BUTEO: A clinical trial of BTT1023 in patients with PSC
Research type
Research Study
Full title
A single arm, two-stage, multi-centre, phase II clinical trial investigating the safety and activity of the use of BTT1023, a human monoclonal antibody targeting vascular adhesion protein (VAP-1), in the treatment of patients with primary sclerosing cholangitis (PSC)
IRAS ID
146127
Contact name
Gideon Hirschfield
Contact email
Eudract number
2014-002393-37
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
HE2022, CRCTU CAS ref
Duration of Study in the UK
3 years, 10 months, 30 days
Research summary
Primary sclerosing cholangitis (PSC) is an autoimmune disease in which patients develop bile duct inflammation and subsequently liver scarring. There are no present treatments for patients with PSC and most patients with symptomatic disease eventually need a liver transplant. BUTEO is a clinical trial that aims to assess whether the antibody, BTT1023, which targets a protein involved in inflammation and scarring, is safe as well as effective in the treatment of PSC. BTT1023 targets a protein called VAP-1 and this enzyme has been studied in many autoimmune diseases including PSC, where our studies show it to be important. PSC is diagnosed by MRI scans usually but blood tests can be used to follow the disease, including in particular elevations in one particular marker of bile duct inflammation, alkaline phosphatase (ALP). In this trial we wish to see whether the study drug can be given safely to patients diagnosed with PSC and whether it reduces inflammation and scarring. Blood tests and scans will be used to see if the drug is working. BTT1023 will be given to patients using intravenous infusion. With informed consent, patients who have been diagnosed with PSC and whose ALP is elevated, will be eligible to be screened to take part in the study. The trial will be conducted at 3 hospital sites in England and lasts approximately 25 weeks from the first day of screening through to the last follow up visit. The screening phase involves 2 visits over an 8 week period. The treatment phase of the trial lasts for 11 weeks and includes 7 infusions of the BTT1023 study drug. The follow up phase of the trial involves 2 follow up visits over 6 weeks. At the end of the study the goal will be to see if larger studies of BTT1023 are warranted.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/1272
Date of REC Opinion
6 Jan 2015
REC opinion
Further Information Favourable Opinion