Trials / Completed
CompletedNCT03675477
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Reistone Biopharma Company Limited · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients. This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase can not enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks. SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation. Therefore it has the potential to be a treatment for ulcerative colitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR0302 | The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a Janus kinase inhibitor). |
| DRUG | Placebo | Placebo Oral Tablet |
Timeline
- Start date
- 2019-04-13
- Primary completion
- 2020-11-30
- Completion
- 2021-02-03
- First posted
- 2018-09-18
- Last updated
- 2023-06-02
- Results posted
- 2022-11-22
Locations
67 sites across 5 countries: United States, China, Poland, Puerto Rico, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03675477. Inclusion in this directory is not an endorsement.