A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis

Phase 2 Completed 23 enrolled University of Birmingham Biotie Therapies Inc. · collab National Institute for Health Research, United Kingdom · collab University Hospital Birmingham · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a phase II study to determine the safety and preliminary efficacy of a human monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its use in the treatment of patients with primary sclerosing cholangitis (PSC).

Timeline

Start: 2015-09-08
Primary completion: 2018-10-23
Completion: 2018-10-23

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Pre-results. PMID 28674140 ↗

Publications

Arndtz K, Corrigan M, Rowe A, Kirkham A, Barton D, Fox RP, Llewellyn L, Athwal A, Wilkhu M, Chen YY, Weston C, Desai A, Adams DH, Hirschfield GM; BUTEO trial team. Investigating the safety and activity of the use of BTT1023 (Timolumab), in the treatment of patients with primary sclerosing cholangitis (BUTEO): A single-arm, two-stage, open-label, multi-centre, phase II clinical trial protocol. BMJ Open. 2017 Jul 3;7(6):e015081. doi: 10.1136/bmjopen-2016-015081.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Timolumab	Monoclonal antibody	8 mg/kg	Intravenous