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

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SHR0302
Placebo
Sponsored by
Reistone Biopharma Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion Criteria for Part 1

  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

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.

Inclusion Criteria for Part 2 1. Subject has completed Part 1 and achieved clinical response at week 8

Inclusion Criteria for Part 3

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.

Study Exclusion Criteria for Part 1

Exclusion Criteria:

  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.

Study Exclusion Criteria for Parts 2 and 3

  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.

Sites / Locations

  • Digestive Health Specialists
  • Om Research LLC
  • Yale University
  • IHS Health
  • Dade Research Center
  • Gastro Florida
  • One Health Research Clinic Atlanta, LLC
  • John Hopkins University
  • Michigan Medical
  • Research Institute of Michigan
  • NY Scientific
  • DiGiovanna Institute for Medical Education & Research
  • University of North Carolina at Chapel Hill
  • Charlotte Gastroenterology & Hepatology P.L.L.C
  • DDSI
  • Central Sooner Research
  • Vanderbilt University Medical Center
  • Omni Clinical Research
  • UTMB Health
  • University of Utah
  • McGuire Research Institute
  • IACT Health
  • Advocate Aurora Health - Aurora St. Luke's Medical Center
  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Anhui Provincial HospitalRecruiting
  • Beijing Military Area General Hospital/Seventh Medical Center of PLA General HospitalRecruiting
  • Peking University First Hospital
  • Peking University Third HospitalRecruiting
  • Tsinghua University Changgung Hospital
  • Army Medical Center of PLARecruiting
  • Chongqing People's HospitalRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • The First Affiliated Hospitial of Xiamen UniversityRecruiting
  • Guangzhou First People's HospitalRecruiting
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • The Sixth Affiliated Hospital of Sun Yat-Sen UniversityRecruiting
  • Third Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Peking University Shenzhen HospitalRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • The First Affiliated Hospital of Henan University of Science and TechnoloyRecruiting
  • Henan Provincial People's HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The Second Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Jingzhou First People's HospitalRecruiting
  • Affiliated Taihe Hospital of Hubei University of MedicineRecruiting
  • Renmin Hospital of Wuhan University
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • Zhuzhou Central HospitalRecruiting
  • Baotou Central HospitalRecruiting
  • Huai'an First People's HospitalRecruiting
  • Jiangsu Province Hospital
  • Nanjing First HospitalRecruiting
  • Nanjing General Hospital of Nanjing Military CommandRecruiting
  • Zhongda Hospital Southeast UniversityRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Subei People's Hospital of Jiangsu provinceRecruiting
  • Shengjing Hospital Of China Medical UniversityRecruiting
  • The First Hospital of China Medical University
  • Binzhou Medical University HospitalRecruiting
  • Liaocheng People's HospitalRecruiting
  • Huashan Hospital, Fudan UniversityRecruiting
  • Longhua Hospital Shanghai University of Traditional Chinese Medicine
  • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting
  • Shanghai Changhai HospitalRecruiting
  • Shanghai East Hospital
  • Shanghai General Hospital
  • Shanghai Sixth People's Hospital
  • Zhongshan Hospital Affiliated to Fudan UniversityRecruiting
  • Shanxi Provincial People's Hospital
  • The First Hospital of Shanxi Medical UniversityRecruiting
  • West China Hospital Sichuan UniversityRecruiting
  • Tianjin medical University General HospitalRecruiting
  • Tianjin Union Medical CenterRecruiting
  • The First Affiliated Hospital of Zhejiang University of Traditional Chinese MedicineRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Jinhua Municipal Central HospicalRecruiting
  • Ningbo First HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Curatio, Jsc
  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
  • LTD Central University Clinic After Academic N. Kipshidze
  • LTD The First Medical Center
  • CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
  • MZ BADANIA Slowik Zymla General Partnership
  • "Landa" Specialist Doctor's Offices
  • PLEJADY Medical Centre
  • AMED Medical Centre Branch in Lodz
  • Oswiecim Clinical Trial Centre
  • Private Healthcare Institution Specialist Clinics Termedica
  • Dariusz Kleczkowski Specialist Medical Practice
  • Torun Gastrology Centre "Gastromed"
  • MDM Healthcare Centre
  • WIP Warsaw IBD Point
  • Medical Centre Oporow
  • ETG Zamosc
  • Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
  • Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"
  • Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
  • Public Non-Profit Institution: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council
  • Public Non-Profit Enterprise "Khmelnytskyi Regional Hospital" under Khmelnytskyi Regional Council
  • Clinical Hospital "Feofaniia"
  • Medical Center "Consylium Medical"
  • Medical Center OK!Clinic+ of the Company with Limited Liability International Institute of Clinical Research
  • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
  • Public Non-Profit Enterprise under Sumy Regional Council "Sumy Regional Clinical Hospital"
  • Communal Non-Commercial Enterprise: Vinnytsia City Clinical Hospital #1
  • Public Non-Profit Enterprise "City Hospital #6" under Zaporizhia City Council
  • "Medibor Plus" Llc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1 Active Experimental: SHR0302 Dose#1

