An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

Phase 3

Recruiting

• Conditions: chronic spontaneous urticaria

• Registration Number: JPRN-jRCT2031220499
• Lead Sponsor: Hirano Takamitsu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed.
- Male and female, adult participants >=18 years of age.
- Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
- Willing and able to adhere to the study protocol and visit schedule.

Exclusion Criteria

- Significant bleeding risk or coagulation disorders.
- History of gastrointestinal bleeding.
- Requirement for anti-platelet medication.
- Requirement for anticoagulant medication.
- History or current hepatic disease.
- Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified