CDSCO Panel Approves IQVIA RDS's Protocol Amendment Proposal for Spesolimab study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-11T17:15:54+05:30 | Updated On 11 Aug 2024 5:15 PM IST

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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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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751