EUCTR2018-003303-19-PL
Active, not recruiting
Phase 1
A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Crohn’s Disease
- Sponsor
- Reistone Biopharma Company Limited
- Enrollment
- 144
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female age \= 18 and \=75 years of age at randomization.
- •Subjects with a documented at least 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\.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 137
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 7
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 any of the following therapies for CD treatment: 5\-
- •ASA, corticosteroids, immune\-suppressants, or biological treatment).
Outcomes
Primary Outcomes
Not specified
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