A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT05181137
Last Updated: 2023-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
368 participants
INTERVENTIONAL
2021-11-05
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1 Active Experimental: SHR0302 Dose#1
SHR0302 Oral tablets taken once daily (QD) for 8 weeks SHR0302 Oral tablets taken once daily (QD)
SHR0302
Oral tablets taken once daily (QD)
Part 1 Placebo Comparator: Placebo
Placebo Oral tablets taken once daily (QD) for 8 weeks
Placebo
Oral tablets taken once daily (QD)
Part 2 Active Experimental: SHR0302 Dose#2
SHR0302 Oral tablets taken once daily (QD) for 44 weeks
SHR0302
Oral tablets taken once daily (QD)
Part 2 Placebo Comparator: Placebo
Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo
Placebo
Oral tablets taken once daily (QD)
Part 3 Active Experimental: SHR0302 Dose#2
SHR0302 Oral tablets taken once daily (QD) for 26 weeks
SHR0302
Oral tablets taken once daily (QD)
Interventions
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SHR0302
Oral tablets taken once daily (QD)
Placebo
Oral tablets taken once daily (QD)
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Reistone Biopharma Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Xiang Chen
Role: STUDY_DIRECTOR
Reistone Pharma
Locations
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Digestive Health Specialists
Dothan, Alabama, United States
Om Research LLC
Lancaster, California, United States
Yale University
New Haven, Connecticut, United States
IHS Health
Kissimmee, Florida, United States
Dade Research Center
Miami, Florida, United States
Gastro Florida
Pinellas Park, Florida, United States
One Health Research Clinic Atlanta, LLC
Norcross, Georgia, United States
John Hopkins University
Columbia, Maryland, United States
Michigan Medical
Ann Arbor, Michigan, United States
Research Institute of Michigan
Chesterfield, Michigan, United States
NY Scientific
Brooklyn, New York, United States
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology & Hepatology P.L.L.C
Charlotte, North Carolina, United States
DDSI
Oklahoma City, Oklahoma, United States
Central Sooner Research
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Omni Clinical Research
Houston, Texas, United States
UTMB Health
League City, Texas, United States
University of Utah
Salt Lake City, Utah, United States
McGuire Research Institute
Richmond, Virginia, United States
IACT Health
Suffolk, Virginia, United States
Advocate Aurora Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Military Area General Hospital/Seventh Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Tsinghua University Changgung Hospital
Beijing, Beijing Municipality, China
Army Medical Center of PLA
Chongqing, Chongqing Municipality, China
Chongqing People's Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospitial of Xiamen University
Xiamen, Fujian, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science and Technoloy
Luoyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Hena, China
Jingzhou First People's Hospital
Jingzhou, Hubei, China
Affiliated Taihe Hospital of Hubei University of Medicine
Shiyan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Provincial People's Hospital
Shanxi, Shanxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Tianjin medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jinhua Municipal Central Hospical
Jinhua, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Curatio, Jsc
Tbilisi, , Georgia
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, , Georgia
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, , Georgia
LTD The First Medical Center
Tbilisi, , Georgia
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, , Poland
MZ BADANIA Slowik Zymla General Partnership
Knurów, , Poland
"Landa" Specialist Doctor's Offices
Krakow, , Poland
PLEJADY Medical Centre
Krakow, , Poland
AMED Medical Centre Branch in Lodz
Lodz, , Poland
Oswiecim Clinical Trial Centre
Oświęcim, , Poland
Private Healthcare Institution Specialist Clinics Termedica
Poznan, , Poland
Dariusz Kleczkowski Specialist Medical Practice
Sopot, , Poland
Torun Gastrology Centre "Gastromed"
Torun, , Poland
MDM Healthcare Centre
Warsaw, , Poland
WIP Warsaw IBD Point
Warsaw, , Poland
Medical Centre Oporow
Wroclaw, , Poland
ETG Zamosc
Zamość, , Poland
Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
Cherkasy, , Ukraine
Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"
Chernivtsi, , Ukraine
Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, , Ukraine
Public Non-Profit Institution: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council
Kharkiv, , Ukraine
Public Non-Profit Enterprise "Khmelnytskyi Regional Hospital" under Khmelnytskyi Regional Council
Khmelnytskyi, , Ukraine
Clinical Hospital "Feofaniia"
Kyiv, , Ukraine
Medical Center "Consylium Medical"
Kyiv, , Ukraine
Medical Center OK!Clinic+ of the Company with Limited Liability International Institute of Clinical Research
Kyiv, , Ukraine
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
Lutsk, , Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, , Ukraine
Public Non-Profit Enterprise under Sumy Regional Council "Sumy Regional Clinical Hospital"
Sumy, , Ukraine
Communal Non-Commercial Enterprise: Vinnytsia City Clinical Hospital #1
Vinnytsia, , Ukraine
Public Non-Profit Enterprise "City Hospital #6" under Zaporizhia City Council
Zaporizhia, , Ukraine
"Medibor Plus" Llc
Zhytomyr, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Qizhi Wang
Role: primary
Li Xie
Role: primary
Jianqiu Sheng
Role: primary
Shigang Ding
Role: primary
Bo Jiang
Role: primary
Dongfeng Chen
Role: primary
Hong Guo
Role: primary
Bingqiang Zhang
Role: primary
Chengdang Wang
Role: primary
Jianwei Zheng
Role: primary
Yongjia Zhou
Role: primary
Baili Chen
Role: primary
Xiang Gao
Role: primary
Mingsong Li
Role: primary
Bing Zou
Role: primary
Xiaoping Lv
Role: primary
Xiaolan Zhang
Role: primary
Yingjian Zhang
Role: primary
Xiuling Li
Role: primary
Bingrong Liu
Role: primary
Baisui Feng
Role: primary
Qing Zhang
Role: primary
Ping An
Role: primary
Xuehong Wang
Role: primary
Xiaomei Zhang
Role: primary
Hongbing Zhou
Role: primary
Ling Zhang
Role: primary
Weijie Dai
Role: primary
Hongjie Zhang
Role: primary
Zhenyu Zhang
Role: primary
Fangyu Wang
Role: primary
Hong Chen
Role: primary
Weichang Chen
Role: primary
Zhen Zhu
Role: primary
Changqing Zheng
Role: primary
Peng Yan
Role: primary
Liang Zhong
Role: primary
Jie Zhong
Role: primary
Yiqi Du
Role: primary
Xizhong Shen
Role: primary
Lijuan Huo
Role: primary
Yan Zhang
Role: primary
Bangmao Wang
Role: primary
Yandi Liu
Role: primary
Yihong Fan
Role: primary
Yan Chen
Role: primary
Jin Ding
Role: primary
Xiaoyun Ding
Role: primary
Xiangrong Chen
Role: primary
Other Identifiers
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RSJ10135
Identifier Type: -
Identifier Source: org_study_id
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