A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

Study Purpose

The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 26 weeks. With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with moderate to severe active CD.

Recruitment Criteria

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

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).

Trial Details

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.	NCT03677648
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 2
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.	Tia Boonyapredee
Principal Investigator Affiliation	Reistone Biopharma
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China, Poland, Ukraine, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn's Disease

Arms & Interventions

Arms

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.

Interventions

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

Placebos

Contact a Trial Team

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Clearwater, Florida

Status

Terminated

Address

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33756

Site Contact

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