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A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

NCT03675477 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2023-06-02

Study results available
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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 Early withdrawn subjects during the first treatment phase can not enter the extension phase.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

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

Sponsors & Collaborators

  • Reistone Biopharma Company Limited

    lead INDUSTRY

Principal Investigators

  • Xiang Chen · Reistone Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-13
Primary Completion
2020-11-30
Completion
2021-02-03
FDA Drug
Yes

Countries

  • United States
  • China
  • Poland
  • Puerto Rico
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675477 on ClinicalTrials.gov