RhuDex vs placebo in PBC
Research type
Research Study
Full title
Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis
IRAS ID
289044
Contact name
Michael Stieß
Contact email
Sponsor organisation
Dr. Falk Pharma GmbH
Eudract number
2020-001961-34
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
Researchers want to find out if the drug Rhudex can improve the disease Primary Biliary Cholangitis (PBC).
Rhudex is an investigational (experimental) drug that is being tested and is currently not approved by any
regulatory agency for sale. RhuDex is a novel, orally bioavailable, low molecular weight modulator of T-lymphocyte co-stimulation.This double-blind, randomised, multi-centre, placebo-controlled, comparative phase II trial will compare oral treatment with 50, 100 or 200 mg/day RhuDex granules vs placebo granules for the treatment of PBC.
As all patients will continue standard of care treatment with UDCA, a placebo arm will be included as control due to regulatory recommendations to evaluate dose-related benefits and adverse effects in randomised, double-blind, placebo controlled studies.
The study treatment duration will last 12 weeks ad each patient will have 7 study visits.
The study has three main purposes:
• To evaluate the efficacy of 3 doses of RhuDex vs placebo for the treatment of PBC in patients with an inadequate response to UDCA.
• To identify efficacious RhuDex dose(s) for the treatment of PBC for further evaluation in phase III,
• To study safety and tolerability of RhuDex.The study plans to enrol approximately 136 patients with PBC who are between the age of 18 and 74 years at up to
60 centres in Europe.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0243
Date of REC Opinion
7 Dec 2020
REC opinion
Further Information Favourable Opinion