A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis
Status:
Withdrawn
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
GSK1605786 is an oral antagonist specific for the chemokine receptor CCR9 in development for
treatment of small bowel and colonic Crohn's disease (CD). The purpose of this Phase II proof
of concept study is to investigate the efficacy and safety of GSK1605786 (500 mg twice daily)
administered orally for 16 weeks for the treatment of patients with active ulcerative colitis
(UC). A key secondary objective is to understand the mechanism by which GSK1605786 is acting
and to this end samples will be collected to confirm the degree of inhibition of CCR9 on T
lymphocytes in the blood of patients, and to explore the relationship between concentration
of drug and changes in lymphocyte and antigen presenting cell populations in the peripheral
circulation and in the colon. Patients recruited at specified investigational sites will be
invited to participate in an optional sub-study to explore the effects of GSK1605786 on
trafficking of technetium labelled T cells using Single Photon Emission Computerized
Tomography (SPECT). Specifically, the technique will be used to follow trafficking to large
intestine and thymus and findings linked to pharmacokinetics of GSK1605786, receptor
occupancy and clinical efficacy outcomes