Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 80 Years|
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Oppilan Pharma Ltd|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Czechia, Georgia, Germany, Hungary, Italy, Lithuania, Poland, Ukraine, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.