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.

Snehal U Naik, PhD
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, 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

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.

Local Site # 840026, Lancaster, California

Status

Recruiting

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Local Site # 840026

Lancaster, California, 93534

Local Site # 840025, Los Angeles, California

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Recruiting

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Local Site # 840025

Los Angeles, California, 90035

Local Site # 840001, Ventura, California

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Recruiting

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Local Site # 840001

Ventura, California, 93003

Local Site # 840008, Homestead, Florida

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Withdrawn

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Local Site # 840008

Homestead, Florida, 33030

Local Site # 840006, Miami, Florida

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Recruiting

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Local Site # 840006

Miami, Florida, 33165

Local Site # 840017, Marietta, Georgia

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Recruiting

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Local Site # 840017

Marietta, Georgia, 30060

Local Site # 840015, Glenview, Illinois

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Recruiting

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Local Site # 840015

Glenview, Illinois, 60026

Local Site # 840009, Gurnee, Illinois

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Recruiting

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Local Site # 840009

Gurnee, Illinois, 60031

Local Site # 840021, Baton Rouge, Louisiana

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Withdrawn

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Local Site # 840021

Baton Rouge, Louisiana, 70809

Local Site # 840003, Crowley, Louisiana

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Withdrawn

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Local Site # 840003

Crowley, Louisiana, 70526

Local Site # 840023, Lafayette, Louisiana

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Recruiting

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Local Site # 840023

Lafayette, Louisiana, 70503

Local Site # 840027, Chelmsford, Massachusetts

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Recruiting

Address

Local Site # 840027

Chelmsford, Massachusetts, 01824

Local Site # 840020, Freehold, New Jersey

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Recruiting

Address

Local Site # 840020

Freehold, New Jersey, 07728

Local Site # 840012, Beavercreek, Ohio

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Withdrawn

Address

Local Site # 840012

Beavercreek, Ohio, 45431

Local Site # 840010, Oklahoma City, Oklahoma

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Recruiting

Address

Local Site # 840010

Oklahoma City, Oklahoma, 73101

Local Site # 840011, Nashville, Tennessee

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Recruiting

Address

Local Site # 840011

Nashville, Tennessee, 37204

Local site # 840004, Austin, Texas

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Withdrawn

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Local site # 840004

Austin, Texas, 78742

Local Site # 840013, Garland, Texas

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Recruiting

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Local Site # 840013

Garland, Texas, 75044

Local Site # 840031, Katy, Texas

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Recruiting

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Local Site # 840031

Katy, Texas, 77494

Local Site # 840033, McAllen, Texas

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Recruiting

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Local Site # 840033

McAllen, Texas, 78503

Local Site # 840007, San Marcos, Texas

Status

Recruiting

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Local Site # 840007

San Marcos, Texas, 78666

Local Site # 840016, Southlake, Texas

Status

Recruiting

Address

Local Site # 840016

Southlake, Texas, 76092

Local Site # 840028, Tyler, Texas

Status

Recruiting

Address

Local Site # 840028

Tyler, Texas, 75701

Local Site # 840024, Charlottesville, Virginia

Status

Recruiting

Address

Local Site # 840024

Charlottesville, Virginia, 22908

International Sites

Local Site # 203003, Brno, Czechia

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Recruiting

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Local Site # 203003

Brno, ,

Local Site # 203002, Hradec Králové, Czechia

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Recruiting

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Local Site # 203002

Hradec Králové, ,

Local Site # 203005, Ostrava, Czechia

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Recruiting

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Local Site # 203005

Ostrava, ,

Local Site # 203001, Slaný, Czechia

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Recruiting

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Local Site # 203001

Slaný, ,

Local Site # 203004, Ústí Nad Labem, Czechia

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Recruiting

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Local Site # 203004

Ústí Nad Labem, ,

Local Site # 268001, Tbilisi, Georgia

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Recruiting

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Local Site # 268001

Tbilisi, ,

Local Site # 268002, Tbilisi, Georgia

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Recruiting

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Local Site # 268002

Tbilisi, ,

Local Site # 268003, Tbilisi, Georgia

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Recruiting

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Local Site # 268003

Tbilisi, ,

Local Site # 268004, Tbilisi, Georgia

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Recruiting

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Local Site # 268004

Tbilisi, ,

Local Site # 268005, Tbilisi, Georgia

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Recruiting

