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

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 2

Conditions: Adult Patients With Moderately to Severely Active Ulcerative Colitis

Treatments: Drug: HRS-7085; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229950

HRS-7085-201

Details and patient eligibility

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 3 patient groups, including a placebo group

Treatment group A: HRS-7085 Low dose

Experimental group

Treatment:

Drug: HRS-7085

Drug: HRS-7085

Treatment group B: HRS-7085 High dose

Experimental group

Treatment:

Drug: HRS-7085

Drug: HRS-7085

Treatment group C: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo