Subject Expert Committee of CDSCO recommends to grant permission to Biocon to conduct phase 2 clinical trial for Itolizumab for Injection (r-DNA origin) 100 mg per vial.
The firm presented the clinical trial protocol titled A Phase II randomized, double-blind, parallel-group, placebo and active-controlled, two treatment period study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naïve patients with moderate to severely active ulcerative colitis vide protocol number BIO-ITOLIZ-207, Dated 11-May- 2022.
The committee noted that the drug is already approved for active moderate to severe chronic plaque psoriasis and the firm has conducted a Phase I study of the safety, tolerability, PK, PD, and bioavailability of Itolizumab in healthy volunteers at doses ranging from 0.4 to 3.2 mg/kg in Australia.
After detailed deliberation, the committee recommended to grant permission to conduct the Phase II study as presented.
