Title: A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)
Associated condition: Ulcerative colitis
Status: Currently enrolling
Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC). CBP-307 capsules are administered orally. This study includes stage 1 and stage 2. After screening, subjects will enter the randomized, double-blind, placebo-controlled induction therapy for 12 weeks, i.e., the study stage 1. All subjects who complete 12 weeks of induction therapy (with CBP-307 or placebo) in the study stage 1 and complete all examinations (including colonoscopy) at the week 12 visit can choose to enter the study stage 2 of a total of 40 weeks, including 36 weeks of continuous administration and 4 weeks of safety follow-up after the last dose.
Primary objectives: Compare clinical efficacy by evaluating the clinical response rate between Dose 2 and placebo at week 12. Clinical response is defined as a decrease of ≥ 3 points and at least 30% from baseline in the complete Mayo score, accompanied with a decrease of ≥ 1 point from baseline in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤ 1 point.
Estimated length of study: It is estimated that the study be fully completed by December 2022.
For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.