Part 1 Placebo Comparator: Placebo

Part 2 Active Experimental: SHR0302 Dose#2

Part 2 Placebo Comparator: Placebo

Part 3 Active Experimental: SHR0302 Dose#2

Arm Description

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

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

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

Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Endoscopic remission at week 8 (Part 1)
The percentage of subjects with endoscopic remission at week 8.
Clinical response at week 8 (Part 1)
The percentage of subjects with clinical response at week 8.
Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1)
Change from baseline in partial Mayo score at week 2, 4, and 8.
Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1)
Change in total Mayo score and 9-point modified Mayo score at week 8.
Subjects with endoscopic remission (Part 2)
The percentage of subjects with endoscopic remission at week 52.
Subjects with clinical response at week 52 (Part 2)
The percentage of subjects with clinical response at week 52.
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52 (Part 2)
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52.
Change in total Mayo score and 9-point modified Mayo score at week 52 (Part 2)
Change in total Mayo score and 9-point modified Mayo score at week 52.
Subjects in corticosteroid-free remission at week 52 (Part 2)
Percentage of subjects in corticosteroid-free remission at week 52.
Subjects who maintain clinical remission at week 52 (Part 2)
Percentage of subjects who maintain clinical remission at week 52
Subjects in clinical remission per partial Mayo score at week E26 (Part 3)
The percentage of subjects in clinical remission per partial Mayo score at week E26.
Subjects in corticosteroid-free remission per Partial Mayo score at week E26 (Part 3)
The percentage of subjects in corticosteroid-free remission per Partial Mayo score at week E26.
Change from baseline in Partial Mayo score at week E2, E12, and E26 (Part 3)
Change from baseline in Partial Mayo score at week E2, E12, and E26.

