EUCTR2018-003364-31-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 Ulcerative Colitis.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- lcerative Colitis
- Sponsor
- Reistone Biopharma Company Limited
- Enrollment
- 152
- 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.
- •Active ulcerative colitis with a 9\-point modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3\.
- •At least three\-month history of Ulcerative Colitis diagnosis at randomization.
- •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 144
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 8
Exclusion Criteria
- •Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn’s disease.
- •Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
- •Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to any of the following therapies for UC treatment: 5\-ASA, corticosteroids, immune\-suppressants, or biological treatments).
Outcomes
Primary Outcomes
Not specified
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