An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
Key facts
- Where
- CABA and Rosario, ArgentinaSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT07665437, who can take part
Where in Argentina
- CABA, Buenos AiresHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- Rosario, Santa Fe ProvinceHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07665437EU 2025-523259-72-00
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
A Double-blind, Double-dummy, Parallel Group, Multicenter Phase 3 Extension Study Evaluating the Long-term Safety and Efficacy of 2 Doses of Remibrutinib in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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.
Inclusion: 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.
Exclusion: 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; 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.