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VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Sponsor: Oppilan Pharma Ltd
Summary
This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily. The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
213
Start Date
2021-11-30
Completion Date
2026-08-31
Last Updated
2024-11-13
Healthy Volunteers
No
Conditions
Interventions
VTX002
Dose A tablet administered orally once daily
VTX002
Dose B Tablet administered orally once daily
Placebo
Placebo Tablet for VTX002 administered orally once daily
Locations (77)
Local Site # 840030
Garden Grove, California, United States
Local Site # 840026
Lancaster, California, United States
Local Site # 840040
San Diego, California, United States
Local Site # 840001
Ventura, California, United States
Local Site # 840049
Kissimmee, Florida, United States
Local Site # 840006
Miami, Florida, United States
Local Site # 840018
Atlanta, Georgia, United States
Local Site # 840046
New Albany, Indiana, United States
Local Site # 840042
Shreveport, Louisiana, United States
Local Site # 840044
Ypsilanti, Michigan, United States
Local Site # 840043
Dayton, Ohio, United States
Local Site # 840010
Oklahoma City, Oklahoma, United States
Local Site # 840045
Myrtle Beach, South Carolina, United States
Local Site # 840013
Garland, Texas, United States
Local Site # 8400039
Lubbock, Texas, United States
Local Site # 840033
McAllen, Texas, United States
Local Site # 840007
San Marcos, Texas, United States
Local Site # 840016
Southlake, Texas, United States
Local Site # 840028
Tyler, Texas, United States
Local Site # 100002
Rousse, Bulgaria
Local Site # 100005
Rousse, Bulgaria
Local Site # 203002
Hradec Králové, Czechia
Local Site # 203001
Slaný, Czechia
Local Site # 203004
Ústí nad Labem, Czechia
Local Site # 250004
Caen, France
Local Site # 250001
Nantes, France
Local Site # 250003
Vandœuvre-lès-Nancy, France
Local Site # 268001
Tbilisi, Georgia
Local Site # 268002
Tbilisi, Georgia
Local Site # 268003
Tbilisi, Georgia
Local Site # 268004
Tbilisi, Georgia
Local Site # 268005
Tbilisi, Georgia
Local Site # 268006
Tbilisi, Georgia
Local Site # 276005
Berlin, Germany
Local Site # 276008
Brandenburg, Germany
Local Site # 276007
Duisburg, Germany
Local Site # 276009
Halle, Germany
Local Site # 276003
Nordhausen, Germany
Local Site # 348004
Békéscsaba, Hungary
Local Site # 348001
Budapest, Hungary
Local Site # 348003
Budapest, Hungary
Local Site # 348002
Székesfehérvár, Hungary
Local Site # 356001
Ahmedabad, India
Local Site # 356003
Jaipur, India
Local Site # 356005
Sūrat, India
Local Site # 380009
Milan, Italy
Local Site # 380001
Negrar, Italy
Local Site # 380004
Pavia, Italy
Local Site # 380008
Rome, Italy
Local Site # 380002
San Giovanni Rotondo, Italy
Local Site # 440002
Panevezys, Lithuania
Local Site # 440001
Vilnius, Lithuania
Local Site # 616010
Bydgoszcz, Poland
Local Site # 616012
Jelenia Góra, Poland
Local Site # 616001
Lodz, Poland
Local Site # 616017
Lodz, Poland
Local Site # 616015
Lublin, Poland
Local Site # 616004
Oświęcim, Poland
Local Site # 616011
Piotrkow Trybunalski, Poland
Local Site # 616008
Poznan, Poland
Local Site # 616014
Rzeszów, Poland
Local Site # 616007
Sosnowiec, Poland
Local Site # 616003
Warsaw, Poland
Local Site # 616006
Warsaw, Poland
Local Site # 616002
Wroclaw, Poland
Local Site # 616009
Wroclaw, Poland
Local Site # 616013
Wroclaw, Poland
Local Site # 688002
Belgrade, Serbia
Local Site # 688003
Belgrade, Serbia
Local Site # 688004
Belgrade, Serbia
Local Site # 688001
Zrenjanin, Serbia
Local Site # 703001
Košice, Slovakia
Local Site # 703003
Prešov, Slovakia
Local Site # 703002
Šahy, Slovakia
Local Site # 410003
Daegu, South Korea
Local Site # 410002
Seoul, South Korea
Local Site # 410004
Wŏnju, South Korea