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

September 1, 2023 updated by: Reistone Biopharma Company Limited

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

368

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Qizhi Wang
        • Principal Investigator:
          • Qizhi Wang
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Li Xie
        • Contact:
          • Li Xie
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Shigang Ding
        • Contact:
          • Shigang Ding
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Military Area General Hospital/Seventh Medical Center of PLA General Hospital
        • Contact:
          • Jianqiu Sheng
        • Principal Investigator:
          • Jianqiu Sheng
      • Beijing, Beijing, China
        • Terminated
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Not yet recruiting
        • Tsinghua University Changgung Hospital
        • Principal Investigator:
          • Bo Jiang
        • Contact:
          • Bo Jiang
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Army Medical Center of PLA
        • Principal Investigator:
          • Dongfeng Chen
        • Contact:
          • Dongfeng Chen
      • Chongqing, Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Bingqiang Zhang
        • Principal Investigator:
          • Bingqiang Zhang
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing People's Hospital
        • Principal Investigator:
          • Hong Guo
        • Contact:
          • Hong Guo
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The First Affiliated Hospital Of Fujian Medical University
        • Principal Investigator:
          • Chengdang Wang
        • Contact:
          • Chengdang Wang
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospitial of Xiamen University
        • Contact:
          • Jianwei Zheng
        • Principal Investigator:
          • Jianwei Zheng
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Principal Investigator:
          • Xiang Gao
        • Contact:
          • Xiang Gao
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Baili Chen
        • Contact:
          • Baili Chen
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
          • Yongjia Zhou
        • Principal Investigator:
          • Yongjian Zhou
      • Guangzhou, Guangdong, China
        • Recruiting
        • Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Mingsong Li
        • Principal Investigator:
          • Mingsong Li
      • Shenzhen, Guangdong, China
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
          • Bing Zou
        • Principal Investigator:
          • Bing Zou
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Xiaoping Lv
        • Principal Investigator:
          • Xiaoping Lv
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
          • Xiaolan Zhang
        • Principal Investigator:
          • Xiaolan Zhang
    • Hena
      • Zhengzhou, Hena, China
        • Recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
          • Baisui Feng
        • Principal Investigator:
          • Feng Feng
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of henan University of Science and Technoloy
        • Contact:
          • Yingjian Zhang
        • Principal Investigator:
          • Yingjian Zhang
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Bingrong Liu
        • Principal Investigator:
          • Bingrong Liu
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Xiuling Li
        • Principal Investigator:
          • Xiuling Li
    • Hubei
      • Jingzhou, Hubei, China
        • Recruiting
        • Jingzhou First People's Hospital
        • Contact:
          • Qing Zhang
        • Principal Investigator:
          • Qing Zhang
      • Shiyan, Hubei, China
        • Recruiting
        • Affiliated Taihe Hospital of Hubei University of Medicine
        • Principal Investigator:
          • Shengbao Li
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
          • Ping An
        • Principal Investigator:
          • Ping An
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The second Xiangya Hospital of Central South University
        • Contact:
          • Xuehong Wang
        • Principal Investigator:
          • Xuehong Wang
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Xiaomei Zhang
        • Principal Investigator:
          • Xiaomei Zhang
      • Zhuzhou, Hunan, China
        • Recruiting
        • ZhuZhou Central Hospital
        • Contact:
          • Hongbing Zhou
        • Principal Investigator:
          • Hongbing Zhou
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • Baotou Central Hospital
