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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 75 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05181137 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Reistone Biopharma Company Limited |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | China, Georgia, Poland, Ukraine, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ulcerative Colitis |
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.
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)
Placebo Comparator: Part 1 Placebo Comparator: Placebo
Placebo Oral tablets taken once daily (QD) for 8 weeks
Experimental: Part 2 Active Experimental: SHR0302 Dose#2
SHR0302 Oral tablets taken once daily (QD) for 44 weeks
Placebo Comparator: Part 2 Placebo Comparator: Placebo
Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo
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)
Drug: - Placebo
Oral tablets taken once daily (QD)
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Completed
Address
Digestive Health Specialists
Dothan, Alabama, 36301
Status
Terminated
Address
Om Research LLC
Lancaster, California, 93534
Status
Terminated
Address
Yale University
New Haven, Connecticut, 06510
Status
Active, not recruiting
Address
IHS Health
Kissimmee, Florida, 34741
Status
Terminated
Address
Dade Research Center
Miami, Florida, 33126
Status
Completed
Address
Gastro Florida
Pinellas Park, Florida, 33781
Status
Active, not recruiting
Address
One Health Research Clinic Atlanta, LLC
Norcross, Georgia, 30039
Status
Terminated
Address
John Hopkins University
Columbia, Maryland, 21045
Status
Terminated
Address
Michigan Medical
Ann Arbor, Michigan, 48109
Status
Withdrawn
Address
Research Institute of Michigan
Chesterfield, Michigan, 48047
Status
Terminated
Address
NY Scientific
Brooklyn, New York, 11235
Status
Terminated
Address
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, 11758
Status
Terminated
Address
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Status
Withdrawn
Address
Charlotte Gastroenterology & Hepatology P.L.L.C
Charlotte, North Carolina, 28207
Status
Withdrawn
Address
DDSI
Oklahoma City, Oklahoma, 73112
Status
Terminated
Address
Central Sooner Research
Oklahoma City, Oklahoma, 73118
Status
Terminated
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Status
Terminated
Address
Omni Clinical Research
Houston, Texas, 77034
Status
Terminated
Address
UTMB Health
League City, Texas, 77573
Status
Terminated
Address
University of Utah
Salt Lake City, Utah, 84132
Status
Terminated
Address
McGuire Research Institute
Richmond, Virginia, 23249
Status
Withdrawn
Address
IACT Health
Suffolk, Virginia, 23435
Status
Terminated
Address
Advocate Aurora Health - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Status
Recruiting
Address
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui,
Status
Recruiting
Address
Anhui Provincial Hospital
Hefei, Anhui,
Status
Recruiting
Address
Beijing Military Area General Hospital/Seventh Medical Center of PLA General Hospital
Beijing, Beijing,
Status
Terminated
Address
Peking University First Hospital
Beijing, Beijing,
Status
Recruiting
Address
Peking University Third Hospital
Beijing, Beijing,
Status
Active, not recruiting
Address
Tsinghua University Changgung Hospital
Beijing, Beijing,
Status
Not yet recruiting
Address
Army Medical Center of PLA
Chongqing, Chongqing,
Status
Active, not recruiting
Address
Chongqing People's Hospital
Chongqing, Chongqing,
Status
Recruiting
Address
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing,
Status
Recruiting
Address
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian,
Status
Not yet recruiting
Address
The First Affiliated Hospitial of Xiamen University
Xiamen, Fujian,
Status
Recruiting
Address
Guangzhou First People's Hospital
Guangzhou, Guangdong,
Status
Recruiting
Address
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong,
Status
Recruiting
Address
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong,
Status
Active, not recruiting
Address
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong,
Status
Recruiting
Address
Peking University Shenzhen Hospital
Shenzhen, Guangdong,
Status
Recruiting
Address
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi,
Status
Recruiting
Address
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei,
Status
Recruiting
Address
The First Affiliated Hospital of Henan University of Science and Technoloy
Luoyang, Henan,
Status
Recruiting
Address
Henan Provincial People's Hospital
Zhengzhou, Henan,
Status
Recruiting
Address
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan,
Status
Recruiting
Address
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Hena,
Status
Active, not recruiting
Address
Jingzhou First People's Hospital
Jingzhou, Hubei,
Status
Recruiting
Address
Affiliated Taihe Hospital of Hubei University of Medicine
Shiyan, Hubei,
Status
Not yet recruiting
Address
Renmin Hospital of Wuhan University
Wuhan, Hubei,
Status
Recruiting
Address
The Second Xiangya Hospital of Central South University
Changsha, Hunan,
Status
Recruiting
Address
Xiangya Hospital Central South University
Changsha, Hunan,
Status
Not yet recruiting
Address
Zhuzhou Central Hospital
Zhuzhou, Hunan,
Status
Recruiting
Address
Baotou Central Hospital
Baotou, Inner Mongolia,
Status
Recruiting
Address
Huai'an First People's Hospital
Huai'an, Jiangsu,
Status
Not yet recruiting
Address
Jiangsu Province Hospital
Nanjing, Jiangsu,
Status
Recruiting
Address
Nanjing First Hospital
Nanjing, Jiangsu,
