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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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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