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Ensayo clínico de rilzabrutinib en pacientes con urticaria crónica espontánea (UCE) de moderada a grave

THE OBJECTIVE OF THE STUDY IS TO EVALUATE THE EFFICACY AND SAFETY OF RILZABRUTINIB IN REDUCING SIGNS AND SYMPTOMS IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA (CSU) WHO CONTINUE TO HAVE SYMPTOMS DESPITE THE USE OF H1 ANTIHISTAMINES (H1AH). THIS STUDY IS BEING CONDUCTED IN PATIENTS WHO HAVE NEVER RECEIVED OMALIZUMAB.

Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, MULTICENTER, DOSE-RANGING STUDY OF RILZABRUTINIB FOLLOWED BY AN OPEN-LABEL EXTENSION PHASE IN PATIENTS WITH MODERATE TO SEVERE CHRONIC SPONTANEOUS URTICARIA (CSU) WHO REMAIN SYMPTOMATIC DESPITE THE USE OF H1 ANTIHISTAMINE THERAPY AND WITHOUT PRIOR TREATMENT WITH OMALIZUMAB. IMMUNOTHERAPY
  • Code EudraCT: 2021-002609-93
  • Protocol number: DRI17224
  • Promoter: Sanofi-Aventis S.A.
  • Link to Clinical Trials

* 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.

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