Get to know our clinical trials
Clinical trial to evaluate the efficacy, safety and tolerability of remibrutinib in adult patients with chronic spontaneous urticaria
THE PURPOSE OF THE STUDY IS TO TEST WHETHER REMIBRUTINIB IS SAFE AND CAN HELP ADULT PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA. THE STUDY WILL ALSO EVALUATE WHETHER TREATMENT WITH REMIBRUTINIB FOR A LONGER PERIOD OF TIME RESULTS IN DISEASE IMPROVEMENT OR RECOVERY. IT WILL ALSO DETERMINE HOW LONG THE DESIRED EFFECT IS MAINTAINED WITH REMIBRUTINIB TREATMENT AFTER HAVING RECEIVED REMIBRUTINIB OR OMALIZUMAB IN PREVIOUS STUDIES. IN ADDITION, THIS STUDY WILL ASSESS WHETHER REMIBRUTINIB HAS THE DESIRED EFFECT IN A SMALL GROUP OF PARTICIPANTS WHO DO NOT RECEIVE THE BASELINE ANTIHISTAMINE MEDICATION.
Technical Summary
- MULTICENTER, OPEN-LABEL, DOUBLE-BLIND, PLACEBO-CONTROLLED EXTENSION STUDY WITH RANDOMIZED WITHDRAWAL FOLLOWED BY LONG-TERM OPEN-LABEL TREATMENT COURSES TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF REMIBRUTINIB (LOU064) IN ADULT PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA WHO HAVE COMPLETED PREVIOUS PHASE III STUDIES OF REMIBRUTINIB
- Code EudraCT: 2022-001034-11
- Protocol number: CLOU064A2303B
- Promoter: Novartis Farmaceutica
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
Do you want to participate in this trial?
Request an appointment for our specialists to assess whether you qualify for this clinical trial
Do you prefer to send us your reports?
If you prefer, you can send us your medical information and our specialists will evaluate your case without the need to come to the Clinica.