A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) (SCOUT)
This is a randomised, double-blind, placebo-controlled study to assess the safety and
tolerability of multiple ascending doses of BT051 in subjects with moderately to severely
active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3
ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose
levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be
based on the safety and tolerability of the previous cohort. An optional fourth cohort of up
to 20 additional subjects may be randomized 3 active:1 placebo at a dose no higher than 3200
mg at the discretion of the Sponsor.
This is a randomized, placebo-controlled, multiple-ascending-dose (MAD) study enrolling
subjects with moderately to severely active UC. Subjects with prior exposure to biologic or
JAK inhibitors will be limited to 30% of the total subject population; those who have failed
2 or more biologic therapies (i.e., biologic and JAK inhibitor, 2 biologics in the same
class, or 2 biologics from different classes) will be limited to 20% of the total subject
population. Subjects will be randomized to one of 3 doses of oral BT051 (200 mg, 800 mg, or
3200 mg) or placebo, in ascending dose groups based on the safety and tolerability of the
previous cohort. Safety and tolerability will be assessed by a Safety Review Committee (SRC)
after all subjects in each cohort have completed at least 14 days of treatment, before
proceeding to the next higher dose cohort. The SRC may recommend that the next cohort proceed
with a higher dose as planned, or the SRC may recommend additional subjects be dosed at the
current, previous, or lower dose of study drug.
Each planned dose escalation cohort (Cohorts 1-3) will include 8 subjects randomized 3:1 to
receive active drug or placebo. Starting with the lowest dose, each cohort of subjects will
receive once daily oral BT051 or placebo for a period of 28 days. Follow-up visits will be
performed at 7 and 30 days after the last dose.
An optional fourth cohort of up to 20 additional subjects may be randomized 3:1
(active:placebo) at a dose no higher than 3200 mg at the discretion of the Sponsor.
BT051 200 mg,
BT051 800 mg,
BT051 3200 mg,
BT051 up to 3200 mg
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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