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submit phase I and phase II data for Crohn's disease: CDSCO Panel tells Roche Products India on RO7790121 study

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-03-22 12:30 GMT   |   Update On 2025-03-23 03:30 GMT
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New Delhi: Reviewing Phase III clinical study protocol of the monoclonal antibody RO7790121, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the pharmaceutical major Roche Products (India) to submit the phase I and phase II data for Crohn’s disease for further review by the committee.

This came after the firm presented phase 3 clinical study protocol no. GA45332 version 1.0 dated 22 August 2024.

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RO7790121 is a monoclonal antibody TL1A that plays a role in the regulation of gut mucosal immunity and is involved in inflammatory bowel disease. A high unmet medical need remains for treatments with better benefit-risk profiles that provide sustained control to improve the long-term prognosis of patients with UC.

At the recent SEC meeting for gastroenterology and hepatology held on 27th February 2025, the expert panel reviewed phase 3 clinical study protocol no. GA45332 version 1.0 dated 22 August 2024.

After detailed deliberation, the committee opined that the firm should submit phase I and phase II data for Crohn’s disease for further review by the committee.

Also Read: Conduct BE study or present safety data: CDSCO Panel tells IQVIA on anti-cancer Drug Daratumumab study

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Dr. Divya Colin

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.

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