Colitis, Ulcerative Clinical Trial
Official title:
A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting
anti-inflammatory compound, aimed at obtaining initial information on the tolerability,
safety, pharmacokinetics (including concentrations in colon mucosa) and anti-inflammatory
activity of GSK1399686 upon oral dosing in patients with active ulcerative colitis.
The study is designed as a randomized, double-blind, double-dummy, placebo-controlled,
sequential dose escalating trial, with an active control (ASACOL) group as internal control.
Up to three cohorts (Cohorts 1-3), each consisting of approximately 20 patients with
mild-moderately active ulcerative colitis not limited to the rectum, will be included, one
for each dose level of GSK1399686 to be tested. Within a cohort, patients will be randomized
in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing
with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.
An interim analysis of fecal markers and disease activity data will be performed by the end
of Cohort 3. Based upon results, the study may be stopped or continued by recruiting either
Cohort 4 (if data on an additional dose level would be warranted to establish or clarify a
dose-response relationship) or, in the case of a robust efficacy signal at any dose level
previously studied, Cohort 5 (to expand the sample size for given dose level in order to
evaluate the efficacy of GSK1399686). The number of patients and randomization allocation
ratio may be altered in Cohort 5 and it may not include an active control arm. If Cohort 4 is
initiated upon interim analysis, then a second interim analysis may be performed at the end
of Cohort 4, to assess whether progression into Cohort 5 (as defined above) would be
justifiable.
n/a
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