NCT05181137|UnknownPhase 3DMCFDA Drug

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

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

Reistone Biopharma Company Limited ClinicalTrials.gov

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1 other identifier

RSJ10135

Study Type

interventional

Target

368

Locations

5 countries

Sites

113

Timeline

RegisteredJan 2022

StartedNov 2021

CompletionMar 2025

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

368

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2021

Typical duration for phase_3

Geographic Reach

5 countries

113 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.4 years study duration

Study Start

First participant enrolled

November 5, 2021

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2021

Completed

27 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed

Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

December 10, 2021

Last Update Submit

September 1, 2023

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

Clinical remission at week 8 (Part 1)
The percentage of subjects in clinical remission at week 8.
8 weeks
Clinical remission at week 52 (Part 2)
The percentage of subjects in clinical remission at week 52.
52 weeks

Secondary Outcomes (13)

Endoscopic remission at week 8 (Part 1)
8 weeks
Clinical response at week 8 (Part 1)
8 weeks
Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1)
8 weeks
Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1)
8 weeks
Subjects with endoscopic remission (Part 2)
52 weeks
+8 more secondary outcomes

Study Arms (5)

Part 1 Active Experimental: SHR0302 Dose#1

EXPERIMENTAL

SHR0302 Oral tablets taken once daily (QD) for 8 weeks SHR0302 Oral tablets taken once daily (QD)

Drug: SHR0302

Part 1 Placebo Comparator: Placebo

PLACEBO COMPARATOR

Placebo Oral tablets taken once daily (QD) for 8 weeks

Drug: Placebo

Part 2 Active Experimental: SHR0302 Dose#2

EXPERIMENTAL

SHR0302 Oral tablets taken once daily (QD) for 44 weeks

Drug: SHR0302

Part 2 Placebo Comparator: Placebo

PLACEBO COMPARATOR

Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo

Drug: Placebo

Part 3 Active Experimental: SHR0302 Dose#2

EXPERIMENTAL

SHR0302 Oral tablets taken once daily (QD) for 26 weeks

Drug: SHR0302

Interventions

SHR0302DRUG

Oral tablets taken once daily (QD)

Part 1 Active Experimental: SHR0302 Dose#1Part 2 Active Experimental: SHR0302 Dose#2Part 3 Active Experimental: SHR0302 Dose#2

PlaceboDRUG

Oral tablets taken once daily (QD)

Part 1 Placebo Comparator: PlaceboPart 2 Placebo Comparator: Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects must be at least at ≥18 and ≤75 years of age
Subject has at least a three-month history of Ulcerative Colitis diagnosis at baseline.
Subject has active Ulcerative Colitis with a 9-point modified Mayo score of ≥ 5 at baseline, with an endoscopic subscore of ≥ 2
Subject is deemed by the physician as having inadequate response, loss of response or intolerance to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or was previously exposed to anti-TNF therapy (e.g., infliximab, adalimumab) or other biological treatment (e.g., vedolizumab) having
Discontinued the treatment for:
Infliximab: a minimum of 8 weeks prior to baseline.
Adalimumab: a minimum of 10 weeks prior to baseline.
Ustekinumab: a minimum of 14 weeks prior to baseline.
Vedolizumab: a minimum of 17 weeks prior to baseline.
\. Subject has completed the 8-week Part 1 and was classified as not meeting clinical response criteria. OR Subject has discontinued treatment early in the Maintenance phase due to disease worsening OR Subject has completed the Maintenance phase.

