NCT05377580CompletedPhase 2
A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
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
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 6 May 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 21 Jun 2024
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Ulcerative colitis
- NCT number
- NCT05377580
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 150
- From 1 Jul 2022 to the primary completion date, 21 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease;
- Evidence of toxic hirschsprung's disease was found during screening;
Other
- UC lesions were limited to rectum or involved colon \< 15cm;
- History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;
Who the study is looking for
- Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting UC and histopathological evidence supporting UC diagnosis;
- Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2;
- Subject must have received at least one prior treatment or first use of a biological agent:
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.