VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease (Harmony-CD)

July 1, 2025 updated by: Ventyx Biosciences, Inc

A Phase 2, 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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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. Approximately 93 eligible patients will be randomized, and randomization will be stratified by prior use of biologics for the treatment of CD (yes/no).

The study consists of a 30-day Screening Period, a 12-week double-blind Induction Treatment Period, a 40-week double-blind Maintenance Treatment Period, an Open-Label Extension (OLE) of up to 144 weeks, and a 30-day safety Follow-Up Period. The maximum duration of treatment will be 36 months, including the Induction, Maintenance, and OLE Periods. For all participants, a Follow-Up visit will be performed at 30 days after the last dose of study drug.

Objectives Primary Objectives

* Evaluate the efficacy of VTX958 in achieving reduction in Crohn's Disease Activity Index (CDAI) score at the end of the Induction Period

Secondary Objectives

  • Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response and remission at the end of the Induction Period
  • Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remission at the end of the Induction Period

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord, Australia, NSW 2139
        • Local Site # 036106
      • Melbourne, Australia, VIC 3004
        • Local Site # 036103
      • Melbourne, Australia, VIC 3011
        • Local Site # 036104
      • Melbourne, Australia, VIC 3065
        • Local Site # 036101
      • Parkville, Australia, VIC 3050
        • Local Site # 036102
      • Perth, Australia, WA 6150
        • Local Site # 036105
  • Brazil
      • Curitiba, Brazil, 80230-130
        • Local Site # 076106
      • Curitiba, Brazil, 80420-090
        • Local Site # 076107
      • Santo André, Brazil, 09080-110
        • Local Site # 076101
      • São Paulo, Brazil, 04543-011
        • Local Site # 076103
      • São Paulo, Brazil, 076105
        • Local Site # 076105
    • Distrito Federal
      • Taguatinga, Distrito Federal, Brazil, 72145-450
        • Local Site # 076102
    • Rio Grande Do Su
      • Porto Alegre, Rio Grande Do Su, Brazil, 90035-903
        • Local Site # 076104
  • Bulgaria
      • Ruse, Bulgaria, 7000
        • Local Site # 100102
      • Sofia, Bulgaria, 1527
        • Local Site # 100103
      • Sofia, Bulgaria, 1784
        • Local Site # 100101
  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6L 5L7
        • Local Site # 124103
      • Oshawa, Ontario, Canada, l1J 0C7
        • Local Site # 124104
      • Toronto, Ontario, Canada, M6A 3B4
        • Local Site # 124101
      • Woodbridge, Ontario, Canada, L4L 4Y7
        • Local Site # 124102
  • Czechia
      • Brno, Czechia, 602 00
        • Local Site # 203106
      • Brno, Czechia, 636 00
        • Local Site # 203102
      • Hradec Králové, Czechia, 500 12
        • Local Site # 203105
      • Ostrava, Czechia, 708 52
        • Local Site # 203104
      • Slaný, Czechia, 274 01
        • Local Site # 203101
      • Ústí Nad Labem, Czechia, 401 13
        • Local Site # 203103
  • Georgia
      • Tbilisi, Georgia, 0101
        • Local Site # 268105
      • Tbilisi, Georgia, 0160
        • Local Site # 268103
      • Tbilisi, Georgia, 0180
        • Local Site # 268101
  • Germany
      • Berlin, Germany, 14050
        • Local Site # 276109
      • Berlin, Germany
        • Local Site # 276104
      • Hessen, Germany, 60431
        • Local Site # 276108
      • Kiel, Germany, 24105
        • Local Site # 276107
    • Baden-Wuerttemberg
      • Tuebingen, Baden-Wuerttemberg, Germany, 72076
        • Local Site # 276102
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Local Site # 276105
    • North Rhine-Westphalia
      • Duisburg, North Rhine-Westphalia, Germany, 47055
        • Local Site # 276106
  • Hungary
      • Budapest, Hungary, H-1033
        • Local Site # 348101
      • Békéscsaba, Hungary, H-5600
        • Local Site # 348102
      • Gyöngyös, Hungary, 3200
        • Local Site # 348106
      • Szeged, Hungary, 6725
        • Local Site #348104
      • Szekszárd, Hungary, H-7100
        • Local Site # 348103
      • Tatabánya, Hungary, 2800
        • Local Site # 348105
  • Israel
      • Ashkelon, Israel, 7830604
        • Local Site # 376103
      • Haifa, Israel, 31048
        • Local Site # 376108
      • Jerusalem, Israel, 9103102
        • Local Site # 376105
      • Jerusalem, Israel, 9112001
        • Local Site # 376107
      • Petah tikva, Israel, 49100
        • Local Site # 376101
      • Reẖovot, Israel, 7661041
        • Local Site # 376102
  • Italy
      • Bari, Italy, 470013
        • Local Site # 380101
      • Milan, Italy, 20132
        • Local Site # 380107
      • Rome, Italy, 00168
        • Local Site # 380109
      • Turin, Italy, 10128
        • Local Site # 380106
    • Lombardy
      • Milan, Lombardy, Italy, 20089
        • Local Site # 380104
    • Verona
      • Negrar, Verona, Italy, 37024
        • Local Site # 380105
  • Lithuania
      • Vilnius, Lithuania, LT-08661
        • Local Site # 440101
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD-2025
        • Local Site # 498101
      • Chisinau, Moldova, Republic of, MD-2025
        • Local Site # 498102
  • Poland
      • Bydgoszcz, Poland, 85-794
        • Local Site # 616116
      • Knurów, Poland, 44-190
        • Local Site #616113
      • Kraków, Poland, 31-501
        • Local Site # 616112
      • Lublin, Poland, 20-412
        • Local Site # 616117
      • Nowy Targ, Poland, 34-400
        • Local Site # 616109