        • Contact:
          • Ling Zhang
        • Principal Investigator:
          • Ling Zhang
    • Jiangsu
      • Huai'an, Jiangsu, China
        • Recruiting
        • Huai'an First People's Hospital
        • Contact:
          • Weijie Dai
        • Principal Investigator:
          • Weijie Dai
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
          • Hong Chen
        • Principal Investigator:
          • Hong Chen
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Hongjie Zhang
        • Principal Investigator:
          • Hongjie ZHANG
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing First Hospital
        • Contact:
          • Zhenyu Zhang
        • Principal Investigator:
          • Zhenyu Zhang
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing General Hospital of Nanjing Military Command
        • Contact:
          • Fangyu Wang
        • Principal Investigator:
          • Fangyu Wang
      • Suzhou, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Weichang Chen
        • Principal Investigator:
          • Weichang Chen
      • Yangzhou, Jiangsu, China
        • Recruiting
        • Subei People's Hospital of Jiangsu province
        • Contact:
          • Zhen Zhu
        • Principal Investigator:
          • Zhen Zhu
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital Of China Medical University
        • Principal Investigator:
          • Changqing Zheng
        • Contact:
          • Changqing Zheng
      • Shenyang, Liaoning, China
        • Terminated
        • The First Hospital of China Medical University
    • Shandong
      • Binzhou, Shandong, China
        • Recruiting
        • Binzhou Medical University Hospital
        • Principal Investigator:
          • Chengxia Liu
      • Liaocheng, Shandong, China
        • Recruiting
        • Liaocheng People's Hospital
        • Principal Investigator:
          • Peng Yan
        • Contact:
          • Peng Yan
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
        • Principal Investigator:
          • Xizhong Shen
        • Contact:
          • Xizhong Shen
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:
          • Yiqi Du
        • Principal Investigator:
          • Yiqi Du
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Principal Investigator:
          • Jie Zhong
        • Contact:
          • Jie Zhong
      • Shanghai, Shanghai, China
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
          • Liang Zhong
        • Principal Investigator:
          • Liang Zhong
      • Shanghai, Shanghai, China
        • Terminated
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, China
        • Terminated
        • Shanghai Sixth People's Hospital
      • Shanghai, Shanghai, China
        • Terminated
        • Longhua Hospital Shanghai University of Traditional Chinese Medicine
      • Shanghai, Shanghai, China
        • Terminated
        • Shanghai East Hospital
      • Shanghai, Shanghai, China
        • Terminated
        • Shanghai General Hospital
    • Shanxi
      • Shanxi, Shanxi, China
        • Terminated
        • Shanxi Provincial People's Hospital
      • Taiyuan, Shanxi, China
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Contact:
          • Lijuan Huo
        • Principal Investigator:
          • Lijuan Huo
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital Sichuan University
        • Principal Investigator:
          • Yan Zhang
        • Contact:
          • Yan Zhang
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Bangmao Wang
        • Principal Investigator:
          • Bangmao Wang
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Union Medical Center
        • Contact:
          • Yandi Liu
        • Principal Investigator:
          • Yandi Liu
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Yan Chen
        • Contact:
          • Yan Chen
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
        • Principal Investigator:
          • Yihong Fan
        • Contact:
          • Yihong Fan
      • Jinhua, Zhejiang, China
        • Recruiting
        • Jinhua Municipal Central Hospical
        • Contact:
          • Jin Ding
        • Principal Investigator:
          • Jin Ding
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo First Hospital
        • Contact:
          • Xiaoyun Ding
        • Principal Investigator:
          • Xiaoyun Ding
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Xiangrong Chen
        • Principal Investigator:
          • Xiangrong Chen
  • Georgia
      • Tbilisi, Georgia
        • Active, not recruiting
        • Curatio, Jsc
      • Tbilisi, Georgia
