A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
Phase 2 · Testing HRS-7085 · 1 site · Shandong Suncadia Medicine Co., Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing HRS-7085 (a drug) and HRS-7085 (a drug) as a possible treatment. Condition(s) listed: Adult Patients With Moderately to Severely Active Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Male and female subject age ≥ 18,≤75.
- the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ².
- 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.
Plus 4 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 48 participants are expected to take part.
- Start date: 2025-10-17.
- Main results expected around 2026-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Proportion of subjects experiencing at least one Adverse Event (at Week 14)
In the researchers’ words
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Adult Patients With Moderately to Severely Active Ulcerative Colitis |
| Lead sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Enrollment | 48 (estimated) |
| Start date | 2025-10-17 |
| Primary completion (est.) | 2026-12 |
| First posted | 2025-11-17 |
| Last updated | 2026-06-02 |
| Official title | A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07229950 |
Interventions
- HRS-7085 (Drug)
HRS-7085 Low dose po - HRS-7085 (Drug)
HRS-7085 High dose po - Placebo (Drug)
Placebo po
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu, Sichuan | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.