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|
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.
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.
- - 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.
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, Georgia, Poland, Ukraine, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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)
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.