VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease

NCT05688852 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: VTX958-202
• Study Type: interventional
• Target: 107
• Locations: 15 countries
• Sites: 105

Brief Summary

This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease.

Conditions

Crohn Disease

Keywords

VTX958; Harmony; Crohn's disease; TYK2

Outcome Measures

Primary Outcomes (1)

• Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12

  Change in Mean CDAI (Crohn's disease Activity Index). CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.

  During screening to week 12

Secondary Outcomes (6)

• The proportion of participants achieving endoscopic response at Week 12

  During screening to week 12

• Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12

  During screening to week 12

• Proportion of participants achieving clinical remission at Week 12

  During screening to week 12

• Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12

  During screening to week 12

• Proportion of participants achieving clinical response at Week 12

  During screening to week 12

Study Arms (3)

VTX958 Dose A

EXPERIMENTAL

Drug: VTX958

VTX958 Dose B

EXPERIMENTAL

Drug: VTX958

VTX958 Placebo

PLACEBO COMPARATOR

Drug: VTX958 Placebo

Interventions

VTX958 DRUG

Dose A VTX958

VTX958 Dose A

VTX958 Placebo DRUG

Placebo

VTX958 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, 18 to 75 years of age, inclusive, at the time of consent
• Capable of giving signed informed consent
• Documented diagnosis of CD ≥ 3 months prior to Day 1. The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence.
• Moderately to severely active CD

You may not qualify if:

• Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
• Presence of a stoma or ileoanal pouch
• Presence of currently known complications of CD such as symptomatic bowel stricture(s) and \>2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left and sigmoid colon, and rectum, fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization
• Known diagnosis of short gut or bowel syndrome
• Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study

Sponsors & Collaborators

• Ventyx Biosciences, Inc: lead

Study Sites (105)

