Double-blind, placebo-controlled, study to evaluate GB004 in adults with mild-to-moderate active UC
- GB004 (formerly AKB-4924) is a HIF-1α stabilizer as an oral therapeutic, gut-targeted treatment for UC with higher intestinal than systemic exposure.
- Randomized 1:1:1 to receive GB004 - 480mg BID / 480 mg QD / Placebo
- 12 weeks double-blind treatment followed by 24 weeks of open label.
- Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments: a. prednisone ≤ 20 mg/day or equivalent or
b. beclomethasone ≤ 5 mg/day or
c. budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day