HRS-7085 tablets for adults with moderate to severe ulcerative colitis

A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease

This phase 2 trial will test whether HRS-7085 tablets help adults with moderate to severe ulcerative colitis reduce inflammation and symptoms compared with placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: infliximab, adalimumab
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07229950 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial with screening, a treatment period, and follow-up to measure efficacy, safety, and pharmacokinetics of oral HRS-7085. Participants must have moderately to severely active ulcerative colitis confirmed by a 9-point modified Mayo score and a central endoscopic read. The trial compares HRS-7085 to placebo and collects clinical scores, endoscopy findings, safety labs, and drug concentration data. Eligible patients have prior inadequate response or intolerance to conventional or biologic/JAK treatments and will be monitored for symptom improvement and adverse events.

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, rectal bleeding ≥1), with at least 90 days since diagnosis and prior inadequate response or intolerance to conventional or biologic/JAK therapies are ideal candidates.

Not a fit: People with mild ulcerative colitis, those outside the specified severity or age range, pregnant or breastfeeding individuals, or those unable to meet contraception requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HRS-7085 could offer an additional oral option that reduces symptoms and mucosal inflammation for people with moderate to severe ulcerative colitis.

How similar studies have performed: Other oral small-molecule drugs such as JAK inhibitors have shown benefit in ulcerative colitis, but HRS-7085 is a new agent that has not yet been proven effective for this condition.

Eligibility criteria

Inclusion Criteria:

1. Male and female subject age ≥ 18，≤75.
2. the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ².
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), 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 to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or anti-TNF therapy (e.g., infliximab, adalimumab) or other biological, or JAK inhibitors 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 a highly effective contraception to 3 months 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.
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. 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.

   8.4Any 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

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Tingyu Dong

Conditions Adult Patients With Moderately to Severely Active Ulcerative Colitis