Local Site # 840105

Garden Grove, California, 92845, United States

Location

Local Site # 840109

Lancaster, California, 93534, United States

Location

Local Site # 840124

Kissimmee, Florida, 34744, United States

Location

Local Site # 840104

Miami, Florida, 33165, United States

Location

Local Site # 840108

Orlando, Florida, 32806, United States

Location

Local Site # 840125

Orlando, Florida, 32825, United States

Location

Local Site # 840112

Atlanta, Georgia, 30342, United States

Location

Local Site # 840115

Glenview, Illinois, 60026, United States

Location

Local Site # 840107

Gurnee, Illinois, 60031, United States

Location

Local Site # 840119

New Albany, Indiana, 47150, United States

Location

Local Site # 840127

Louisville, Kentucky, 40218, United States

Location

Local Site # 840113

Shreveport, Louisiana, 71105, United States

Location

Local Site # 840117

Chevy Chase, Maryland, 20815, United States

Location

Local Site # 840118

Rockville, Maryland, 20850, United States

Location

Local Site # 840116

Liberty, Missouri, 64068, United States

Location

Local Site # 840121

Winston-Salem, North Carolina, 27103, United States

Location

Local Site # 840122

Columbus, Ohio, 43202, United States

Location

Local Site # 840106

Oklahoma City, Oklahoma, 73102, United States

Location

Local Site # 840123

Myrtle Beach, South Carolina, 29572, United States

Location

Local Site # 840111

Garland, Texas, 75044, United States

Location

Local Site # 840103

Katy, Texas, 77484, United States

Location

Local Site # 840110

Lubbock, Texas, 79410, United States

Location

Local Site # 840114

Lubbock, Texas, 79424, United States

Location

Local Site # 840102

Southlake, Texas, 76092, United States

Location

Local Site # 840101

Tyler, Texas, 75701, United States

Location

Local Site # 840126

West Jordan, Utah, 84088, United States

Location

Local Site # 036106

Concord, NSW 2139, Australia

Location

Local Site # 036103

Melbourne, VIC 3004, Australia

Location

Local Site # 036104

Melbourne, VIC 3011, Australia

Location

Local Site # 036101

Melbourne, VIC 3065, Australia

Location

Local Site # 036102

Parkville, VIC 3050, Australia

Location

Local Site # 036105

Perth, WA 6150, Australia

Location

Local Site # 076102

Taguatinga, Federal District, 72145-450, Brazil

Location

Local Site # 076104

Porto Alegre, Rio Grande Do Su, 90035-903, Brazil

Location

Local Site # 076106

Curitiba, 80230-130, Brazil

Location

Local Site # 076107

Curitiba, 80420-090, Brazil

Location

Local Site # 076101

Santo André, 09080-110, Brazil

Location

Local Site # 076103

São Paulo, 04543-011, Brazil

Location

Local Site # 076105

São Paulo, 076105, Brazil

Location

Local Site # 100102

Rousse, 7000, Bulgaria

Location

Local Site # 100103

Sofia, 1527, Bulgaria

Location

Local Site # 100101

Sofia, 1784, Bulgaria

Location

Local Site # 124103

Oakville, Ontario, L6L 5L7, Canada

Location

Local Site # 124104

Oshawa, Ontario, l1J 0C7, Canada

Location

Local Site # 124101

Toronto, Ontario, M6A 3B4, Canada

Location

Local Site # 124102

Woodbridge, Ontario, L4L 4Y7, Canada

Location

Local Site # 203106

Brno, 602 00, Czechia

Location

Local Site # 203102

Brno, 636 00, Czechia

Location

Local Site # 203105

Hradec Králové, 500 12, Czechia

Location

Local Site # 203104

Ostrava, 708 52, Czechia

Location

Local Site # 203101

Slaný, 274 01, Czechia

Location

Local Site # 203103

Ústí nad Labem, 401 13, Czechia

Location

Local Site # 268105

Tbilisi, 0101, Georgia

Location

Local Site # 268103

Tbilisi, 0160, Georgia

Location

Local Site # 268101

Tbilisi, 0180, Georgia

Location

Local Site # 276102

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Local Site # 276105

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Local Site # 276106

Duisburg, North Rhine-Westphalia, 47055, Germany

Location

Local Site # 276109

Berlin, 14050, Germany

Location

Local Site # 276104

Berlin, Germany

Location

Local Site # 276108

Hessen, 60431, Germany

Location

Local Site # 276107

Kiel, 24105, Germany

Location

Local Site # 348102

Békéscsaba, H-5600, Hungary

Location

Local Site # 348101

Budapest, H-1033, Hungary

Location

Local Site # 348106

Gyöngyös, 3200, Hungary

Location

Local Site #348104

Szeged, 6725, Hungary

Location

Local Site # 348103

Szekszárd, H-7100, Hungary

Location

Local Site # 348105

Tatabánya, 2800, Hungary

Location

Local Site # 376103

Ashkelon, 7830604, Israel

Location

Local Site # 376108

Haifa, 31048, Israel

Location

Local Site # 376105

Jerusalem, 9103102, Israel

Location

Local Site # 376107

Jerusalem, 9112001, Israel

Location

Local Site # 376101

Petah Tikva, 49100, Israel

Location

Local Site # 376102

Rehovot, 7661041, Israel

Location

Local Site # 380104

Milan, Lombardy, 20089, Italy

Location

Local Site # 380105

Negrar, Verona, 37024, Italy

Location

Local Site # 380101

Bari, 470013, Italy

Location

Local Site # 380107

Milan, 20132, Italy

Location

Local Site # 380109

Rome, 00168, Italy

Location

Local Site # 380106

Turin, 10128, Italy

Location

Local Site # 440101

Vilnius, LT-08661, Lithuania

Location

Local Site # 498101

Chisinau, MD-2025, Moldova

Location

Local Site # 498102

Chisinau, MD-2025, Moldova

Location

Local Site # 616116

Bydgoszcz, 85-794, Poland

Location

Local Site #616113

Knurów, 44-190, Poland

Location

Local Site # 616112

Krakow, 31-501, Poland

Location

Local Site # 616110

Lodz, 90-752, Poland

Location

Local Site # 616105

Lodz, 91-034, Poland

Location

Local Site # 616101

Lodz, 91-495, Poland

Location

Local Site # 616117

Lublin, 20-412, Poland

Location

Local Site # 616109

Nowy Targ, 34-400, Poland

Location

Local Site # 616107

Oświęcim, 32-600, Poland

Location

Local Site # 616115

Poznan, 61-293, Poland

Location

Local Site # 616104

Rzeszów, 35-326, Poland

Location

Local Site # 616118

Staszów, 28-200, Poland

Location

Local Site # 616106

Szczecin, 71-434, Poland

Location

Local Site # 616102

Warsaw, 00-728, Poland

Location

Local Site # 616114

Wroclaw, 50-088, Poland

Location

Local Site # 616103

Wroclaw, 52-416, Poland

Location

Local Site # 616108

Wroclaw, 54-144, Poland

Location

Local Site # 703103

Bratislava, 811 09, Slovakia

Location

Locla Site # 703101

Košice, 040 13, Slovakia

Location

Local Site # 703106

Martin, 03659, Slovakia

Location

Local Site # 703104

Prešov, 080 01, Slovakia

Location

Local Site # 703102

Šahy, 936 01, Slovakia

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Snehal Naik, PhD

  Ventyx Biosciences, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will employ a double-blind design. Participants, Investigators, study center staff, persons performing the assessments, and the Sponsor are to remain blinded to the identity of the Induction and Maintenance Period treatment from the time of randomization until the interim database lock for the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 18, 2023
• Study Start: January 25, 2023
• Primary Completion: June 27, 2024
• Study Completion: December 20, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

BU (3); IT (6); AU (6); GE (3); HU (6); LI (1); US (26); IL (6); BR (7); DE (7); MO (2); SL (5); CZ (6); PL (17); CA (4)