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

  • STATUS
    Recruiting
  • End date
    Mar 19, 2021
  • participants needed
    144
  • sponsor
    Reistone Biopharma Company Limited
Updated on 19 November 2020
remission
crohn's disease

Summary

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 Early withdrawn subjects during the first treatment phase cannot enter the extension phase.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.

Details
Treatment placebos, SHR0302
Clinical Study IdentifierNCT03677648
SponsorReistone Biopharma Company Limited
Last Modified on19 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Crohn's Disease (Pediatric) or Inflammatory bowel disease or Crohn's Disease?
Do you have any of these conditions: crohns disease or Inflammatory bowel disease or Crohn's Disease (Pediatric) or Crohn's Disease?
Do you have any of these conditions: Crohn's Disease or Crohn's Disease (Pediatric) or crohns disease or Inflammatory bowel disease?
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 nave subjects diagnosed with Crohn's disease, (without previous exposure to treatment)
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