
| RFSA Dermatology | San Antonio | Texas | |
| Virginia Clinical Research | Norfolk | Virginia | |
| Novartis Investigative Site | Caba | Buenos Aires | |
| Novartis Investigative Site | CABA | Buenos Aires | |
| Novartis Investigative Site | Rosario | Santa Fe Province | |
| Novartis Investigative Site | CABA | Argentina |
+ 99 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Spain
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 NCT06799000 on ClinicalTrials.gov ↗ ← All trials in Spain