Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis
Research type
Research Study
Full title
A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis
IRAS ID
255848
Contact name
John Seenan
Contact email
Sponsor organisation
Theravance Biopharma Ireland
Eudract number
2018-002136-24
Clinicaltrials.gov Identifier
128299, United States FDA IND Number
Duration of Study in the UK
6 years, 11 months, 26 days
Research summary
Ulcerative Colitis (UC), a type of inflammatory bowel disease (IBD), is a chronic gastrointestinal disease which has emerged as a worldwide public health challenge. UC can be a debilitating condition for patients with its most common chronic symptoms being rectal bleeding and diarrhoea. Current therapies are limited by side effects (including infection and risk of cancer), and often require regular injections/infusions or can lose effect over time. The highest reported prevalence values are in Europe (505 per 100,000) and North America (286 per 100,000 in the USA), and the incidence has risen in newly industrialised countries in Africa, Asia and South America. Consequently, there is an unmet clinical need for a treatment with better efficacy, safety profile, ease of administration and durable response for patients.
The purpose of this clinical study is to evaluate the safety and efficacy of various doses of TD-1473 compared to placebo in patients with moderately-to-severely active UC. TD-1473 is an orally administered medication designed to act against the chronic inflammation in the bowel while minimising exposure to the rest of the body.
This study is conducted in 3 parts, each utilising a double-blind, randomised, placebo-controlled, parallel-group design. The first part is a dose-finding induction phase to investigate the effect of a few different doses of TD-1473. The next is a dose-confirming phase, in which a particular dose of TD-1473, as determined from the induction study analysis will be used. Participants who reach clinical response from either of these two parts can roll over into the maintenance phase of the study.
Approximately 880 participants (male or female aged 18 or over) will be recruited at study sites globally, for a maximum duration of 68 weeks. Throughout the study, participants will be required to complete certain procedures, such as blood tests, endoscopies, imaging, electrocardiograms and questionnaires.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0164
Date of REC Opinion
4 Feb 2019
REC opinion
Further Information Favourable Opinion