RecruitingPhase 2NCT07229950

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


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

66 participants

Start Date

Oct 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new pill called HRS-7085 for people with moderate-to-severe ulcerative colitis — a condition that causes long-term inflammation and sores in the large intestine. Researchers want to see if this drug is safe and effective. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with ulcerative colitis for at least 90 days - Your disease is currently active and causing symptoms (including rectal bleeding) - Previous treatments like steroids, immunosuppressants, or biologic drugs have not worked well enough **You may NOT be eligible if...** - You are under 18 or over 75 years old - You are underweight (BMI below 18) - Your colitis is not currently active - You have Crohn's disease rather than ulcerative colitis - You have a serious infection, liver disease, or other major health problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-7085

HRS-7085 Low dose po

DRUGHRS-7085

HRS-7085 High dose po

DRUGPlacebo

Placebo po


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT07229950


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