SHR-1139 treatment for adults with moderate-to-severe 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.

This trial will try intravenous SHR-1139 in adults with moderate-to-severe ulcerative colitis to see if it reduces disease activity and is safe.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Drugs / interventions: infliximab, adalimumab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07232576 on ClinicalTrials.gov

What this trial studies

This is a phase 2, single-center interventional study testing intravenous SHR-1139 in adults with moderately to severely active ulcerative colitis. The study includes a 12-week induction period followed by a 48-week maintenance period, with efficacy, safety, and pharmacokinetics as key outcomes. Eligible participants are 18–75 years old with a modified Mayo score of 4–9 and an endoscopic subscore ≥2, and have had inadequate response or intolerance to conventional therapy or prior biologic exposure. Treatment is administered by IV injection and central endoscopic reads are used to confirm baseline disease activity.

Who should consider this trial

Good fit: Adults aged 18–75 with moderately to severely active ulcerative colitis (modified Mayo score 4–9, endoscopic subscore ≥2) who have failed, lost response to, or are intolerant of conventional treatments or have prior biologic exposure.

Not a fit: Patients with mild disease, a very recent diagnosis, contraindications to IV therapy, or who do not meet the study's eligibility criteria are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, SHR-1139 could offer a new therapeutic option that reduces inflammation and helps maintain remission with an acceptable safety profile.

How similar studies have performed: Other biologic and targeted therapies have demonstrated benefit in moderate-to-severe ulcerative colitis, but SHR-1139 is a newer agent with limited published clinical data so far.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital,Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Tingyu Dong

Conditions Adult Patients With Moderately to Severely Active Ulcerative Colitis