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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
HRS-7085 Low dose po
HRS-7085 High dose po
Placebo po
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGProportion of subjects experiencing at least one Adverse Event
Time frame: at Week 14
Proportion of subjects achieving clinical response
Time frame: at Week 8
Proportion of subjects achieving symptomatic remission,
Time frame: at Week 8
Proportion of subjects achieving clinical remission
Time frame: at Week 8
Change from baseline in partial Mayo score,
Time frame: at week8、week12
Change from baseline in EQ-5D-5L (5-Level EuroQol 5-Dimension) index score,
Time frame: at Week 8
Peak Plasma Concentrations (Cmax)
Time frame: at Week 4
Area Under the Curve (AUC) of Plasma Concentrations
Time frame: at Week 4
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