This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.
Male and female subject age ≥ 18，≤75.
the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ².
Subject has active Ulcerative Colitis with a 9-point modified Mayo score of 4-9 at baseline, with an endoscopic subscore of ≥ 2 (confirmed by central read), and rectal bleeding subscore of ≥1.
Subject has at least a 90-days history of Ulcerative Colitis diagnosis at baseline.
Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease.
Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
Treatment naïve subject diagnosed with Ulcerative Colitis.
Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
Parallel
HRS-7085
DrugHRS-7085 Low dose po
HRS-7085
DrugHRS-7085 High dose po
Placebo
DrugPlacebo po
Proportion of subjects experiencing at least one Adverse Event
Proportion of subjects achieving clinical response
Proportion of subjects achieving symptomatic remission,
Proportion of subjects achieving clinical remission
Change from baseline in partial Mayo score,
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