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 at ≥18 and ≤ 75 years of age at randomization.
- - Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization.
- - Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450.
- - Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
- - Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
- - Treatment naïve subjects diagnosed with Crohn's disease, (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.
|Michael WeissAwad AmirCapozza ThomasMahesh AllamDavid Stokesberry|
|Principal Investigator Affiliation||West Central Gastro FloridaWest Central Gastro FloridaNECCR Primacare Research, LLCWellness Clinical Research, LLLC-Central FloridaDigestive Disease Specialists, Inc|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||China, Poland, 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 24.
Experimental: SHR0302 dose B
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 24.
Experimental: SHR0302 dose C
Participants randomized in this arm will receive dose C of SHR0302 until end of study at week 24.
Placebo Comparator: Placebo
Participants randomized in this arm will receive placebo until week 12, 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 24.
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
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.