RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-11-05

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05181137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female subjects must be at least at ≥18 and ≤75 years of age 2. Subject has at least a three-month history of Ulcerative Colitis diagnosis at baseline. 3. Subject has active Ulcerative Colitis with a 9-point modified Mayo score of ≥ 5 at baseline, with an endoscopic subscore of ≥ 2 4. 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 * 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. 1. 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.	1. Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn'sDisease. 2. Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less). 3. 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). 4. Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon. 5. Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period. 6. 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. 7. Subject currently has or has a history of active tuberculosis (TB) or latent TB infection. 8. 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. 9. 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. 10. Subject has previously received JAK inhibitors, such as tofacitinib, baricitinib, upadacitinib, filgotinib. 11. Subject with evidence of clinically relevant laboratory abnormalities which may affect subject safety or interpretation of study results at screening 12. Subject has a screening 12-lead ECG that demonstrates clinically relevant abnormalities 13. Subject currently has or had: * A clinically significant infection within 1 month of baseline (e.g., those requiring hospitalization or parenteral antimicrobial therapy or have opportunistic infections). * A history of more than one episode of herpes zoster, or disseminated zoster (single episode). * Any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study. * Any infection requiring antimicrobial therapy within 2 weeks of screening. 14. Subject has current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline. 15. Subject with a first-degree relative with a hereditary immunodeficiency. 16. Subject with a history of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder, as reported in some subjects on other immunosuppressive drugs), history of lymphoma, leukemia, multiple myeloma, or signs and symptoms that are suggestive of current lymphatic disease. 17. Subject has any condition possibly affecting oral drug absorption e.g., gastrectomy, or clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. (Procedures such as gastric banding, gastric balloon that simply divide stomach into separate chambers, are NOT exclusionary.) Subject has undergone significant trauma or major surgery within 4 weeks of baseline. 18. Women who are pregnant or lactating, or planning pregnancy while enrolled in the study. Male who plan to donate sperm during the study and within 30 days after the last dose of study drug. 19. Subject who has a history of alcohol or drug abuse with less than 6 months of abstinence prior to baseline that in the opinion of the investigator will preclude participation in the study. 20. Subject with malignancies or with a history of malignancies with exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin. 21. Subject infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses. 22. Subject has received any investigational drug or device within 3 months, or 5 half-lives (if known) prior to baseline. 23. Subject is receiving or expected to receive prohibited concomitant medication(s) in the 4 weeks prior to the first dose of study drug and through follow-up visit. 24. Any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion in the study. 25. Subject with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease), or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. 26. Subject with a history of thromboembolic events, including deep vein thromboses (DVT), pulmonary embolism (PE), and those with known inherited conditions that predispose to hypercoagulability. 1. Subject with any clinically significant condition at the end of 8-week Induction treatment from Part 1 Induction phase, and Part 2 Maintenance Phase that in the opinion of investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis. 2. Subject who, in the opinion of the investigator or sponsor, is unlikely to be cooperative or able to comply with study procedures, or any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion.

Inclusion Criteria

Exclusion Criteria

1. Male or female subjects must be at least at ≥18 and ≤75 years of age
2. Subject has at least a three-month history of Ulcerative Colitis diagnosis at baseline.
3. Subject has active Ulcerative Colitis with a 9-point modified Mayo score of ≥ 5 at baseline, with an endoscopic subscore of ≥ 2
4. 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
* 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.
1. 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.

1. Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn'sDisease.
2. Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
3. 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).
4. Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
5. Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
6. 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.
7. Subject currently has or has a history of active tuberculosis (TB) or latent TB infection.
8. 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.
9. 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.
10. Subject has previously received JAK inhibitors, such as tofacitinib, baricitinib, upadacitinib, filgotinib.
11. Subject with evidence of clinically relevant laboratory abnormalities which may affect subject safety or interpretation of study results at screening
12. Subject has a screening 12-lead ECG that demonstrates clinically relevant abnormalities
13. Subject currently has or had:
* A clinically significant infection within 1 month of baseline (e.g., those requiring hospitalization or parenteral antimicrobial therapy or have opportunistic infections).
* A history of more than one episode of herpes zoster, or disseminated zoster (single episode).
* Any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
* Any infection requiring antimicrobial therapy within 2 weeks of screening.
14. Subject has current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline.
15. Subject with a first-degree relative with a hereditary immunodeficiency.
16. Subject with a history of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder, as reported in some subjects on other immunosuppressive drugs), history of lymphoma, leukemia, multiple myeloma, or signs and symptoms that are suggestive of current lymphatic disease.
17. Subject has any condition possibly affecting oral drug absorption e.g., gastrectomy, or clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. (Procedures such as gastric banding, gastric balloon that simply divide stomach into separate chambers, are NOT exclusionary.) Subject has undergone significant trauma or major surgery within 4 weeks of baseline.
18. Women who are pregnant or lactating, or planning pregnancy while enrolled in the study. Male who plan to donate sperm during the study and within 30 days after the last dose of study drug.
19. Subject who has a history of alcohol or drug abuse with less than 6 months of abstinence prior to baseline that in the opinion of the investigator will preclude participation in the study.
20. Subject with malignancies or with a history of malignancies with exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin.
21. Subject infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
22. Subject has received any investigational drug or device within 3 months, or 5 half-lives (if known) prior to baseline.
23. Subject is receiving or expected to receive prohibited concomitant medication(s) in the 4 weeks prior to the first dose of study drug and through follow-up visit.
24. Any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion in the study.
25. Subject with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease), or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
26. Subject with a history of thromboembolic events, including deep vein thromboses (DVT), pulmonary embolism (PE), and those with known inherited conditions that predispose to hypercoagulability.
1. Subject with any clinically significant condition at the end of 8-week Induction treatment from Part 1 Induction phase, and Part 2 Maintenance Phase that in the opinion of investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis.
2. Subject who, in the opinion of the investigator or sponsor, is unlikely to be cooperative or able to comply with study procedures, or any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion.

Contacts and Locations

Study Contact

Minna Sun

CONTACT

+86 18611785877

minna.sun@reistonebio.com

Lingyu Guo

CONTACT

+86 13311061570

lingyu.guo@reistonebio.com

Principal Investigator

Xiang Chen

STUDY_DIRECTOR

Reistone Pharma

Study Locations (Sites)

Digestive Health Specialists

Dothan, Alabama, 36301

United States

Om Research LLC

Lancaster, California, 93534

United States

Yale University

New Haven, Connecticut, 06510

United States

IHS Health

Kissimmee, Florida, 34741

United States

Dade Research Center

Miami, Florida, 33126

United States

Gastro Florida

Pinellas Park, Florida, 33781

United States

One Health Research Clinic Atlanta, LLC

Norcross, Georgia, 30039

United States

John Hopkins University

Columbia, Maryland, 21045

United States

Michigan Medical

Ann Arbor, Michigan, 48109

United States

Research Institute of Michigan

Chesterfield, Michigan, 48047

United States

NY Scientific

Brooklyn, New York, 11235

United States

DiGiovanna Institute for Medical Education & Research

North Massapequa, New York, 11758

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Charlotte Gastroenterology & Hepatology P.L.L.C

Charlotte, North Carolina, 28207

United States

DDSI

Oklahoma City, Oklahoma, 73112

United States

Central Sooner Research

Oklahoma City, Oklahoma, 73118

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37204

United States

Omni Clinical Research

Houston, Texas, 77034

United States

UTMB Health

League City, Texas, 77573

United States

University of Utah

Salt Lake City, Utah, 84132

United States

McGuire Research Institute

Richmond, Virginia, 23249

United States

IACT Health

Suffolk, Virginia, 23435

United States

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

Milwaukee, Wisconsin, 53215

United States

Collaborators and Investigators

Sponsor: Reistone Biopharma Company Limited

Xiang Chen, STUDY_DIRECTOR, Reistone Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-05

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2021-11-05

Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

Ulcerative Colitis