Adult Patients With Moderately to Severely Active Ulcerative ColitisPhase 2NCT07232576
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis
A Phase 2 study testing SHR-1139 intravenous injection. in people with Adult Patients With Moderately to Severely Active Ulcerative Colitis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of SHR-1139 in patients with moderate to severe active ulcerative colitis. This study consists 2 treatment parts, the Induction treatment part and Maintenance treatment part. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adult Patients With Moderately to Severely Active Ulcerative Colitis
- What is being tested?
- SHR-1139 intravenous injection.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male and female subject age ≥ 18 and ≤ 75 years of age at screening.
- the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ² at the screening.
- Subject has active Ulcerative Colitis with a 9-point modified Mayo score of 4-9 at baseline, with an endoscopic subscore of ≥ 2 (confirmed by central read). (NOTE: endoscopy should be performed within 14 days prior to baseline visit), and rectal bleeding subscore of ≥1.
- Subject has at least a 90-days history of Ulcerative Colitis diagnosis at baseline.
- Subject is deemed by the physician as having inadequate response, loss of response or intolerance (Appendix 5) to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or was previously exposed to anti-TNF therapy (e.g., infliximab, adalimumab) or other biological treatment.
- Subject is capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspects of the study.
- All women of childbearing potential and their male partners must commit to using at least two methods of contraception with one method being highly effective throughout the duration of the study, and for 72 weeks after last dose of study medication.
Who cannot join
- Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease.
- Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
- Treatment naïve subject diagnosed with Ulcerative Colitis (without previous exposure to any of the following therapies for UC treatment: oral 5-ASA, corticosteroids, immunosuppressants, or biological treatments).
- Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
- Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
- Screening endoscopic examination revealed that the subjects had a history of gastrointestinal dysplasia (atypical hyperplasia)/cancer or dysplasia (atypical hyperplasia)/cancer. Except for completely resected low-grade dysplasia.
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- Subject has evidence of pathogenic bowel infection. Subjects had Clostridium difficile or other intestinal infection within 30 days of screening endoscopy or test positive at screening for C. difficile toxin or other intestinal pathogens.
- Subject currently has or had:
- 8.1 A clinically significant infection within 1 month of baseline (e.g., those requiring hospitalization or parenteral antimicrobial therapy or have opportunistic infections).
- 8.2 A history of more than one episode of herpes zoster, or disseminated zoster (single episode).
- 8.3 Any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
- 8.4 Any infection requiring antimicrobial therapy within 2 weeks of screening.
- Subject is receiving any of the following therapies:
- 9.1 Cyclosporine, mycophenolate, tacrolimus、JAK inhibitors within 4 weeks prior to baseline.
- 9.2 Interferon therapy within 8 weeks prior to baseline. 9.3 Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5-ASA within 2 weeks prior to baseline.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, 510080
About this study
Official title: A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With moderate-to- Severe Active Ulcerative Colitis.
This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of SHR-1139 in patients with moderate to severe active ulcerative colitis.
This study consists 2 treatment parts, the Induction treatment part and Maintenance treatment part. The periods of Induction treatment part and Maintenance treatment part are 12 weeks and 48 weeks separately.
- Being tested
- SHR-1139 intravenous injection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1139 intravenous injection.Drug
SHR-1139 intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR-1139 Injection Receives: Drug: SHR-1139 intravenous injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieve clinical response (based on modified Mayo score) at week 12.
Measured: at week 12.
Secondary outcomes (5)
The proportion of subjects who achieve clinical remission (based on modified Mayo score) at week 12 and week 60.
Measured: at week 12 and week 60.
The proportion of subjects who achieve endoscopic improvement, endoscopic remission and systemic remission at week 12 and week 60.
Measured: at week 12 and week 60.
The proportion of subjects who achieve clinical response (based on modified Mayo score) at week 60.
Measured: at week 12 and week 60.
The proportion of subjects whose partial Mayo score ≤1 at each visit.
Measured: at week 4, 8, 12, 22, 36, 42 and week 60.
The proportion of subjects whose total Mayo score ≤2 and no individual sub-score >1 at week 12 and week 60.
Measured: at week 12 and week 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Moderately to Severely Active Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232576
- Sponsor's protocol ID
- SHR-1139-202
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With moderate-to- Severe Active Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT07232576
- Acronym / sponsor ID
- SHR-1139-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Nov 2025 (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.
This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of SHR-1139 in patients with moderate to severe active ulcerative colitis.
This study consists 2 treatment parts, the Induction treatment part and Maintenance treatment part. The periods of Induction treatment part and Maintenance treatment part are 12 weeks and 48 weeks separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1139 intravenous injection.SHR-1139 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subject age ≥ 18 and ≤ 75 years of age at screening.
- the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ² at the screening.
- Subject has active Ulcerative Colitis with a 9-point modified Mayo score of 4-9 at baseline, with an endoscopic subscore of ≥ 2 (confirmed by central read). (NOTE: endoscopy should be performed within 14 days prior to baseline visit), and rectal bleeding subscore of ≥1.
- Subject has at least a 90-days history of Ulcerative Colitis diagnosis at baseline.
- Subject is deemed by the physician as having inadequate response, loss of response or intolerance (Appendix 5) to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or was previously exposed to anti-TNF therapy (e.g., infliximab, adalimumab) or other biological treatment.
Key exclusion criteria (15 listed)
- Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease.
- Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
- Treatment naïve subject diagnosed with Ulcerative Colitis (without previous exposure to any of the following therapies for UC treatment: oral 5-ASA, corticosteroids, immunosuppressants, or biological treatments).
- Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
- Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
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 |
|---|---|---|
| SHR-1139 intravenous injection.SHR-1139 intravenous injection. | Drug | Treatment group A |
Primary outcome
The proportion of subjects who achieve clinical response (based on modified Mayo score) at week 12.
Time frame: at week 12.
5 secondary outcomes
The proportion of subjects who achieve clinical remission (based on modified Mayo score) at week 12 and week 60.
Time frame: at week 12 and week 60.
The proportion of subjects who achieve endoscopic improvement, endoscopic remission and systemic remission at week 12 and week 60.
Time frame: at week 12 and week 60.
The proportion of subjects who achieve clinical response (based on modified Mayo score) at week 60.
Time frame: at week 12 and week 60.
The proportion of subjects whose partial Mayo score ≤1 at each visit.
Time frame: at week 4, 8, 12, 22, 36, 42 and week 60.
The proportion of subjects whose total Mayo score ≤2 and no individual sub-score >1 at week 12 and week 60.
Time frame: at week 12 and week 60.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 SHR-1139 intravenous injection. in people with Adult Patients With Moderately to Severely Active Ulcerative Colitis, run by Guangdong Hengrui Pharmaceutical 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 7 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
The proportion of subjects who achieve clinical response (based on modified Mayo score) at week 12. (time frame: at 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 4 Jun 2026.