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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.

Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona

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
  • Link to Clinical Trials

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