CDSCO Panel grants Novartis Protocol Amendment Proposal to study Remibrutinib in Chronic Spontaneous Urticaria
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Novartis for an extension study of long-term efficacy, safety, and tolerability of Remibrutinib in chronic spontaneous urticaria patients who completed preceding studies with remibrutinib.
This came after the drug maker Novartis presented protocol amendment version 01 dated 28.02.2024 protocol No. CLOU064A2303B.
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.
Chronic spontaneous urticaria is defined as the occurrence of wheals and/or angioedema for a total duration of six weeks or more.
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