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New hope for ulcerative colitis: drug shows promise in early trial

NCT ID NCT05377580

Disease control Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called IBI112 in 150 people with moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon. The goal was to see if IBI112 could help patients achieve remission (no symptoms) after 12 weeks of treatment. Participants were randomly assigned to receive either IBI112 or a placebo, and neither they nor their doctors knew which they received.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

150 people

The number who actually took part.

Started

Jul 2022

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis (UC)

Contacts and locations

Locations

  • First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.