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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-7085 Low dose | Experimental |
| |
| Treatment group B: HRS-7085 High dose | Experimental |
| |
| Treatment group C: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7085 | Drug | HRS-7085 Low dose po |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects experiencing at least one Adverse Event | at Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving clinical response | at Week 8 | |
| Proportion of subjects achieving symptomatic remission, | at Week 8 | |
| Proportion of subjects achieving clinical remission |
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Inclusion Criteria:
Exclusion Criteria:
Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease.
Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
Treatment naïve subject diagnosed with Ulcerative Colitis.
Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
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.
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.
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingyu Dong | Contact | 0518-82342973 | tingyu.dong@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610044 | China |
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| HRS-7085 |
| Drug |
HRS-7085 High dose po |
|
| Placebo | Drug | Placebo po |
|
| 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 |
| Peak Plasma Concentrations (Cmax) | at Week 4 |
| Area Under the Curve (AUC) of Plasma Concentrations | at Week 4 |