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A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis

NCT05181137 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2023-09-05

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.

Conditions

Interventions

DRUG

SHR0302

Oral tablets taken once daily (QD)

DRUG

Placebo

Oral tablets taken once daily (QD)

Sponsors & Collaborators

  • Reistone Biopharma Company Limited

    lead INDUSTRY

Principal Investigators

  • Xiang Chen · Reistone Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2024-10-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States
  • China
  • Georgia
  • Poland
  • Ukraine

Study Locations

More Related Trials

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 NCT05181137 on ClinicalTrials.gov