Crohn DiseasePhase 2Harmony-CDNCT05688852
VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease
A Phase 2 study testing VTX958 in people with Crohn Disease, run by Ventyx Biosciences, Inc at 105 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- VTX958
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 105 sitesin 15 countries
- Study dates
- 25 Jan 2023to 20 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
105 sites in 15 countries.
105 sites in 15 countries
United States26 sites
Local Site # 840112
Atlanta, Georgia, 30342
Local Site # 840117
Chevy Chase, Maryland, 20815
Local Site # 840122
Columbus, Ohio, 43202
Local Site # 840105
Garden Grove, California, 92845
Local Site # 840111
Garland, Texas, 75044
Local Site # 840115
Glenview, Illinois, 60026
Local Site # 840107
Gurnee, Illinois, 60031
Local Site # 840103
Katy, Texas, 77484
Local Site # 840124
Kissimmee, Florida, 34744
Local Site # 840109
Lancaster, California, 93534
Local Site # 840116
Liberty, Missouri, 64068
Local Site # 840127
Louisville, Kentucky, 40218
Local Site # 840110
Lubbock, Texas, 79410
Local Site # 840114
Lubbock, Texas, 79424
Local Site # 840104
Miami, Florida, 33165
Local Site # 840123
Myrtle Beach, South Carolina, 29572
Local Site # 840119
New Albany, Indiana, 47150
Local Site # 840106
Oklahoma City, Oklahoma, 73102
Local Site # 840108
Orlando, Florida, 32806
Local Site # 840125
Orlando, Florida, 32825
Local Site # 840118
Rockville, Maryland, 20850
Local Site # 840113
Shreveport, Louisiana, 71105
Local Site # 840102
Southlake, Texas, 76092
Local Site # 840101
Tyler, Texas, 75701
Local Site # 840126
West Jordan, Utah, 84088
Local Site # 840121
Winston-Salem, North Carolina, 27103
Poland17 sites
Local Site # 616116
Bydgoszcz, 85-794
Local Site #616113
Knurów, 44-190
Local Site # 616112
Krakow, 31-501
Local Site # 616110
Lodz, 90-752
Local Site # 616105
Lodz, 91-034
Local Site # 616101
Lodz, 91-495
Local Site # 616117
Lublin, 20-412
Local Site # 616109
Nowy Targ, 34-400
Local Site # 616107
Oświęcim, 32-600
Local Site # 616115
Poznan, 61-293
Local Site # 616104
Rzeszów, 35-326
Local Site # 616118
Staszów, 28-200
Local Site # 616106
Szczecin, 71-434
Local Site # 616102
Warsaw, 00-728
Local Site # 616114
Wroclaw, 50-088
Local Site # 616103
Wroclaw, 52-416
Local Site # 616108
Wroclaw, 54-144
Brazil7 sites
Local Site # 076106
Curitiba, 80230-130
Local Site # 076107
Curitiba, 80420-090
Local Site # 076104
Porto Alegre, Rio Grande Do Su, 90035-903
Local Site # 076101
Santo André, 09080-110
Local Site # 076103
São Paulo, 04543-011
Local Site # 076105
São Paulo, 076105
Local Site # 076102
Taguatinga, Federal District, 72145-450
Germany7 sites
Local Site # 276109
Berlin, 14050
Local Site # 276104
Berlin
Local Site # 276106
Duisburg, North Rhine-Westphalia, 47055
Local Site # 276108
Hessen, 60431
Local Site # 276107
Kiel, 24105
Local Site # 276102
Tübingen, Baden-Wurttemberg, 72076
Local Site # 276105
Ulm, Baden-Wurttemberg, 89081
Australia6 sites
Local Site # 036106
Concord, NSW 2139
Local Site # 036103
Melbourne, VIC 3004
Local Site # 036104
Melbourne, VIC 3011
Local Site # 036101
Melbourne, VIC 3065
Local Site # 036102
Parkville, VIC 3050
Local Site # 036105
Perth, WA 6150
Czechia6 sites
Local Site # 203106
Brno, 602 00
Local Site # 203102
Brno, 636 00
Local Site # 203105
Hradec Králové, 500 12
Local Site # 203104
Ostrava, 708 52
Local Site # 203101
Slaný, 274 01
Local Site # 203103
Ústí nad Labem, 401 13
Hungary6 sites
Local Site # 348102
Békéscsaba, H-5600
Local Site # 348101
Budapest, H-1033
Local Site # 348106
Gyöngyös, 3200
Local Site #348104
Szeged, 6725
Local Site # 348103
Szekszárd, H-7100
Local Site # 348105
Tatabánya, 2800
Israel6 sites
Local Site # 376103
Ashkelon, 7830604
Local Site # 376108
Haifa, 31048
Local Site # 376105
Jerusalem, 9103102
Local Site # 376107
Jerusalem, 9112001
Local Site # 376101
Petah Tikva, 49100
Local Site # 376102
Rehovot, 7661041
Italy6 sites
Local Site # 380101
Bari, 470013
Local Site # 380104
Milan, Lombardy, 20089
