A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis
A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.
Inclusion Criteria:
Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.
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:
Exclusion Criteria:
NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
Freehold, New Jersey 07728, United States
Bydgoszcz, 85-794, Poland
Jelenia Góra, 58-500, Poland
Katowice, 40-752, Poland
Sopot, 81-756, Poland
Staszów, 28-200, Poland
Torun, 87-100, Poland
Warsaw, 02-665, Poland
Wroclaw, 51-162, Poland
Krasnoyarsk, 660037, Russia
Moscow, 115516, Russia
Novosibirsk, 630089, Russia
Saint Petersburg, 191015, Russia
Saint Petersburg, 197110, Russia
Veliky Novgorod, 173008, Russia
Cherkasy, 18009, Ukraine
Chernivtsi, 58001, Ukraine
Chernivtsi, 58001, Ukraine
Ivano-Frankivsk, 76008, Ukraine
Kharkiv, 61037, Ukraine
Kharkiv, 61058, Ukraine
Kyiv, 01030, Ukraine
Kyiv, 02091, Ukraine
Kyiv, 04050, Ukraine
Kyiv, 04078, Ukraine
Lutsk, 43005, Ukraine
Lviv, 79010, Ukraine
Odesa, 65025, Ukraine
Poltava, 36011, Ukraine
Vinnytsia, 21028, Ukraine
Zaporizhia, 69005, Ukraine
Zaporizhia, 69600, Ukraine