Clinical Trials in Spain / NCT07665437
Recruiting
Phase 3
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
NCT07665437 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Hidradenitis Suppurativa
Investigational drug(s) / intervention(s)
Remibrutinib: Remibrutinib Dose A and B (oral)
Study summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.
Eligibility
Key Inclusion Criteria:
* Signed informed consent must be obtained before any assessment is performed.
* Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
* Participant does not meet any treatment discontinuation criteria of the core study at Week 68.
Key Exclusion Criteria:
* Ongoing or planned use of prohibited HS or non-HS treatments.
* Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
* Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study.
Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — Baseline, up to Week 280
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe Hidradenitis Suppurativa.
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Johnson Dermatology | Fort Smith | Arkansas | Recruiting |
| Ctr for Dermatology Clinical Res | Fremont | California | Recruiting |
| USC Keck School of Medicine | Los Angeles | California | Recruiting |
| Olive View UCLA Medical Center | Sylmar | California | Recruiting |
| Clinical Trials Research Institute | Thousand Oaks | California | Recruiting |
| Floridian Research Institute | Miami | Florida | Recruiting |
| University Of South Florida | Tampa | Florida | Recruiting |
| Endeavor Health | Glenview | Illinois | Recruiting |
| Dundee Dermatology | West Dundee | Illinois | Recruiting |
| Southern IN Clinical Trials | New Albany | Indiana | Recruiting |
| Skin Specialists PC | Omaha | Nebraska | Recruiting |
| Cameron Dermatology | New York | New York | Recruiting |
| Icahn School Of Med At Mount Sinai | New York | New York | Recruiting |
| OnSite Clinical Solutions LLC | Huntersville | North Carolina | Recruiting |
| Optima Research Boardman | Boardman | Ohio | Recruiting |
| Apex Clinical Research Center LLC | Mayfield Heights | Ohio | Recruiting |
| Clinical Research Ctr of Carolinas | Charleston | South Carolina | Recruiting |
| Center for Clinical Studies-Lee | Webster | Texas | Recruiting |
| Novartis Investigative Site | Caba | Buenos Aires | Recruiting |
| Novartis Investigative Site | CABA | Buenos Aires | Recruiting |
| Novartis Investigative Site | Rosario | Santa Fe Province | Recruiting |
| Novartis Investigative Site | CABA | Argentina | Recruiting |
| Novartis Investigative Site | CABA | Argentina | Recruiting |
| Novartis Investigative Site | Sydney | New South Wales | Recruiting |
| Novartis Investigative Site | Melbourne | Victoria | Recruiting |
| Novartis Investigative Site | Edmonton | Alberta | Recruiting |
| Novartis Investigative Site | London | Ontario | Recruiting |
| Novartis Investigative Site | Montreal | Quebec | Recruiting |
| Novartis Investigative Site | Québec | Quebec | Recruiting |
| Novartis Investigative Site | Beijing | China | Recruiting |
| Novartis Investigative Site | Ipoh | Perak | Recruiting |
| Novartis Investigative Site | Kota Kinabalu | Sabah | Recruiting |
| Novartis Investigative Site | Selangor Darul Ehsan | Malaysia | Recruiting |
| Novartis Investigative Site | Barcelona | Catalonia | Recruiting |
More Novartis Pharmaceuticals trials in Spain
Other trials for the same condition
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
Enrolling by invitation
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Active, not recruiting
Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
Active, not recruiting
Official registry record
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 NCT07665437 on ClinicalTrials.gov ↗ ← All trials in Spain