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
Who is this study for? Patients with moderately to severely active ulcerative colitis
What treatments are being studied? VTX002
Status: Active_not_recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Diagnosed with UC ≥ 3 months prior to Screening.
• Active UC confirmed by endoscopy
Locations
United States
California
Local Site # 840030
Garden Grove
Local Site # 840026
Lancaster
Local Site # 840040
San Diego
Local Site # 840001
Ventura
Florida
Local Site # 840049
Kissimmee
Local Site # 840006
Miami
Georgia
Local Site # 840018
Atlanta
Indiana
Local Site # 840046
New Albany
Louisiana
Local Site # 840042
Shreveport
Michigan
Local Site # 840044
Ypsilanti
Ohio
Local Site # 840043
Dayton
Oklahoma
Local Site # 840010
Oklahoma City
South Carolina
Local Site # 840045
Myrtle Beach
Texas
Local Site # 840013
Garland
Local Site # 8400039
Lubbock
Local Site # 840033
Mcallen
Local Site # 840007
San Marcos
Local Site # 840016
Southlake
Local Site # 840028
Tyler
Other Locations
Bulgaria
Local Site # 100002
Rousse
Local Site # 100005
Rousse
France
Local Site # 250004
Caen
Local Site # 250001
Nantes
Local Site # 250003
Vandœuvre-lès-nancy
Georgia
Local Site # 268001
Tbilisi
Local Site # 268002
Tbilisi
Local Site # 268003
Tbilisi
Local Site # 268004
Tbilisi
Local Site # 268005
Tbilisi
Local Site # 268006
Tbilisi
Germany
Local Site # 276005
Berlin
Local Site # 276008
Brandenburg
Local Site # 276007
Duisburg
Local Site # 276009
Halle
Local Site # 276003
Nordhausen
Hungary
Local Site # 348004
Békéscsaba
Local Site # 348001
Budapest
Local Site # 348003
Budapest
Local Site # 348002
Székesfehérvár
India
Local Site # 356001
Ahmedabad
Local Site # 356003
Jaipur
Local Site # 356005
Sūrat
Italy
Local Site # 380009
Milan
Local Site # 380001
Negrar
Local Site # 380004
Pavia
Local Site # 380008
Rome
Local Site # 380002
San Giovanni Rotondo
Lithuania
Local Site # 440002
Panevezys
Local Site # 440001
Vilnius
Poland
Local Site # 616010
Bydgoszcz
Local Site # 616012
Jelenia Góra
Local Site # 616001
Lodz
Local Site # 616017
Lodz
Local Site # 616015
Lublin
Local Site # 616004
Oświęcim
Local Site # 616011
Piotrkow Trybunalski
Local Site # 616008
Poznan
Local Site # 616014
Rzeszów
Local Site # 616007
Sosnowiec
Local Site # 616003
Warsaw
Local Site # 616006
Warsaw
Local Site # 616002
Wroclaw
Local Site # 616009
Wroclaw
Local Site # 616013
Wroclaw
Republic of Korea
Local Site # 410003
Daegu
Local Site # 410002
Seoul
Local Site # 410004
Wŏnju
Serbia
Local Site # 688002
Belgrade
Local Site # 688003
Belgrade
Local Site # 688004
Belgrade
Local Site # 688001
Zrenjanin
Slovakia
Local Site # 703001
Košice
Local Site # 703003
Prešov
Local Site # 703002
Šahy
Time Frame
Start Date:2021-11-30
Completion Date:2026-08-31
Participants
Target number of participants:213
Treatments
Experimental: VTX002 Dose A
VTX002 Dose A tablet administered orally once daily
Experimental: VTX002 Dose B
VTX002 Dose B tablet administered orally once daily