An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
Key facts
- Where
- Birmingham, Boardman, Charleston, Fort Smith, Fremont, Glenview, Huntersville, Los Angeles, Mayfield Heights, Miami, New Albany, New York, North Little Rock, Omaha, Pittsburgh, Rochester, San Antonio, Sylmar, Tampa, Thousand Oaks, Troy, Vienna, Webster, and West Dundee, United StatesSee the 27 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 United States
- Total Skin and Beauty Dermatology Center, PCBirmingham, United StatesContact: Brittany PowellTaking people
- Optima Research BoardmanBoardman, United StatesContact: Sarah MerloTaking people
- Clinical Research Ctr of CarolinasCharleston, United StatesContact: Gina GregoryTaking people
- Medical University of South Carolina (MUSC)Charleston, United StatesContact: Madeline RichmondTaking people
- Johnson DermatologyFort Smith, United StatesContact: Christa ElliottTaking people
- Ctr for Dermatology Clinical ResFremont, United StatesContact: Evguenia ValsTaking people
- Endeavor HealthGlenview, United StatesContact: Megan CalderonTaking people
- OnSite Clinical Solutions LLCHuntersville, United StatesContact: April PageTaking people
- USC Keck School of MedicineLos Angeles, United StatesContact: Rudy RochaTaking people
- Apex Clinical Research Center, LLCMayfield Heights, United StatesContact: Stacey SpigielTaking people
- Floridian Research InstituteMiami, United StatesContact: Luis Javier ArechavaletaTaking people
- University of MiamiHealth SystemMiami, United StatesContact: Aliette EspinosaTaking people
- Southern IN Clinical TrialsNew Albany, United StatesContact: Misty HumphressTaking people
- Cameron DermatologyNew York, United StatesContact: Yamiles GonzalezTaking people
- Icahn School Of Med At Mount SinaiNew York, United StatesContact: Jillian GrayTaking people
- Arkansas Research TrialsNorth Little Rock, United StatesContact: Shawna OwensTaking people
- Skin Specialists, PCOmaha, United StatesContact: Kayleigh KoziolTaking people
- UP Medical Center H SystemPittsburgh, United StatesContact: Carisa ByichTaking people
- Skinsearch of Rochester IncRochester, United StatesContact: Angela MaliziaTaking people
- RFSA DermatologySan Antonio, United StatesContact: Jonathan JosephTaking people
- Olive View-UCLA Medical CenterSylmar, United StatesContact: Noel YangTaking people
- University of South FloridaTampa, United StatesContact: Zachary LeniekTaking people
- Clinical Trials Research InstituteThousand Oaks, United StatesContact: Joanna VargasTaking people
- Revival Research InstituteTroy, United StatesContact: Jill SolankiTaking people
- Forefront DermatologyVienna, United StatesContact: Jacqueline HenleyTaking people
- Center for Clinical Studies-LeeWebster, United StatesContact: Karina GonzalezTaking people
- Dundee DermatologyWest Dundee, United StatesContact: JoAnn HawkinsonTaking 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.