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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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 to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With moderate-to- Severe Active Ulcerative Colitis.

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis (NCT07232576) is a Phase 2 interventional studying Adult Patients With Moderately to Severely Active Ulcerative Colitis, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Adult Patients With Moderately to Severely Active Ulcerative Colitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male and female subject age ≥ 18 and ≤ 75 years of age at screening. 2. the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ² at the screening. 3. 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. 4. Subject has at least a 90-days history of Ulcerative Colitis diagnosis at baseline. 5. 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. 6. Subject is capable of providing a signed and dated willing to sign a consent form form indicating the subject has been informed of all pertinent aspects of the study. 7. 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 Should NOT Join This Trial: 1. Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease. 2. Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less). 3. 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). 4. Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon. 5. Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male and female subject age ≥ 18 and ≤ 75 years of age at screening. 2. the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ² at the screening. 3. 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. 4. Subject has at least a 90-days history of Ulcerative Colitis diagnosis at baseline. 5. 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. 6. 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. 7. 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. Exclusion Criteria: 1. Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease. 2. Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less). 3. 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). 4. Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon. 5. Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period. 6. 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. 7. 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. 8. 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. 9. 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.

Treatments Being Tested

DRUG

SHR-1139 intravenous injection.

SHR-1139 intravenous injection.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07232576), the sponsor (Guangdong Hengrui Pharmaceutical Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07232576 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07232576?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07232576?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07232576. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07232576. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.