A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis

Innovent Biologics

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis (UC)

Treatments: Drug: Period 1 IBI112 dose 1; Drug: Period 1 IBI112 dose 2; Drug: Period 1 IBI112 Placebo; Drug: Period 2 IBI112 Placebo; Drug: Period 2 IBI112 dose 4; Drug: Period 2 IBI112 dose 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT05377580

CIBI112B201

Details and patient eligibility

About

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

Full 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

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 6 patient groups, including a placebo group

Period 2 IBI112 dose 4

Experimental group

Treatment:

Drug: Period 2 IBI112 dose 4

Period 1 IBI112 Placebo

Placebo Comparator group

Treatment:

Drug: Period 1 IBI112 Placebo

Period 2 IBI112 dose 3

Experimental group

Treatment:

Drug: Period 2 IBI112 dose 3

Drug: Period 2 IBI112 Placebo

Period 1 IBI112 dose 2

Experimental group

Treatment:

Drug: Period 1 IBI112 dose 2

Period 2 IBI112 Placebo

Placebo Comparator group

Treatment:

Drug: Period 2 IBI112 Placebo

Period 1 IBI112 dose 1

Experimental group

Treatment:

Drug: Period 1 IBI112 Placebo

Drug: Period 1 IBI112 dose 1