A multicenter, double-blind, placebo-controlled, randomized withdrawal and open -label extension study followed by long-term open-table treatment cycles to assess the efficacy, safety, and tolerability of remibrutinib ( LOU064) in adult chronic spontaneou
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
III
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
Johns Hopkins Bayview Medical Center
4940 Eastern Ave Baltimore, MD 21224
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Research_Recruitment@jh.eduBrief Summary
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies.
This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
Eligibility
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.