Frontlight ResearchEarly access
Taking peoplePhase 3
A clinical trial to provide continued access to remibrutinib (LOU064) for people who are benefiting from it in a previous remibrutinib trial
Key facts
- Who runs it
- Novartis Pharma AG
- Where
- Bulgaria, Czechia, France, Germany, Poland, and Spain46 sites in 6 countriesChoose a country to see its sites
- Trial code
- EU 2025-524078-40-00
- U1111-1334-1653
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 154 people, planned
- Started
- 10 Jun 2026
- Expected to end
- 9 Jan 2034
- Type of study
- Interventional
- Record updated
- 29 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a dermatological or allergology indication. Participants who derive benefit from the treatment with remibrutinib but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons). If a participant relapses during the treatment-free follow-up period of the parent protocol, he/she can enter this protocol immediately
- Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator’s judgement
- Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or reimbursement guidelines
Who cannot take part
- Use of prohibited medications as listed in Table 6-4 of study protocol
- Participant has prematurely discontinued study treatment in the parent study
This trial has no sites in United States.
It has sites in 6 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
To evaluate long-term safety as assessed by occurrence of AEs/SAEs
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
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib
- Record updated
- 29 September 2026