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

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.

Study Overview

• Status: Recruiting
• Conditions: Adult Patients With Moderately to Severely Active Ulcerative Colitis
• Intervention / Treatment: Drug: HRS-7085; Drug: HRS-7085; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tingyu Dong; Phone Number: 0518-82342973; Email: tingyu.dong@hengrui.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • Recruiting
      • West China Hospital of Sichuan University
      • Principal Investigator: Yufang Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-7085 Low dose	Drug: HRS-7085; HRS-7085 Low dose po; Drug: HRS-7085; HRS-7085 High dose po
Experimental: Treatment group B: HRS-7085 High dose	Drug: HRS-7085; HRS-7085 Low dose po; Drug: HRS-7085; HRS-7085 High dose po
Placebo Comparator: Treatment group C: Placebo	Drug: Placebo; Placebo po

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects experiencing at least one Adverse Event	at Week 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentrations (Cmax)	at Week 4
Area Under the Curve (AUC) of Plasma Concentrations	at Week 4
Proportion of subjects achieving clinical response	at Week 8
Proportion of subjects achieving symptomatic remission,	at Week 8
Proportion of subjects achieving clinical remission	at Week 8
Change from baseline in partial Mayo score,	at week8、week12
Change from baseline in EQ-5D-5L (5-Level EuroQol 5-Dimension) index score,	at Week 8

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HRS-7085-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No