Immunic Starts Enrollment in Phase 2 CALDOSE-1 Clinical Trial

Immunic Starts Enrollment in Phase 2 CALDOSE-1 Clinical Trial
The first patient has enrolled in the CALDOSE-1 phase 2 clinical trial, which seeks to determine whether Immunic AG's investigational drug IMU-838 can induce and maintain remission in patients with active ulcerative colitis (UC). The first sites for the trial are in the United States, and recruitment of participants is already underway across multiple U.S. sites. The primary goal of the CALDOSE-1 trial (NCT03341962) is to demonstrate the clinical efficacy of multiple doses of IMU-838 or placebo to induce remission in patients with active UC. The trial will also seek to determine the ability of IMU-838 to maintain remission. Ulcerative colitis is one of the two most common forms of inflammatory bowel disease (IBD), along with Crohn's disease. In Europe, several regulatory agencies have granted approvals for CALDOSE-1 and approximately 200 patients are expected to be enrolled in more than 80 sites across 10 countries in this global clinical trial. "After preparing this trial for many months in collaboration with international experts, we are very excited that the trial has now entered its enrollment phase," Dr. Andreas Muehler, Chief Medical Officer of Immunic, said in a press release. "Demonstration of clinical efficacy and confirmation of the most appropriate dose brings IMU-838 a step
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