You may not qualify if:

Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn'sDisease.
Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
Treatment naïve subject diagnosed with Ulcerative Colitis (without previous exposure to any of the following therapies for UC treatment: oral 5-ASA, corticosteroids, immunosuppressants, or biological treatments).
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.
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 has a history of active tuberculosis (TB) or latent TB infection.
Subject is receiving any of the following therapies:
Azathioprine/6-mercaptopurine, methotrexate, thalidomide within 7 days prior to baseline.
Cyclosporine, mycophenolate, tacrolimus within 4 weeks prior to baseline.
Interferon therapy within 8 weeks prior to baseline.
Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5- ASA within 2 weeks prior to baseline.
Subject had any prior treatment with lymphocyte-depleting agents/therapies (such as CamPath® \[alemtuzumab\], alkylating agents \[e.g., cyclophosphamide or chlorambucil\], total lymphoid irradiation, etc.). Subjects who have received rituximab or other selective B lymphocyte depleting agents are eligible if they have not received such therapy for at least 1 year prior to baseline.
Subject has previously received JAK inhibitors, such as tofacitinib, baricitinib, upadacitinib, filgotinib.
Subject with evidence of clinically relevant laboratory abnormalities which may affect subject safety or interpretation of study results at screening
+18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Reistone Biopharma Company Limitedlead

Study Sites (113)

Digestive Health Specialists

Dothan, Alabama, 36301, United States

COMPLETED

Om Research LLC

Lancaster, California, 93534, United States

TERMINATED

Yale University

New Haven, Connecticut, 06510, United States

TERMINATED

IHS Health

Kissimmee, Florida, 34741, United States

ACTIVE NOT RECRUITING

Dade Research Center

Miami, Florida, 33126, United States

TERMINATED

Gastro Florida

Pinellas Park, Florida, 33781, United States

COMPLETED

One Health Research Clinic Atlanta, LLC

Norcross, Georgia, 30039, United States

ACTIVE NOT RECRUITING

John Hopkins University

Columbia, Maryland, 21045, United States

TERMINATED

Michigan Medical

Ann Arbor, Michigan, 48109, United States

TERMINATED

Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

WITHDRAWN

NY Scientific

Brooklyn, New York, 11235, United States

TERMINATED

DiGiovanna Institute for Medical Education & Research

North Massapequa, New York, 11758, United States

TERMINATED

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

TERMINATED

Charlotte Gastroenterology & Hepatology P.L.L.C

Charlotte, North Carolina, 28207, United States

WITHDRAWN

DDSI

Oklahoma City, Oklahoma, 73112, United States

WITHDRAWN

Central Sooner Research

Oklahoma City, Oklahoma, 73118, United States

TERMINATED

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

TERMINATED

Omni Clinical Research

Houston, Texas, 77034, United States

TERMINATED

UTMB Health

League City, Texas, 77573, United States

TERMINATED

University of Utah

Salt Lake City, Utah, 84132, United States

TERMINATED

McGuire Research Institute

Richmond, Virginia, 23249, United States

TERMINATED

IACT Health

Suffolk, Virginia, 23435, United States

WITHDRAWN

Advocate Aurora Health - Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

TERMINATED

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Beijing Military Area General Hospital/Seventh Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

TERMINATED

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Tsinghua University Changgung Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Army Medical Center of PLA

Chongqing, Chongqing Municipality, China

RECRUITING

Chongqing People's Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospitial of Xiamen University

Xiamen, Fujian, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technoloy

Luoyang, Henan, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Hena, China

RECRUITING

Jingzhou First People's Hospital

Jingzhou, Hubei, China

RECRUITING

Affiliated Taihe Hospital of Hubei University of Medicine

Shiyan, Hubei, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

RECRUITING

Zhuzhou Central Hospital

Zhuzhou, Hunan, China

RECRUITING

Baotou Central Hospital

Baotou, Inner Mongolia, China

RECRUITING

Huai'an First People's Hospital

Huai'an, Jiangsu, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, China

RECRUITING

Nanjing General Hospital of Nanjing Military Command

Nanjing, Jiangsu, China

RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Subei People's Hospital of Jiangsu province

Yangzhou, Jiangsu, China

RECRUITING

Shengjing Hospital Of China Medical University

Shenyang, Liaoning, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

TERMINATED

Binzhou Medical University Hospital

Binzhou, Shandong, China

RECRUITING

Liaocheng People's Hospital

Liaocheng, Shandong, China

RECRUITING

Huashan Hospital, Fudan University