        • Active, not recruiting
        • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
      • Tbilisi, Georgia
        • Active, not recruiting
        • LTD The First Medical Center
      • Tbilisi, Georgia
        • Completed
        • LTD Central University Clinic After Academic N. Kipshidze
  • Poland
      • Bydgoszcz, Poland
        • Withdrawn
        • CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
      • Knurow, Poland
        • Active, not recruiting
        • MZ BADANIA Slowik Zymla General Partnership
      • Krakow, Poland
        • Withdrawn
        • "Landa" Specialist Doctor's Offices
      • Krakow, Poland
        • Active, not recruiting
        • PLEJADY Medical Centre
      • Lodz, Poland
        • Withdrawn
        • AMED Medical Centre Branch in Lodz
      • Oswiecim, Poland
        • Active, not recruiting
        • Oswiecim Clinical Trial Centre
      • Poznan, Poland
        • Withdrawn
        • Private Healthcare Institution Specialist Clinics Termedica
      • Sopot, Poland
        • Active, not recruiting
        • Dariusz Kleczkowski Specialist Medical Practice
      • Torun, Poland
        • Active, not recruiting
        • Torun Gastrology Centre "Gastromed"
      • Warsaw, Poland
        • Withdrawn
        • MDM Healthcare Centre
      • Warsaw, Poland
        • Active, not recruiting
        • WIP Warsaw IBD Point
      • Wroclaw, Poland
        • Active, not recruiting
        • Medical Centre Oporow
      • Zamosc, Poland
        • Active, not recruiting
        • ETG Zamosc
  • Ukraine
      • Cherkasy, Ukraine
        • Active, not recruiting
        • Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
      • Chernivtsi, Ukraine
        • Withdrawn
        • Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"
      • Ivano-Frankivsk, Ukraine
        • Withdrawn
        • Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
      • Kharkiv, Ukraine
        • Withdrawn
        • Public Non-Profit Institution: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council
      • Khmelnytskyi, Ukraine
        • Withdrawn
        • Public Non-Profit Enterprise "Khmelnytskyi Regional Hospital" under Khmelnytskyi Regional Council
      • Kyiv, Ukraine
        • Active, not recruiting
        • Medical Center "Consylium Medical"
      • Kyiv, Ukraine
        • Withdrawn
        • Medical Center OK!Clinic+ of the Company with Limited Liability International Institute of Clinical Research
      • Kyiv, Ukraine
        • Completed
        • Clinical Hospital "Feofaniia"
      • Lutsk, Ukraine
        • Active, not recruiting
        • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
      • Lviv, Ukraine
        • Withdrawn
        • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
      • Sumy, Ukraine
        • Withdrawn
        • Public Non-Profit Enterprise under Sumy Regional Council "Sumy Regional Clinical Hospital"
      • Vinnytsia, Ukraine
        • Withdrawn
        • Communal Non-Commercial Enterprise: Vinnytsia City Clinical Hospital #1
      • Zaporizhia, Ukraine
        • Active, not recruiting
        • Public Non-Profit Enterprise "City Hospital #6" under Zaporizhia City Council
      • Zhytomyr, Ukraine
        • Completed
        • "Medibor Plus" Llc
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Completed
        • Digestive Health Specialists
    • California
      • Lancaster, California, United States, 93534
        • Terminated
        • Om Research LLC
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Terminated
        • Yale University
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Active, not recruiting
        • IHS Health
      • Miami, Florida, United States, 33126
        • Terminated
        • Dade Research Center
      • Pinellas Park, Florida, United States, 33781
        • Completed
        • Gastro Florida
    • Georgia
      • Norcross, Georgia, United States, 30039
        • Active, not recruiting
        • One Health Research Clinic Atlanta, LLC
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Terminated
        • John Hopkins University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Terminated
        • Michigan Medical
      • Chesterfield, Michigan, United States, 48047
        • Withdrawn
        • Research Institute of Michigan
    • New York
      • Brooklyn, New York, United States, 11235
        • Terminated
        • NY Scientific
      • North Massapequa, New York, United States, 11758
        • Terminated
        • DiGiovanna Institute for Medical Education & Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Terminated
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28207