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Local Site # 268005

Tbilisi, ,

Local Site # 268006, Tbilisi, Georgia

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Recruiting

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Local Site # 268006

Tbilisi, ,

Local Site # 276005, Berlin, Germany

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Recruiting

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Local Site # 276005

Berlin, ,

Local Site # 276008, Brandenburg an der Havel, Germany

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Recruiting

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Local Site # 276008

Brandenburg an der Havel, ,

Local Site # 276009, Halle, Germany

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Recruiting

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Local Site # 276009

Halle, ,

Local Site # 276003, Nordhausen, Germany

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Recruiting

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Local Site # 276003

Nordhausen, ,

Local Site # 348001, Budapest, Hungary

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Recruiting

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Local Site # 348001

Budapest, ,

Local Site # 348003, Budapest, Hungary

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Recruiting

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Local Site # 348003

Budapest, ,

Local Site # 348004, Békéscsaba, Hungary

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Recruiting

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Local Site # 348004

Békéscsaba, ,

Local Site # 348005, Kistarcsa, Hungary

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Recruiting

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Local Site # 348005

Kistarcsa, ,

Local Site # 348002, Székesfehérvár, Hungary

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Recruiting

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Local Site # 348002

Székesfehérvár, ,

Local Site # 440002, Panevėžys, Lithuania

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Recruiting

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Local Site # 440002

Panevėžys, ,

Local Site # 440001, Vilnius, Lithuania

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Recruiting

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Local Site # 440001

Vilnius, ,

Local Site # 616005, Bochnia, Poland

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Recruiting

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Local Site # 616005

Bochnia, ,

Local Site # 616010, Bydgoszcz, Poland

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Recruiting

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Local Site # 616010

Bydgoszcz, ,

Local Site # 616012, Jelenia Góra, Poland

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Recruiting

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Local Site # 616012

Jelenia Góra, ,

Local Site # 616015, Lublin, Poland

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Recruiting

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Local Site # 616015

Lublin, ,

Local Site # 616004, Oświęcim, Poland

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Recruiting

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Local Site # 616004

Oświęcim, ,

Local Site # 616011, Piotrków Trybunalski, Poland

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Recruiting

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Local Site # 616011

Piotrków Trybunalski, ,

Local Site # 616008, Poznań, Poland

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Recruiting

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Local Site # 616008

Poznań, ,

Local Site # 616014, Rzeszów, Poland

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Recruiting

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Local Site # 616014

Rzeszów, ,

Local Site # 616007, Sosnowiec, Poland

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Recruiting

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Local Site # 616007

Sosnowiec, ,

Local Site # 616003, Warsaw, Poland

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Recruiting

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Local Site # 616003

Warsaw, ,

Local Site # 616006, Warsaw, Poland

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Recruiting

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Local Site # 616006

Warsaw, ,

Local Site # 616002, Wrocław, Poland

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Recruiting

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Local Site # 616002

Wrocław, ,

Local Site # 616009, Wrocław, Poland

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Recruiting

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Local Site # 616009

Wrocław, ,

Local Site # 616013, Wrocław, Poland

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Recruiting

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Local Site # 616013

Wrocław, ,

Local Site # 616001, Łódź, Poland

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Recruiting

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Local Site # 616001

Łódź, ,

Local Site # 616017, Łódź, Poland

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Recruiting

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Local Site # 616017

Łódź, ,

Local Site # 804002, Kharkiv, Ukraine

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Suspended

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Local Site # 804002

Kharkiv, ,

Local Site # 804005, Kyiv, Ukraine

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Suspended

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Local Site # 804005

Kyiv, ,

Local Site # 804009, Poltava, Ukraine

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Suspended

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Local Site # 804009

Poltava, ,

Local Site # 804003, Sumy, Ukraine

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Suspended

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Local Site # 804003

Sumy, ,

Local Site # 804004, Vinnytsia, Ukraine

Status

Suspended

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Local Site # 804004

Vinnytsia, ,

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