Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 75 Years|
- - Male and Female subject age ≥ 18 and ≤75 years of age at randomization.
- - Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline should not exceed 10 days and allow central over read turn over before randomization).
- - Subject should have at least three-month history of Ulcerative Colitis diagnosis at randomization.
- - Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
- - Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
- - Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Reistone Biopharma Company Limited|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||China, Poland, Puerto Rico, Ukraine, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Comparator: SHR0302 dose A
Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 16.
Active Comparator: SHR0302 dose B
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 16.
Active Comparator: SHR0302 dose C
Participants randomized in this arm will receive dose D of SHR0302 until end of study at week 16.
Placebo Comparator: palcebo
Participants randomized in this arm will receive placebo until week 8, and then will be re-randomized into one of the 3 active arms (dose A, dose B, and dose C of SHR0302) in a 1:1:1 allocation ratio until the end of study at week 16.
Drug: - SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Drug: - Placebos
Placebo Oral Tablet
Contact a Trial Team
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.