OBADIAH-2 version 0.9
Research type
Research Study
Full title
OBADIAH-2: A randomised, double-blind, placebo-controlled trial of two doses of obeticholic acid and placebo in patients with primary bile acid diarrhoea
IRAS ID
261220
Contact name
Julian Walters
Contact email
Eudract number
2019-001531-32
Clinicaltrials.gov Identifier
N/a, N/A
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Primary bile acid diarrhoea (PBAD) is the cause of symptoms in a large proportion of patients who meet criteria for chronic functional diarrhoea and/or diarrhoea-predominant irritable bowel syndrome (IBS-D). Obeticholic acid (OCA) has previously been shown in a proof-of-concept, open-label study (Obadiah-1) using 25mg once daily to be a safe and effective treatment in patients with PBAD. A longer term response to OCA 10mg once daily has been shown in case reports.
We aim to conduct a phase 2B, randomised, double-blind, placebo-controlled study to determine the response of PBAD patients to OCA, using two doses of 10mg and 25mg once daily, followed by an open-label extension when all patients will receive OCA 25mg. We will collect safety and efficacy data, together with samples for subsequent studies exploring predictors of response. The study will last about 16 weeks with an optional 12 week extension.
This is an investigator-initiated research study funded by Intercept Pharma. It will be conducted at the NIHR Imperial Clinical Research Facility at the Hammersmith Hospital in London.
REC name
London - South East Research Ethics Committee
REC reference
19/LO/1782
Date of REC Opinion
20 Dec 2019
REC opinion
Further Information Favourable Opinion