      • Oświęcim, Poland, 32-600
        • Local Site # 616107
      • Poznan, Poland, 61-293
        • Local Site # 616115
      • Rzeszów, Poland, 35-326
        • Local Site # 616104
      • Staszów, Poland, 28-200
        • Local Site # 616118
      • Szczecin, Poland, 71-434
        • Local Site # 616106
      • Warsaw, Poland, 00-728
        • Local Site # 616102
      • Wrocław, Poland, 50-088
        • Local Site # 616114
      • Wrocław, Poland, 52-416
        • Local Site # 616103
      • Wrocław, Poland, 54-144
        • Local Site # 616108
      • Łódź, Poland, 90-752
        • Local Site # 616110
      • Łódź, Poland, 91-034
        • Local Site # 616105
      • Łódź, Poland, 91-495
        • Local Site # 616101
  • Slovakia
      • Bratislava, Slovakia, 811 09
        • Local Site # 703103
      • Košice, Slovakia, 040 13
        • Locla Site # 703101
      • Martin, Slovakia, 03659
        • Local Site # 703106
      • Prešov, Slovakia, 080 01
        • Local Site # 703104
      • Šahy, Slovakia, 936 01
        • Local Site # 703102
  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Local Site # 840105
      • Lancaster, California, United States, 93534
        • Local Site # 840109
    • Florida
      • Kissimmee, Florida, United States, 34744
        • Local Site # 840124
      • Miami, Florida, United States, 33165
        • Local Site # 840104
      • Orlando, Florida, United States, 32806
        • Local Site # 840108
      • Orlando, Florida, United States, 32825
        • Local Site # 840125
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Site # 840112
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Local Site # 840115
      • Gurnee, Illinois, United States, 60031
        • Local Site # 840107
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Local Site # 840119
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Local Site # 840127
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Local Site # 840113
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Local Site # 840117
      • Rockville, Maryland, United States, 20850
        • Local Site # 840118
    • Missouri
      • Liberty, Missouri, United States, 64068
        • Local Site # 840116
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Local Site # 840121
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Local Site # 840122
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Local Site # 840106
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Local Site # 840123
    • Texas
      • Garland, Texas, United States, 75044
        • Local Site # 840111
      • Katy, Texas, United States, 77484
        • Local Site # 840103
      • Lubbock, Texas, United States, 79410
        • Local Site # 840110
      • Lubbock, Texas, United States, 79424
        • Local Site # 840114
      • Southlake, Texas, United States, 76092
        • Local Site # 840102
      • Tyler, Texas, United States, 75701
        • Local Site # 840101
    • Utah
      • West Jordan, Utah, United States, 84088
        • Local Site # 840126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
  2. Presence of a stoma or ileoanal pouch
  3. 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
  4. Known diagnosis of short gut or bowel syndrome
  5. Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VTX958 Dose A
Drug: VTX958
Dose A VTX958
Drug: VTX958
Dose B VTX958
Experimental: VTX958 Dose B
Drug: VTX958
Dose A VTX958
Drug: VTX958
Dose B VTX958
Placebo Comparator: VTX958 Placebo
Drug: VTX958 Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12
Time Frame: During screening 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants achieving endoscopic response at Week 12
Time Frame: During screening to week 12
SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.
During screening to week 12
Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12
Time Frame: During screening to week 12
Change from baseline in mean simple endoscopic score in Crohn's disease SED-CD at 12 weeks. The SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.
During screening to week 12
Proportion of participants achieving clinical remission at Week 12
Time Frame: During screening to week 12
Clinical remission is defined as a CDAI score < 150. 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
Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12
Time Frame: During screening to week 12
The proportion of participants achieving PRO2 remission at week 12. PRO2 remission is defined is an unweighted CDAI component of daily AP score ≤ 1 and unweighted CDAI component of daily average stool frequency (SF) score ≤ 3
During screening to week 12
Proportion of participants achieving clinical response at Week 12
Time Frame: During screening to week 12
Proportion of participants achieving clinical response at Week 12. A clinical response is defined as ≥ 100 points reduction from baseline in CDAI score or CDAI score < 150. 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
Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12
Time Frame: During screening to week 12
Proportion of participants achieving both endoscopic response (as described in outcome measure 2) and clinical remission (as described in outcome measure 4) at Week 12.
During screening to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ventyx Biosciences, Inc

Investigators

  • Study Director: Snehal Naik, PhD, Ventyx Biosciences, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Actual)

June 27, 2024

Study Completion (Actual)

December 20, 2024

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTX958-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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