Actively Recruiting
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-02-06
66
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Body mass index (BMI) of at least 18 kg/m�b2
- Active ulcerative colitis with a 9-point modified Mayo score of 4 to 9, endoscopic subscore �b12, and rectal bleeding subscore of 1 or more
- Ulcerative colitis diagnosis for at least 90 days prior to baseline
- Inadequate response, loss of response, or intolerance to at least one conventional treatment (oral 5-ASA, immunosuppressants, corticosteroids), anti-TNF therapy, other biologicals, or JAK inhibitors
- Ability to provide signed informed consent
- Women of childbearing potential and their male partners must agree to use highly effective contraception through 3 months after last dose
You will not qualify if you...
- Diagnosis of indeterminate colitis or signs suggestive of Crohn's disease
- Ulcerative colitis limited to proctitis (distal 15 cm or less)
- Treatment-na�efve ulcerative colitis patients
- Signs of ischemic colitis, fulminant colitis, or toxic megacolon
- Previous ulcerative colitis surgery or likely need for surgery during study
- History of gastrointestinal dysplasia or cancer except completely resected low-grade dysplasia
- Evidence of pathogenic bowel infection, including recent Clostridium difficile or other intestinal infections
- Recent significant infections or history of multiple herpes zoster episodes
- Current or recent use of cyclosporine, mycophenolate, tacrolimus, JAK inhibitors, interferon therapy, or corticosteroids within specified timeframes before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
Research Team
T
Tingyu Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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