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Clinical trial to investigate the efficacy, safety and tolerability of remibrutinib (LOU064) in chronic inducible urticaria (CINDU) in adults inadequately controlled with H1 antihistamines.
THE AIM OF THE STUDY IS TO FIND OUT WHETHER REMIBRUTINIB IS SAFE AND TO WHAT EXTENT IT IS TOLERATED BY THE BODY AND TO STUDY WHETHER IT HAS THE DESIRED EFFECT IN THE TREATMENT OF CHRONIC INDUCIBLE URTICARIA IN ADULTS TAKING ANTIHISTAMINES.
Technical Summary
- A 52-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, OPEN-LABEL, OPEN-LABEL, DOUBLE-BLIND BASKET STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF REMIBRUTINIB (LOU064) IN CHRONIC INDUCIBLE URTICARIA (CINDU) IN ADULTS INADEQUATELY CONTROLLED WITH H1 ANTIHISTAMINES.
- Code EudraCT: 2023-505739-12
- Protocol number: CLOU064M12301
- Promoter: Novartis Farmaceutica
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