Full Information

First Posted
December 10, 2021
Last Updated
September 1, 2023
Sponsor
Reistone Biopharma Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05181137
Brief Title
A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reistone Biopharma Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study consists of a screening period followed by a placebo-controlled Part 1 phase and then a placebo-controlled Part 2 phase. An open label Part 3 phase is open to subjects who: complete the Part 2, are considered non-responders following the Part 1, or have disease worsening during Part 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
368 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Active Experimental: SHR0302 Dose#1
Arm Type
Experimental
Arm Description
SHR0302 Oral tablets taken once daily (QD) for 8 weeks SHR0302 Oral tablets taken once daily (QD)
Arm Title
Part 1 Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Oral tablets taken once daily (QD) for 8 weeks
Arm Title
Part 2 Active Experimental: SHR0302 Dose#2
Arm Type
Experimental
Arm Description
SHR0302 Oral tablets taken once daily (QD) for 44 weeks
Arm Title
Part 2 Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo
Arm Title
Part 3 Active Experimental: SHR0302 Dose#2
Arm Type
Experimental
Arm Description
SHR0302 Oral tablets taken once daily (QD) for 26 weeks
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
Oral tablets taken once daily (QD)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets taken once daily (QD)
Primary Outcome Measure Information:
Title
Clinical remission at week 8 (Part 1)
Description
The percentage of subjects in clinical remission at week 8.
Time Frame
8 weeks
Title
Clinical remission at week 52 (Part 2)
Description
The percentage of subjects in clinical remission at week 52.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Endoscopic remission at week 8 (Part 1)
Description
The percentage of subjects with endoscopic remission at week 8.
Time Frame
8 weeks
Title
Clinical response at week 8 (Part 1)
Description
The percentage of subjects with clinical response at week 8.
Time Frame
8 weeks
Title
Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1)
Description
Change from baseline in partial Mayo score at week 2, 4, and 8.
Time Frame
8 weeks
Title
Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1)
Description
Change in total Mayo score and 9-point modified Mayo score at week 8.
Time Frame
8 weeks
Title
Subjects with endoscopic remission (Part 2)
Description
The percentage of subjects with endoscopic remission at week 52.
Time Frame
52 weeks
Title
Subjects with clinical response at week 52 (Part 2)
Description
The percentage of subjects with clinical response at week 52.
Time Frame
52 weeks
Title
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52 (Part 2)
Description
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52.
Time Frame
52 weeks
Title
Change in total Mayo score and 9-point modified Mayo score at week 52 (Part 2)
Description
Change in total Mayo score and 9-point modified Mayo score at week 52.
Time Frame
52 weeks
Title
Subjects in corticosteroid-free remission at week 52 (Part 2)
Description
Percentage of subjects in corticosteroid-free remission at week 52.
Time Frame
52 weeks
Title
Subjects who maintain clinical remission at week 52 (Part 2)
Description
Percentage of subjects who maintain clinical remission at week 52
Time Frame
52 weeks
Title
Subjects in clinical remission per partial Mayo score at week E26 (Part 3)
Description
The percentage of subjects in clinical remission per partial Mayo score at week E26.
Time Frame
26 weeks (extension)
Title
Subjects in corticosteroid-free remission per Partial Mayo score at week E26 (Part 3)
Description
The percentage of subjects in corticosteroid-free remission per Partial Mayo score at week E26.
Time Frame
26 weeks (extension)
Title
Change from baseline in Partial Mayo score at week E2, E12, and E26 (Part 3)
Description
Change from baseline in Partial Mayo score at week E2, E12, and E26.
Time Frame
26 weeks (extension)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for Part 1 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. Inclusion Criteria for Part 2 1. Subject has completed Part 1 and achieved clinical response at week 8 Inclusion Criteria for Part 3 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. Study Exclusion Criteria for Part 1 Exclusion Criteria: 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 Subject has a screening 12-lead ECG that demonstrates clinically relevant abnormalities 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. Subject has current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline. Subject with a first-degree relative with a hereditary immunodeficiency. 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. 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. 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. 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. 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. Subject infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses. Subject has received any investigational drug or device within 3 months, or 5 half-lives (if known) prior to baseline. 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. Any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion in the study. 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. 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. Study Exclusion Criteria for Parts 2 and 3 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minna Sun
Phone
+86 18611785877
Email
minna.sun@reistonebio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lingyu Guo
Phone
+86 13311061570
Email
lingyu.guo@reistonebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Chen
Organizational Affiliation
Reistone Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Individual Site Status
Completed
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Terminated
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Terminated
Facility Name
IHS Health
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dade Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Terminated
Facility Name
Gastro Florida
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Individual Site Status
Completed
