Canada the First to Approve Phase 2b Trial of Abivax’s ABX464 for Ulcerative Colitis

Canada the First to Approve Phase 2b Trial of Abivax’s ABX464 for Ulcerative Colitis
Canada has become the first country to fully authorize a Phase 2b clinical trial that will explore Abivax's lead candidate ABX464 in patients with ulcerative colitis, the company announced. ABX464 was granted complete regulatory and ethics approval in Canada, and the first patient is expected to be enrolled in the trial in the second quarter of this year, Hartmut J. Ehrlich, MD, CEO of Abivax, said in a press release. In addition to Canada, the Phase 2b trial (NCT03760003) is expected to be largely conducted in Europe, with up to 150 sites across more than 15 countries. It will enroll approximately 232 patients with moderate to severe ulcerative colitis, who will be randomized into four groups. Three groups will receive escalating doses of once-daily oral ABX464 — 25 mg, 50 mg, or 100 mg per day — and the last group will receive a placebo for control. Participants will receive the treatment for 16 weeks. After completion of the study, patients will have the opportunity to continue treatment with ABX464o in an open-label maintenance study. Top-line results from this trial are expected to be presented by the end of 2020. The primary goal of the trial is to assess changes in modified Mayo Score (which measures ulcerative colitis disease activity) at eight weeks compared with before starting the treatment. Researchers will also evaluate the impact of the treatment on different disease-associated features, such as endoscopi
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