A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis
Trial Parameters
Brief Summary
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The target population is patients with moderately to severely active ulcerative colitis. A total of 120 subjects are planned to be included.
Eligibility Criteria
Inclusion Criteria: Subjects who meet all of the following criteria can be included in this study: 1. Subjects voluntarily take part in the study after being fully informed, sign a written informed consent form (ICF), and agree to follow procedures specified in the study protocol; 2. Males and females, 18 to 70 years of age, inclusive at the time of signing of ICF; 3. Have had an established diagnosis of ulcerative colitis (UC) of ≥ 3 months in duration prior to signing of ICF, which is supported by endoscopy reports, histopathology reports and clinical manifestations consistent with UC, as determined by investigators; 4. Involved intestinal segment extending ≥ 15 cm from the anal verge as confirmed by a screening endoscopy; 5. Active moderate to severe UC, defined by a modified Mayo score of 5 to 9 points at screening, which includes a stool frequency (SF) subscore of ≥ 2, a rectal bleeding (RB) subscore ≥ 1 and an endoscopic (ES) subscore of ≥ 2 (based on a screening endoscopy, confi