Facility Name
One Health Research Clinic Atlanta, LLC
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30039
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
John Hopkins University
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Individual Site Status
Terminated
Facility Name
Michigan Medical
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Terminated
Facility Name
Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Individual Site Status
Withdrawn
Facility Name
NY Scientific
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Terminated
Facility Name
DiGiovanna Institute for Medical Education & Research
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Individual Site Status
Terminated
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Terminated
Facility Name
Charlotte Gastroenterology & Hepatology P.L.L.C
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Withdrawn
Facility Name
DDSI
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Withdrawn
Facility Name
Central Sooner Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Individual Site Status
Terminated
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Terminated
Facility Name
Omni Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Individual Site Status
Terminated
Facility Name
UTMB Health
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Terminated
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Terminated
Facility Name
McGuire Research Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Terminated
Facility Name
IACT Health
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Individual Site Status
Withdrawn
Facility Name
Advocate Aurora Health - Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Terminated
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qizhi Wang
First Name & Middle Initial & Last Name & Degree
Qizhi Wang
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xie
First Name & Middle Initial & Last Name & Degree
Li Xie
Facility Name
Beijing Military Area General Hospital/Seventh Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianqiu Sheng
First Name & Middle Initial & Last Name & Degree
Jianqiu Sheng
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Terminated
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigang Ding
First Name & Middle Initial & Last Name & Degree
Shigang Ding
Facility Name
Tsinghua University Changgung Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Jiang
First Name & Middle Initial & Last Name & Degree
Bo Jiang
Facility Name
Army Medical Center of PLA
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongfeng Chen
First Name & Middle Initial & Last Name & Degree
Dongfeng Chen
Facility Name
Chongqing People's Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Guo
First Name & Middle Initial & Last Name & Degree
Hong Guo
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bingqiang Zhang
First Name & Middle Initial & Last Name & Degree
Bingqiang Zhang
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengdang Wang
First Name & Middle Initial & Last Name & Degree
Chengdang Wang
Facility Name
The First Affiliated Hospitial of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwei Zheng
First Name & Middle Initial & Last Name & Degree
Jianwei Zheng
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjia Zhou
First Name & Middle Initial & Last Name & Degree
Yongjian Zhou
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baili Chen
First Name & Middle Initial & Last Name & Degree
Baili Chen
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Gao
First Name & Middle Initial & Last Name & Degree
Xiang Gao
Facility Name
Third Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingsong Li
First Name & Middle Initial & Last Name & Degree
Mingsong Li
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Zou
First Name & Middle Initial & Last Name & Degree
Bing Zou
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Lv
First Name & Middle Initial & Last Name & Degree
Xiaoping Lv
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolan Zhang
First Name & Middle Initial & Last Name & Degree
Xiaolan Zhang
Facility Name
The First Affiliated Hospital of Henan University of Science and Technoloy
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjian Zhang
First Name & Middle Initial & Last Name & Degree
Yingjian Zhang
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuling Li
First Name & Middle Initial & Last Name & Degree
Xiuling Li
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bingrong Liu
First Name & Middle Initial & Last Name & Degree
Bingrong Liu
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Hena
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baisui Feng
First Name & Middle Initial & Last Name & Degree
Feng Feng
Facility Name
Jingzhou First People's Hospital
City
Jingzhou
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Zhang
First Name & Middle Initial & Last Name & Degree
Qing Zhang
Facility Name
Affiliated Taihe Hospital of Hubei University of Medicine
City
Shiyan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengbao Li
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping An
First Name & Middle Initial & Last Name & Degree
Ping An
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuehong Wang
First Name & Middle Initial & Last Name & Degree
Xuehong Wang
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei Zhang
First Name & Middle Initial & Last Name & Degree
Xiaomei Zhang
Facility Name
Zhuzhou Central Hospital
City
Zhuzhou
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbing Zhou
First Name & Middle Initial & Last Name & Degree
Hongbing Zhou
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Zhang
First Name & Middle Initial & Last Name & Degree
Ling Zhang
Facility Name
Huai'an First People's Hospital
City
Huai'an
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijie Dai
First Name & Middle Initial & Last Name & Degree
Weijie Dai
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongjie Zhang
First Name & Middle Initial & Last Name & Degree
Hongjie Zhang
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang
Facility Name
Nanjing General Hospital of Nanjing Military Command
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangyu Wang
First Name & Middle Initial & Last Name & Degree
