A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-003364-31-PL
• Lead Sponsor: Reistone Biopharma Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-23
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 152

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified