Equillium, Biocon initiate itolizumab study

Equillium announced that Biocon, in collaboration with Equillium, has initiated a Phase 2 clinical study of itolizumab in patients with ulcerative colitis, or UC. The Phase 2 double-blinded placebo-controlled clinical study is evaluating the safety and efficacy of itolizumab for biologics-naive patients with moderate to severe active UC, where patients are randomized 1:1:1 to receive a fixed dose of 140 mg of itolizumab, adalimumab, or placebo every two weeks for a 12-week treatment period, with adalimumab non-responders able to cross over to itolizumab. The study is expected to enroll up to 90 patients in multiple clinical trial sites in India. The trial design and initiation have been a collaborative effort, with help from the gastroenterologist community and leading global clinical and scientific experts in the field of inflammatory bowel disease, or IBD.