A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90033, United States
Los Angeles, California 90045, United States
Chicago, Illinois 60611, United States
Greenfield Park, Quebec J4V 2H1, Canada
Ottawa, Quebec K1H 8L6, Canada
Zagreb, 10000, Croatia
Larissa Thessaly, 41110, Greece
San Giovanni Rotondo FG, 71013, Italy
Chisinau, MD2005, Moldova
Maastrich, 6202 AZ, Netherlands
Sittard-Geleen, 6162 BG, Netherlands
Torun, 87-100, Poland
Wierzchosławice, 33-122, Poland
Bucharest, 050098, Romania
Cluj-Napoca, 400132, Romania
Timișoara, 300723, Romania
Irkutsk, 664005, Russia
Nizhny Novgorod, 603126, Russia
Novosibirsk, 630117, Russia
Saint Petersburg, 194044, Russia
Saint Petersburg, 194044, Russia
Saint-Peterburg, 191119, Russia
Samara, 443011, Russia
Belgrade, 11000, Serbia
Kragujevac, 34000, Serbia
Chernivtsi, 58002, Ukraine
Dnipropetrovsk, 49074, Ukraine
Ivano-Frankivsk, 76014, Ukraine
Ivano-Frankivsk, 76018, Ukraine
Kyiv, 04053, Ukraine
Lviv, 79059, Ukraine
Vinnytsia, 21005, Ukraine
Zaporizhia, 69000, Ukraine
Zaporizhia, 69065, Ukraine
Zaporizhia, 69104, Ukraine
Zaporizhzhya, 69065, Ukraine