CDSCO Panel Approves IQVIA RDS's Protocol Amendment Proposal for Spesolimab study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved IQVIA RDS's protocol amendment proposal for the study of the monoclonal antibody Spesolimab.
This came after the firm presented clinical trial Phase IIIb/IV protocol amendment version 2.0 dated 23.01.2024 (protocol No. 1368-0120).
Spesolimab belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural protein in your body (interleukin-36) that may cause inflammation and swelling. Spesolimab works by inhibiting the inflammatory signaling pathway of IL-36, which is often overexpressed and aberrantly overactive in generalized pustular psoriasis.
At the recent meeting for the Dermatology and Allergy held on 11th July 2024, the expert panel reviewed the clinical trial Phase IIIb/IV protocol amendment version 2.0 dated 23.01.2024 (protocol No. 1368-0120).
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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