This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of SHR-1139 in patients with moderate to severe active ulcerative colitis. This study consists 2 treatment parts, the Induction treatment part and Maintenance treatment part. The periods of Induction treatment part and Maintenance treatment part are 12 weeks and 48 weeks separately.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
SHR-1139 intravenous injection.
The First Affiliated Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGThe proportion of subjects who achieve clinical response (based on modified Mayo score) at week 12.
Time frame: at week 12.
The proportion of subjects who achieve clinical remission (based on modified Mayo score) at week 12 and week 60.
Time frame: at week 12 and week 60.
The proportion of subjects who achieve endoscopic improvement, endoscopic remission and systemic remission at week 12 and week 60.
Time frame: at week 12 and week 60.
The proportion of subjects who achieve clinical response (based on modified Mayo score) at week 60.
Time frame: at week 12 and week 60.
The proportion of subjects whose partial Mayo score ≤1 at each visit.
Time frame: at week 4, 8, 12, 22, 36, 42 and week 60.
The proportion of subjects whose total Mayo score ≤2 and no individual sub-score >1 at week 12 and week 60.
Time frame: at week 12 and week 60.
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