Clinical trial NCT05377580: A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
Official title: A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI112 in Patients With Moderate to Severe Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis (UC)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.

Detailed description: This is a phase 2 randomized,double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI112 induction and maintenance therapy in subjects with moderate to severe active ulcerative colitis

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting UC and histopathological evidence supporting UC diagnosis;
2. Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2;
3. Subject must have received at least one prior treatment or first use of a biological agent:

Exclusion Criteria:

1. Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease;
2. UC lesions were limited to rectum or involved colon \< 15cm;
3. Evidence of toxic hirschsprung's disease was found during screening;
4. History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;

Primary outcomes:
measure: Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC)
timeFrame: week 12
Secondary outcomes:
measure: The proportion of participants achieving a clinical response at Week 12.
timeFrame: week 12
measure: The proportion of participants achieving symptomatic relief at Week 12.
timeFrame: week 12
measure: The proportion of participants achieving endoscopic remission at Week 12.
timeFrame: week 12
measure: The proportion of participants achieving mucosal healing at Week 12.
timeFrame: week 12
measure: The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period.
timeFrame: week 52
measure: The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period.
timeFrame: week 52
measure: The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period.
timeFrame: week 52
measure: The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period.
timeFrame: week 52
measure: The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period.
timeFrame: week 52
measure: The change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period.
timeFrame: Week 12, Week 52，Weeks 24 and 64
measure: The change from baseline in the 36-item Short Form Health Survey (SF-36) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period.
timeFrame: Week 12, Week 52，Weeks 24 and 64
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: