The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Participants will be randomized to receive HSK47388, orally starting at Week 0 . At Week-12, all participants will be evaluated for clinical response and responders will enter the maintenance study.
Participants will be randomized to receive Placebo, orally starting at Week 0 . At Week-12, all participants will be evaluated for clinical response and responders will enter the maintenance study.
Sir Run Run Shaw Hospital
Hangzhou, China
RECRUITINGThe proportion of patients with clinical response
Time frame: Week 12
The proportion of patients with clinical remission
Time frame: Week 12
The proportion of patients with symptomatic remission
Time frame: Week 12
The proportion of patients with endoscopic remission
Time frame: Week 12
Proportion of patients with Mayo endoscopic subscore 0
Time frame: Week 12
Percent change from baseline in Mayo score and modified Mayo score
Time frame: Week 12
Percent change from baseline in partial Mayo score
Time frame: Week 12
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