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

NCT ID: NCT07229950

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-03-31

Brief 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.

Conditions

Adult Patients With Moderately to Severely Active Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A: HRS-7085 Low dose

Group Type: EXPERIMENTAL

HRS-7085

Intervention Type: DRUG

HRS-7085 Low dose po

Treatment group B: HRS-7085 High dose

Group Type: EXPERIMENTAL

HRS-7085

Intervention Type: DRUG

HRS-7085 High dose po

Treatment group C: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo po

Interventions

HRS-7085

HRS-7085 Low dose po

Intervention Type: DRUG

HRS-7085

HRS-7085 High dose po

Intervention Type: DRUG

Placebo

Placebo po

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female subject age ≥ 18.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Tingyu Dong

Role: CONTACT

tingyu.dong@hengrui.com

0518-82342973

Other Identifiers

HRS-7085-201

Identifier Type: -

Identifier Source: org_study_id