TOP1288-TV-02 Rectal Solution Ulcerative Colitis
Research type
Research Study
Full title
A Phase 2a, Randomised, Double-Blind, Placebo- Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity
IRAS ID
206201
Contact name
Peter Irving
Contact email
Sponsor organisation
Topivert
Eudract number
2016-000390-20
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
This is a phase 2A, proof of concept, randomised, double blind study to evaluate the feasibility of TOP1288 200 mg Rectal Solution as a treatment for moderate Ulcerative Colitis (UC). The 200 mg daily dose was chosen for this study based on the results of the Phase 1 first-in-human study.
The study will include approximately 40 sites in Europe. Randomisation to study treatment will be 2:1, with approximately 40 subjects randomised to TOP1288 and approximately 20 subjects randomised to placebo.
The study will consist of up to a 4-week Screening period, followed by a 4-week double-blind treatment period, followed by a 1-week safety follow-up period, for a maximum study duration of ~65 days per subject.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/0838
Date of REC Opinion
10 Jun 2016
REC opinion
Further Information Favourable Opinion