Ulcerative Colitis (UC)Phase 2NCT05377580
A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
A Phase 2 study testing Period 2 IBI112 dose 3, Period 1 IBI112 dose 1 and Period 1 IBI112 dose 2 in people with Ulcerative Colitis (UC), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Period 2 IBI112 dose 3, Period 1 IBI112 dose 1 and Period 1 IBI112 dose 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 7 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease;
- UC lesions were limited to rectum or involved colon < 15cm;
- Evidence of toxic hirschsprung's disease was found during screening;
- History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
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
To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.
Read the 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
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Period 1 IBI112 Placebo, Period 2 IBI112 dose 3, Period 1 IBI112 dose 1, Period 1 IBI112 dose 2, Period 2 IBI112 dose 4
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period 1 IBI112 PlaceboDrug
Also called Placebo
Intravenous Injection
Period 2 IBI112 dose 3Drug
Also called IBI112 dose 3
Subcutaneous injections
Period 1 IBI112 dose 1Drug
Also called IBI112 dose 1
Intravenous Injection
Period 1 IBI112 dose 2Drug
Also called IBI112 dose 2
Intravenous Injection
Period 2 IBI112 dose 4Drug
Also called IBI112 dose 4
Intravenous Injection
Period 2 IBI112 PlaceboDrug
Also called Placebo
Subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| Period 2 IBI112 dose 4 | Experimental | Not described Receives: Drug: Period 2 IBI112 dose 4 |
| Period 1 IBI112 Placebo | Placebo comparator | Not described Receives: Drug: Period 1 IBI112 Placebo |
| Period 2 IBI112 dose 3 | Experimental | Not described Receives: Drug: Period 2 IBI112 dose 3; Drug: Period 2 IBI112 Placebo |
| Period 1 IBI112 dose 2 | Experimental | Not described Receives: Drug: Period 1 IBI112 dose 2 |
| Period 2 IBI112 Placebo | Placebo comparator | Not described Receives: Drug: Period 2 IBI112 Placebo |
| Period 1 IBI112 dose 1 | Experimental | Not described Receives: Drug: Period 1 IBI112 Placebo; Drug: Period 1 IBI112 dose 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC)
Percentage of subjects who achieved clinical remission at week 12.
Measured: week 12
Secondary outcomes (11)
The proportion of participants achieving a clinical response at Week 12.
Clinical response is defined as a relative decrease from baseline in the modified Mayo score of ≥30% and ≥2 points, along with a relative decrease in the rectal bleeding subscore of ≥1 point or an absolute subscore of 0 or 1.
Measured: week 12
The proportion of participants achieving symptomatic relief at Week 12.
Symptomatic relief is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Measured: week 12
The proportion of participants achieving endoscopic remission at Week 12.
Endoscopic remission is defined as an endoscopic subscore of 0 or 1 within the modified Mayo score.
Measured: week 12
The proportion of participants achieving mucosal healing at Week 12.
Mucosal healing is defined as endoscopic remission, which means an endoscopic subscore of 0 or 1 within the modified Mayo score, and central Geboes histopathological index remission.
Measured: week 12
The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period.
Measured: week 52
The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period.
Measured: week 52
The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period.
Measured: week 52
The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period.
Measured: week 52
The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period.
Measured: week 52
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.
Measured: Week 12, Week 52，Weeks 24 and 64
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.
Measured: Week 12, Week 52，Weeks 24 and 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Jul 2022
- Primary completion21 Jun 2024
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377580
- Sponsor's protocol ID
- CIBI112B201
- Status last verified
- Nov 2025
- First submitted
- 6 May 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05377580
- Acronym / sponsor ID
- CIBI112B201
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Period 2 IBI112 dose 4 | Experimental | Drug: Period 2 IBI112 dose 4 |
| Period 1 IBI112 Placebo | Placebo comparator | Drug: Period 1 IBI112 Placebo |
| Period 2 IBI112 dose 3 | Experimental | Drug: Period 2 IBI112 dose 3, Drug: Period 2 IBI112 Placebo |
| Period 1 IBI112 dose 2 | Experimental | Drug: Period 1 IBI112 dose 2 |
| Period 2 IBI112 Placebo | Placebo comparator | Drug: Period 2 IBI112 Placebo |
| Period 1 IBI112 dose 1 | Experimental | Drug: Period 1 IBI112 Placebo, Drug: Period 1 IBI112 dose 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (4 listed)
- Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease;
- UC lesions were limited to rectum or involved colon < 15cm;
- Evidence of toxic hirschsprung's disease was found during screening;
- History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Period 1 IBI112 PlaceboAlso: PlaceboIntravenous Injection | Drug | Period 1 IBI112 Placebo, Period 1 IBI112 dose 1 |
| Period 2 IBI112 dose 3Also: IBI112 dose 3Subcutaneous injections | Drug | Period 2 IBI112 dose 3 |
| Period 1 IBI112 dose 1Also: IBI112 dose 1Intravenous Injection | Drug | Period 1 IBI112 dose 1 |
| Period 1 IBI112 dose 2Also: IBI112 dose 2Intravenous Injection | Drug | Period 1 IBI112 dose 2 |
| Period 2 IBI112 dose 4Also: IBI112 dose 4Intravenous Injection | Drug | Period 2 IBI112 dose 4 |
| Period 2 IBI112 PlaceboAlso: PlaceboSubcutaneous injections | Drug | Period 2 IBI112 Placebo, Period 2 IBI112 dose 3 |
Primary outcome
Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC)
Time frame: week 12
Percentage of subjects who achieved clinical remission at week 12.
11 secondary outcomes
The proportion of participants achieving a clinical response at Week 12.
Time frame: week 12
The proportion of participants achieving symptomatic relief at Week 12.
Time frame: week 12
The proportion of participants achieving endoscopic remission at Week 12.
Time frame: week 12
The proportion of participants achieving mucosal healing at Week 12.
Time frame: week 12
The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period.
Time frame: week 52
The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period.
Time frame: week 52
The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period.
Time frame: week 52
The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period.
Time frame: week 52
The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period.
Time frame: week 52
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.
Time frame: Week 12, Week 52，Weeks 24 and 64
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.
Time frame: Week 12, Week 52，Weeks 24 and 64
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis (UC)
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
RecruitingPhase 2
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Period 2 IBI112 dose 3, Period 1 IBI112 dose 1 and Period 1 IBI112 dose 2 in people with Ulcerative Colitis (UC), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC) (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.