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

May 31, 2026 updated by: Shandong Suncadia Medicine Co., Ltd.
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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