Fangyu Wang
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Chen
First Name & Middle Initial & Last Name & Degree
Hong Chen
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weichang Chen
First Name & Middle Initial & Last Name & Degree
Weichang Chen
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Zhu
First Name & Middle Initial & Last Name & Degree
Zhen Zhu
Facility Name
Shengjing Hospital Of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changqing Zheng
First Name & Middle Initial & Last Name & Degree
Changqing Zheng
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Terminated
Facility Name
Binzhou Medical University Hospital
City
Binzhou
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengxia Liu
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yan
First Name & Middle Initial & Last Name & Degree
Peng Yan
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Zhong
First Name & Middle Initial & Last Name & Degree
Liang Zhong
Facility Name
Longhua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Terminated
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Terminated
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Zhong
First Name & Middle Initial & Last Name & Degree
Jie Zhong
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiqi Du
First Name & Middle Initial & Last Name & Degree
Yiqi Du
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Terminated
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Terminated
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Terminated
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xizhong Shen
First Name & Middle Initial & Last Name & Degree
Xizhong Shen
Facility Name
Shanxi Provincial People's Hospital
City
Shanxi
State/Province
Shanxi
Country
China
Individual Site Status
Terminated
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijuan Huo
First Name & Middle Initial & Last Name & Degree
Lijuan Huo
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhang
First Name & Middle Initial & Last Name & Degree
Yan Zhang
Facility Name
Tianjin medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bangmao Wang
First Name & Middle Initial & Last Name & Degree
Bangmao Wang
Facility Name
Tianjin Union Medical Center
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yandi Liu
First Name & Middle Initial & Last Name & Degree
Yandi Liu
Facility Name
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihong Fan
First Name & Middle Initial & Last Name & Degree
Yihong Fan
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Chen
First Name & Middle Initial & Last Name & Degree
Yan Chen
Facility Name
Jinhua Municipal Central Hospical
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Ding
First Name & Middle Initial & Last Name & Degree
Jin Ding
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyun Ding
First Name & Middle Initial & Last Name & Degree
Xiaoyun Ding
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangrong Chen
First Name & Middle Initial & Last Name & Degree
Xiangrong Chen
Facility Name
Curatio, Jsc
City
Tbilisi
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
City
Tbilisi
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
LTD Central University Clinic After Academic N. Kipshidze
City
Tbilisi
Country
Georgia
Individual Site Status
Completed
Facility Name
LTD The First Medical Center
City
Tbilisi
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
City
Bydgoszcz
Country
Poland
Individual Site Status
Withdrawn
Facility Name
MZ BADANIA Slowik Zymla General Partnership
City
Knurow
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
"Landa" Specialist Doctor's Offices
City
Krakow
Country
Poland
Individual Site Status
Withdrawn
Facility Name
PLEJADY Medical Centre
City
Krakow
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
AMED Medical Centre Branch in Lodz
City
Lodz
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Oswiecim Clinical Trial Centre
City
Oswiecim
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Private Healthcare Institution Specialist Clinics Termedica
City
Poznan
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Dariusz Kleczkowski Specialist Medical Practice
City
Sopot
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Torun Gastrology Centre "Gastromed"
City
Torun
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
MDM Healthcare Centre
City
Warsaw
Country
Poland
Individual Site Status
Withdrawn
Facility Name
WIP Warsaw IBD Point
City
Warsaw
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Medical Centre Oporow
City
Wroclaw
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
ETG Zamosc
City
Zamosc
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
City
Cherkasy
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"
City
Chernivtsi
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
City
Ivano-Frankivsk
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Public Non-Profit Institution: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council
City
Kharkiv
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Public Non-Profit Enterprise "Khmelnytskyi Regional Hospital" under Khmelnytskyi Regional Council
City
Khmelnytskyi
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Clinical Hospital "Feofaniia"
City
Kyiv
Country
Ukraine
Individual Site Status
Completed
Facility Name
Medical Center "Consylium Medical"
City
Kyiv
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Medical Center OK!Clinic+ of the Company with Limited Liability International Institute of Clinical Research
City
Kyiv
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
City
Lutsk
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
City
Lviv
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Public Non-Profit Enterprise under Sumy Regional Council "Sumy Regional Clinical Hospital"
City
Sumy
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Communal Non-Commercial Enterprise: Vinnytsia City Clinical Hospital #1
City
Vinnytsia
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Public Non-Profit Enterprise "City Hospital #6" under Zaporizhia City Council
City
Zaporizhia
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
"Medibor Plus" Llc
City
Zhytomyr
Country
Ukraine
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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