        • Withdrawn
        • Charlotte Gastroenterology & Hepatology P.L.L.C
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Withdrawn
        • DDSI
      • Oklahoma City, Oklahoma, United States, 73118
        • Terminated
        • Central Sooner Research
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Terminated
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77034
        • Terminated
        • Omni Clinical Research
      • League City, Texas, United States, 77573
        • Terminated
        • UTMB Health
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Terminated
        • University of Utah
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Terminated
        • McGuire Research Institute
      • Suffolk, Virginia, United States, 23435
        • Withdrawn
        • IACT Health
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Terminated
        • Advocate Aurora Health - Aurora St. Luke's Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Active Experimental: SHR0302 Dose#1
SHR0302 Oral tablets taken once daily (QD) for 8 weeks SHR0302 Oral tablets taken once daily (QD)
Drug: SHR0302
Oral tablets taken once daily (QD)
Placebo Comparator: Part 1 Placebo Comparator: Placebo
Placebo Oral tablets taken once daily (QD) for 8 weeks
Drug: Placebo
Oral tablets taken once daily (QD)
Experimental: Part 2 Active Experimental: SHR0302 Dose#2
SHR0302 Oral tablets taken once daily (QD) for 44 weeks
Drug: SHR0302
Oral tablets taken once daily (QD)
Placebo Comparator: Part 2 Placebo Comparator: Placebo
Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo
Drug: Placebo
Oral tablets taken once daily (QD)
Experimental: Part 3 Active Experimental: SHR0302 Dose#2
SHR0302 Oral tablets taken once daily (QD) for 26 weeks
Drug: SHR0302
Oral tablets taken once daily (QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission at week 8 (Part 1)
Time Frame: 8 weeks
The percentage of subjects in clinical remission at week 8.
8 weeks
Clinical remission at week 52 (Part 2)
Time Frame: 52 weeks
The percentage of subjects in clinical remission at week 52.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic remission at week 8 (Part 1)
Time Frame: 8 weeks
The percentage of subjects with endoscopic remission at week 8.
8 weeks
Clinical response at week 8 (Part 1)
Time Frame: 8 weeks
The percentage of subjects with clinical response at week 8.
8 weeks
Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1)
Time Frame: 8 weeks
Change from baseline in partial Mayo score at week 2, 4, and 8.
8 weeks
Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1)
Time Frame: 8 weeks
Change in total Mayo score and 9-point modified Mayo score at week 8.
8 weeks
Subjects with endoscopic remission (Part 2)
Time Frame: 52 weeks
The percentage of subjects with endoscopic remission at week 52.
52 weeks
Subjects with clinical response at week 52 (Part 2)
Time Frame: 52 weeks
The percentage of subjects with clinical response at week 52.
52 weeks
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52 (Part 2)
Time Frame: 52 weeks
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52.
52 weeks
Change in total Mayo score and 9-point modified Mayo score at week 52 (Part 2)
Time Frame: 52 weeks
Change in total Mayo score and 9-point modified Mayo score at week 52.
52 weeks
Subjects in corticosteroid-free remission at week 52 (Part 2)
Time Frame: 52 weeks
Percentage of subjects in corticosteroid-free remission at week 52.
52 weeks
Subjects who maintain clinical remission at week 52 (Part 2)
Time Frame: 52 weeks
Percentage of subjects who maintain clinical remission at week 52
52 weeks
Subjects in clinical remission per partial Mayo score at week E26 (Part 3)
Time Frame: 26 weeks (extension)
The percentage of subjects in clinical remission per partial Mayo score at week E26.
26 weeks (extension)
Subjects in corticosteroid-free remission per Partial Mayo score at week E26 (Part 3)
Time Frame: 26 weeks (extension)
The percentage of subjects in corticosteroid-free remission per Partial Mayo score at week E26.
26 weeks (extension)
Change from baseline in Partial Mayo score at week E2, E12, and E26 (Part 3)
Time Frame: 26 weeks (extension)
Change from baseline in Partial Mayo score at week E2, E12, and E26.
26 weeks (extension)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reistone Biopharma Company Limited

Investigators

  • Study Director: Xiang Chen, 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 Major Dates

Study Start (Actual)

November 5, 2021

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSJ10135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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