Submit Modified Informed Consent Form with details: CDSCO Panel Tells Sanofi om Multiple Sclerosis Drug Tolebrutinib
New Delhi: Reviewing the Phase III clinical study protocol of Tolebrutinib presented by the drug major Sanofi, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm submit the modified Informed Consent Form mentioning the details about 11 times visit to the site.
Furthermore, the expert panel suggested the firm to submit the volume of samples to be collected and compensation to be paid in case of a visit to the site or home visit, clearance for shipping of samples outside the country, if any, and written assurance for a home visit if the patient is unable to visit the site.
This came after the drug major Sanofi presented phase III clinical study protocol no. LTS17043.
Tolebrutinib is a new drug being investigated for the treatment of relapsing, secondary, and primary progressive multiple sclerosis.
Tolebrutinib, a CNS-penetrant BTK inhibitor, has a dual mechanism of action, acting on both adaptive and innate immunity. Bruton's tyrosine kinase mediates adaptive immunity by coupling the antigenic stimulation of the B-cell receptor to nuclear signaling that leads to acute inflammatory responses.
At the recent SEC meeting for Neurology and Psychiatry held on 20th December 2023, the expert panel reviewed the Phase III clinical study of the multiple sclerosis drug Tolebrutinib.
After detailed deliberation, the committee opined that the firm should submit the following for review by the committee:
1. Modified Informed Consent Form mentioning the details about 11 times visit the site, volume of sample to be collected, and compensation to be paid in case of a visit to the site or home visit.
2 Clearance for shipping of samples outside the country, if any.
3. Written assurance for home visit if the patient is unable to visit the site.
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