VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Study Purpose

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.

Recruitment Criteria

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

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosed with UC ≥ 3 months prior to Screening.

- Active UC confirmed by endoscopy.

Exclusion Criteria:

- Severe extensive colitis.

- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD.

- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Trial Details

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

Additional Details

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.

- Assess the efficacy of VTX002 when administered for 13 weeks on endoscopic changes, symptomatic response and remission, histology, and mucosal healing.

- Assess the safety of VTX002 after daily doses for 13 weeks.

- Assess the pharmacokinetics (PK) of VTX002.

Long-Term and Open-Label Extension Objectives.

- Assess the efficacy of VTX002 through the LTE and OLE Treatment Periods on endoscopic changes, symptomatic response and remission, histology, and mucosal healing.

- Assess the safety of VTX002 through the LTE and OLE Treatment Periods

Arms & Interventions

Arms

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

Interventions

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

Contact a Trial Team

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Local Site # 840030, Garden Grove, California

Status

Recruiting

Address

Local Site # 840030

Garden Grove, California, 92845

Site Contact

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