A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Table… (NCT07229950) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
China48 participantsStarted 2025-10-17
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects experiencing at least one Adverse Event
. 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
. 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.
. 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.
. 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.