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

NCT05377580 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-11-19

No results posted yet for this study

Summary

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

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

Period 1 IBI112 Placebo

Intravenous Injection

DRUG

Period 2 IBI112 dose 3

Subcutaneous injections

DRUG

Period 1 IBI112 dose 1

Intravenous Injection

DRUG

Period 1 IBI112 dose 2

Intravenous Injection

DRUG

Period 2 IBI112 dose 4

Intravenous Injection

DRUG

Period 2 IBI112 Placebo

Subcutaneous injections

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-06-21
Completion
2025-08-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377580 on ClinicalTrials.gov