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

ClinicalTrials.gov ID: NCT05181137

Public ClinicalTrials.gov record NCT05181137. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced May 3, 2026, 11:35 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Study identification

NCT ID: NCT05181137
Recruitment status: Not listed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Reistone Biopharma Company Limited; Industry
Enrollment: 368 participants

Conditions and interventions

Conditions

Ulcerative Colitis

Interventions

Placebo Drug
SHR0302 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 4, 2021
Primary completion: Oct 30, 2024
Completion: Mar 30, 2025
Last update posted: Sep 4, 2023

2021 – 2025

United States locations

U.S. sites: 23
U.S. states: 15
U.S. cities: 22

Facility	City	State	ZIP	Site status
Digestive Health Specialists	Dothan	Alabama	36301	Completed
Om Research LLC	Lancaster	California	93534	Terminated
Yale University	New Haven	Connecticut	06510	Terminated
IHS Health	Kissimmee	Florida	34741	Active, not recruiting
Dade Research Center	Miami	Florida	33126	Terminated
Gastro Florida	Pinellas Park	Florida	33781	Completed
One Health Research Clinic Atlanta, LLC	Norcross	Georgia	30039	Active, not recruiting
John Hopkins University	Columbia	Maryland	21045	Terminated
Michigan Medical	Ann Arbor	Michigan	48109	Terminated
Research Institute of Michigan	Chesterfield	Michigan	48047	Withdrawn
NY Scientific	Brooklyn	New York	11235	Terminated
DiGiovanna Institute for Medical Education & Research	North Massapequa	New York	11758	Terminated
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27599	Terminated
Charlotte Gastroenterology & Hepatology P.L.L.C	Charlotte	North Carolina	28207	Withdrawn
DDSI	Oklahoma City	Oklahoma	73112	Withdrawn
Central Sooner Research	Oklahoma City	Oklahoma	73118	Terminated
Vanderbilt University Medical Center	Nashville	Tennessee	37204	Terminated
Omni Clinical Research	Houston	Texas	77034	Terminated
UTMB Health	League City	Texas	77573	Terminated
University of Utah	Salt Lake City	Utah	84132	Terminated
McGuire Research Institute	Richmond	Virginia	23249	Terminated
IACT Health	Suffolk	Virginia	23435	Withdrawn
Advocate Aurora Health - Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	53215	Terminated

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 90 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05181137, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 4, 2023 · Synced May 3, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05181137 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →