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 180 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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 80 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05156125 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Oppilan Pharma Ltd |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Chohee Yun, MD |
Principal Investigator Affiliation | Ventyx Biosciences, Inc |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Czechia, Georgia, Germany, Hungary, Italy, Lithuania, Poland, Ukraine, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Colitis, Ulcerative |
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of VTX002 in subjects with moderately to severely active UC following daily oral administration of VTX002 as a tablet. Approximately 180 eligible subjects will be randomized in a 1:1:1 ratio to receive VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily (approximately 60 subjects per treatment group). The study consists of a 28-day Screening Period, a 13-week double-blind Induction Treatment Period (including 7 days of titration followed by 12 weeks of treatment at the assigned dose), 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. Objectives Primary Objective. • Assess the efficacy of VTX002 when administered for 13 weeks on clinical remission. Secondary Objectives.
Experimental: VTX002 Dose A
VTX002 Dose A tablet administered orally once daily
Experimental: VTX002 Dose B
VTX002 Dose B tablet administered orally once daily
Placebo Comparator: Placebo
Placebo tablet administered orally once daily
Drug: - VTX002
Dose A tablet administered orally once daily
Drug: - VTX002
Dose B Tablet administered orally once daily
Drug: - Placebo
Placebo Tablet for VTX002 administered orally once daily
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Local Site # 840030
Garden Grove, California, 92845
Status
Recruiting
Address
Local Site # 840026
Lancaster, California, 93534
Status
Recruiting
Address
Local Site # 840025
Los Angeles, California, 90035
Status
Recruiting
Address
Local Site # 840001
Ventura, California, 93003
Status
Withdrawn
Address
Local Site # 840008
Homestead, Florida, 33030
Status
Recruiting
Address
Local Site # 840049
Kissimmee, Florida, 34744
Status
Recruiting
Address
Local Site # 840006
Miami, Florida, 33165
Status
Recruiting
Address
Local Site # 840037
Orlando, Florida, 32806
Status
Recruiting
Address
Local Site # 840018
Atlanta, Georgia, 30342
Status
Recruiting
Address
Local Site # 840017
Marietta, Georgia, 30060
Status
Recruiting
Address
Local Site # 840015
Glenview, Illinois, 60026
Status
Recruiting
Address
Local Site # 840009
Gurnee, Illinois, 60031
Status
Recruiting
Address
Local Site # 840046
New Albany, Indiana, 47150
Status
Withdrawn
Address
Local Site # 840021
Baton Rouge, Louisiana, 70809
Status
Withdrawn
Address
Local Site # 840003
Crowley, Louisiana, 70526
Status
Recruiting
Address
Local Site # 840023
Lafayette, Louisiana, 70503
Status
Recruiting
Address
Local Site # 840042
Shreveport, Louisiana, 71105
Status
Recruiting
Address
Local Site # 840041
Chevy Chase, Maryland, 20815
Status
Recruiting
Address
Local Site # 840051
Rockville, Maryland, 20850
Status
Recruiting
Address
Local Site # 840027
Chelmsford, Massachusetts, 01824
Status
Recruiting
Address
Local Site # 840038
Liberty, Missouri, 64068
Status
Recruiting
Address
Local Site # 840020
Freehold, New Jersey, 07728
Status
Recruiting
Address
Local Site # 840047
Winston-Salem, North Carolina, 27103
Status
Withdrawn
Address
Local Site # 840012
Beavercreek, Ohio, 45431
Status
Recruiting
Address
Local Site # 840048
Columbus, Ohio, 43202
Status
Recruiting
Address
Local Site # 840043
Dayton, Ohio, 45415
Status
Recruiting
Address
Local Site # 840022
Toledo, Ohio, 43614
Status
Recruiting
Address
Local Site # 840010
Oklahoma City, Oklahoma, 73101
Status
Recruiting
Address
Local Site # 840045
Myrtle Beach, South Carolina, 29572
Status
Recruiting
Address
Local Site # 840011
Nashville, Tennessee, 37204
Status
Withdrawn
Address
Local site # 840004
Austin, Texas, 78742
Status
Recruiting
Address
Local Site # 840013
Garland, Texas, 75044
Status
Recruiting
Address
Local Site # 840031
Katy, Texas, 77494
Status
Recruiting
Address
Local Site # 840039
Lubbock, Texas, 79424
Status
Recruiting
Address
Local Site # 840033
McAllen, Texas, 78503
Status
Recruiting
Address
Local Site # 840007
San Marcos, Texas, 78666
Status
Recruiting
Address
Local Site # 840016
Southlake, Texas, 76092
Status
Recruiting
Address
Local Site # 840028
Tyler, Texas, 75701
Status
Recruiting
Address
Local Site # 840024
Charlottesville, Virginia, 22908
Status
Recruiting
Address
Local Site # 203003
Brno, ,
Status
Recruiting
Address
Local Site # 203002
Hradec Králové, ,
Status
Recruiting
Address
Local Site # 203005
Ostrava, ,
Status
Recruiting
Address
Local Site # 203001
Slaný, ,
Status
Recruiting
Address
Local Site # 203004
Ústí Nad Labem, ,
Status
Recruiting
Address
Local Site # 268001
Tbilisi, ,
Status
Recruiting
Address
Local Site # 268002
Tbilisi, ,
Status
Recruiting
Address
Local Site # 268003
Tbilisi, ,
Status
Recruiting
Address
Local Site # 268004
Tbilisi, ,
Status
Recruiting
Address
Local Site # 268005
Tbilisi, ,
Status
Recruiting
Address
Local Site # 268006
Tbilisi, ,
Status
Recruiting
Address
Local Site # 276001
Augsburg, ,
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Recruiting
Address
Local Site # 276005
Berlin, ,
Status
Recruiting
Address
Local Site # 276008
Brandenburg an der Havel, ,
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Recruiting
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Local Site # 276007
Duisburg, ,
Status
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Address
Local Site # 276009
Halle, ,
Status
Recruiting
Address
Local Site # 276010
Leipzig, ,
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Recruiting
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Local Site # 276003
Nordhausen, ,
Status
Recruiting
Address
Local Site # 276002
Tuebingen, ,
Status
Recruiting
Address
Local Site # 348001
Budapest, ,
Status
Recruiting
Address
Local Site # 348003
Budapest, ,
Status
Recruiting
Address
Local Site # 348004
Békéscsaba, ,
Status
Withdrawn
Address
Local Site # 348005
Kistarcsa, ,
Status
Recruiting
Address
Local Site # 348002
Székesfehérvár, ,
Status
Recruiting
Address
Local Site # 380007
Bari, ,
Status
Recruiting
Address
Local Site # 380001
Negrar, ,
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Recruiting
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Local Site # 380008
Rome, ,
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San Giovanni Rotondo, ,
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Recruiting
Address
Local Site # 440002
Panevėžys, ,
Status
Recruiting
Address
Local Site # 440001
Vilnius, ,
Status
Withdrawn
Address
Local Site # 616005
Bochnia, ,
Status
Recruiting
Address
Local Site # 616010
Bydgoszcz, ,
Status
Recruiting
Address
Local Site # 616012
Jelenia Góra, ,
Status
Recruiting
Address
Local Site # 616015
Lublin, ,
Status
Recruiting
Address
Local Site # 616004
Oświęcim, ,
Status
Recruiting
Address
Local Site # 616011
Piotrków Trybunalski, ,
Status
Recruiting
Address
Local Site # 616008
Poznań, ,
Status
Recruiting
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Local Site # 616014
Rzeszów, ,
Status
Recruiting
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Local Site # 616007
Sosnowiec, ,
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Recruiting
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Local Site # 616003
Warsaw, ,
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Recruiting
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Local Site # 616006
Warsaw, ,
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Recruiting
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Local Site # 616002
Wrocław, ,
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Recruiting
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Local Site # 616009
Wrocław, ,
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Recruiting
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Local Site # 616013
Wrocław, ,
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Local Site # 616001
Łódź, ,
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Recruiting
Address
Local Site # 616016
Łódź, ,
Status
Recruiting
Address
Local Site # 616017
Łódź, ,
Status
Suspended
Address
Local Site # 804002
Kharkiv, ,
Status
Suspended
Address
Local Site # 804005
Kyiv, ,
Status
Suspended
Address
Local Site # 804009
Poltava, ,
Status
Suspended
Address
Local Site # 804003
Sumy, ,
Status
Suspended
Address
Local Site # 804004
Vinnytsia, ,
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©COPYRIGHT 2022 CROHN'S & COLITIS FOUNDATION
The Crohn's & Colitis Foundation is a 501(c)(3) non-profit organization dedicated to finding cures for Crohn's disease and ulcerative colitis and improving the quality of life of children and adults affected by these diseases.
Crohn’s & Colitis Foundation es una organización sin fines de lucro 501(c)(3) dedicada a encontrar la cura de la enfermedad de Crohn y la colitis ulcerosa y a mejorar la calidad de vida de las personas afectadas por estas enfermedades.