This study will evaluate the efficacy and safety of 627 in patients with UC.
Ulcerative colitis (UC) is a chronic non-specific intestinal disease characterized by continuous and diffuse inflammatory changes in the colorectal mucosa. Despite the availability of advanced therapies, there remains a significant unmet medical need, such as inadequate or loss of response to one or more of the following therapies, corticosteroid dependence, or intolerance to one or more therapies. The purpose of this study is to evaluate the efficacy and safety of 627 in patients with moderate to severe UC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGNumber of participants with Adverse Events
Time frame: During the 36-week study period
Clinical remission based on Mayo Score (MMS)
Proportion of subjects achieving clinical remission based on Mayo Score (MMS) (Rectal Bleeding Score \[RBS\] = 0, Endoscopic Score \[ES\] ≤ 1 without friability, and Stool Frequency Score \[SFS\] ≤ 1and not exceeding baseline).
Time frame: Week 14
Clinical response based on Mayo Score (MMS)
Proportion of subjects achieving clinical response based on Mayo Score (MMS) (≥2-point and ≥30% reduction in MMS from baseline, and ≥1-point reduction in Rectal Bleeding Score \[RBS\] or RBS value ≤1 point).
Time frame: Week 14
Endoscopic improvement
Proportion of subjects achieving endoscopic improvement (Endoscopic Score \[ES\] ≤ 1 without friability).
Time frame: Week 14
Endoscopic remission
Proportion of subjects achieving endoscopic remission (Endoscopic Score \[ES\] = 0).
Time frame: Week 14
Symptomatic remission
Proportion of subjects achieving symptomatic remission (Rectal Bleeding Score \[RBS\] = 0 and Stool Frequency Score \[SFS\] = 0).
Time frame: During the 36-week study period
Symptomatic response
Proportion of subjects achieving symptomatic response (≥30% reduction from baseline in combined RBS and SFS total scores).
Time frame: During the 36-week study period
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Time to achievement of symptomatic remission and symptomatic response
Time frame: During the 36-week study period