Status
Recruiting
Address
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu,
Status
Recruiting
Address
Zhongda Hospital Southeast University
Nanjing, Jiangsu,
Status
Recruiting
Address
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu,
Status
Recruiting
Address
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu,
Status
Recruiting
Address
Shengjing Hospital Of China Medical University
Shenyang, Liaoning,
Status
Terminated
Address
The First Hospital of China Medical University
Shenyang, Liaoning,
Status
Recruiting
Address
Liaocheng People's Hospital
Liaocheng, Shandong,
Status
Recruiting
Address
Binzhou Medical University Hospital
Binzhou, Shandon,
Status
Recruiting
Address
Huashan Hospital, Fudan University
Shanghai, Shanghai,
Status
Recruiting
Address
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai,
Status
Terminated
Address
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai,
Status
Recruiting
Address
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai,
Status
Recruiting
Address
Shanghai Changhai Hospital
Shanghai, Shanghai,
Status
Recruiting
Address
Shanghai East Hospital
Shanghai, Shanghai,
Status
Not yet recruiting
Address
Shanghai General Hospital
Shanghai, Shanghai,
Status
Terminated
Address
Shanghai Sixth People's Hospital
Shanghai, Shanghai,
Status
Recruiting
Address
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai,
Status
Terminated
Address
Shanxi Provincial People's Hospital
Shanxi, Shanxi,
Status
Recruiting
Address
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi,
Status
Recruiting
Address
West China Hospital Sichuan University
Chengdu, Sichuan,
Status
Recruiting
Address
Tianjin medical University General Hospital
Tianjin, Tianjin,
Status
Recruiting
Address
Tianjin Union Medical Center
Tianjin, Tianjin,
Status
Recruiting
Address
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang,
Status
Recruiting
Address
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang,
Status
Not yet recruiting
Address
Jinhua Municipal Central Hospical
Jinhua, Zhejiang,
Status
Recruiting
Address
Ningbo First Hospital
Ningbo, Zhejiang,
Status
Recruiting
Address
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang,
Status
Active, not recruiting
Address
Curatio, Jsc
Tbilisi, ,
Status
Active, not recruiting
Address
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, ,
Status
Active, not recruiting
Address
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, ,
Status
Active, not recruiting
Address
LTD The First Medical Center
Tbilisi, ,
Status
Withdrawn
Address
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, ,
Status
Active, not recruiting
Address
MZ BADANIA Slowik Zymla General Partnership
Knurow, ,
Status
Withdrawn
Address
"Landa" Specialist Doctor's Offices
Krakow, ,
Status
Active, not recruiting
Address
PLEJADY Medical Centre
Krakow, ,
Status
Withdrawn
Address
AMED Medical Centre Branch in Lodz
Lodz, ,
Status
Active, not recruiting
Address
Oswiecim Clinical Trial Centre
Oswiecim, ,
Status
Withdrawn
Address
Private Healthcare Institution Specialist Clinics Termedica
Poznan, ,
Status
Active, not recruiting
Address
Dariusz Kleczkowski Specialist Medical Practice
Sopot, ,
Status
Active, not recruiting
Address
Torun Gastrology Centre "Gastromed"
Torun, ,
Status
Withdrawn
Address
MDM Healthcare Centre
Warsaw, ,
Status
Active, not recruiting
Address
WIP Warsaw IBD Point
Warsaw, ,
Status
Active, not recruiting
Address
Medical Centre Oporow
Wroclaw, ,
Status
Active, not recruiting
Address
ETG Zamosc
Zamosc, ,
Status
Active, not recruiting
Address
Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
Cherkasy, ,
Status
Withdrawn
Address
Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"
Chernivtsi, ,
Status
Withdrawn
Address
Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, ,
Status
Withdrawn
Address
Public Non-Profit Institution: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council
Kharkiv, ,
Status
Withdrawn
Address
Public Non-Profit Enterprise "Khmelnytskyi Regional Hospital" under Khmelnytskyi Regional Council
Khmelnytskyi, ,
Status
Active, not recruiting
Address
Clinical Hospital "Feofaniia"
Kyiv, ,
Status
Active, not recruiting
Address
Medical Center "Consylium Medical"
Kyiv, ,
Status
Withdrawn
Address
Medical Center OK!Clinic+ of the Company with Limited Liability International Institute of Clinical Research
Kyiv, ,
Status
Active, not recruiting
Address
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
Lutsk, ,
Status
Withdrawn
Address
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, ,
Status
Withdrawn
Address
Public Non-Profit Enterprise under Sumy Regional Council "Sumy Regional Clinical Hospital"
Sumy, ,
Status
Withdrawn
Address
Communal Non-Commercial Enterprise: Vinnytsia City Clinical Hospital #1
Vinnytsia, ,
Status
Active, not recruiting
Address
Public Non-Profit Enterprise "City Hospital #6" under Zaporizhia City Council
Zaporizhia, ,
Status
Active, not recruiting
Address
"Medibor Plus" Llc
Zhytomyr, ,
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©COPYRIGHT 2022 CROHN'S & COLITIS FOUNDATION
The Crohn's & Colitis Foundation is a 501(c)(3) non-profit organization dedicated to finding cures for Crohn's disease and ulcerative colitis and improving the quality of life of children and adults affected by these diseases.
Crohn’s & Colitis Foundation es una organización sin fines de lucro 501(c)(3) dedicada a encontrar la cura de la enfermedad de Crohn y la colitis ulcerosa y a mejorar la calidad de vida de las personas afectadas por estas enfermedades.