Local Site # 380107
Milan, 20132
Local Site # 380105
Negrar, Verona, 37024
Local Site # 380109
Rome, 00168
Local Site # 380106
Turin, 10128
Slovakia5 sites
Local Site # 703103
Bratislava, 811 09
Locla Site # 703101
Košice, 040 13
Local Site # 703106
Martin, 03659
Local Site # 703104
Prešov, 080 01
Local Site # 703102
Šahy, 936 01
Canada4 sites
Local Site # 124103
Oakville, Ontario, L6L 5L7
Local Site # 124104
Oshawa, Ontario, l1J 0C7
Local Site # 124101
Toronto, Ontario, M6A 3B4
Local Site # 124102
Woodbridge, Ontario, L4L 4Y7
Bulgaria3 sites
Local Site # 100102
Rousse, 7000
Local Site # 100103
Sofia, 1527
Local Site # 100101
Sofia, 1784
Georgia3 sites
Local Site # 268105
Tbilisi, 0101
Local Site # 268103
Tbilisi, 0160
Local Site # 268101
Tbilisi, 0180
Moldova2 sites
Local Site # 498101
Chisinau, MD-2025
Local Site # 498102
Chisinau, MD-2025
About this study
Official title: 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.
Read the 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
- Conditions
- Crohn Disease
- Being tested
- VTX958, VTX958 Placebo
- Keywords
- VTX958, Harmony, Crohn's disease, TYK2
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTX958Drug
Dose A VTX958
VTX958Drug
Dose B VTX958
VTX958 PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| VTX958 Dose A | Experimental | Not described Receives: Drug: VTX958 |
| VTX958 Dose B | Experimental | Not described Receives: Drug: VTX958 |
| VTX958 Placebo | Placebo comparator | Not described Receives: Drug: VTX958 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During screening to week 12
Secondary outcomes (6)
The proportion of participants achieving endoscopic response at 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.
Measured: During screening to week 12
Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at 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.
Measured: During screening to week 12
Proportion of participants achieving clinical remission at 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.
Measured: During screening to week 12
Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at 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
Measured: During screening to week 12
Proportion of participants achieving clinical response at 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.
Measured: During screening to week 12
Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at 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.
Measured: During screening to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start25 Jan 2023
- Primary completion27 Jun 2024
- Study completion20 Dec 2024
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ventyx Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Snehal Naik, PhD, Study director, Ventyx Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688852
- Sponsor's protocol ID
- VTX958-202
- Acronym
- Harmony-CD
- Status last verified
- Jul 2025
- First submitted
- 5 Jan 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05688852
- Acronym / sponsor ID
- Harmony-CD / VTX958-202
- Conditions
- Crohn Disease
- Keywords
- VTX958, Harmony, Crohn's disease, TYK2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ventyx Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VTX958 Dose A | Experimental | Drug: VTX958 |
| VTX958 Dose B | Experimental | Drug: VTX958 |
| VTX958 Placebo | Placebo comparator | Drug: VTX958 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VTX958Dose A VTX958 | Drug | VTX958 Dose A |
| VTX958Dose B VTX958 | Drug | VTX958 Dose B |
| VTX958 PlaceboPlacebo | Drug | VTX958 Placebo |
Primary outcome
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.
6 secondary outcomes
The proportion of participants achieving endoscopic response at Week 12
Time frame: 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
Proportion of participants achieving clinical remission at Week 12
Time frame: 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
Proportion of participants achieving clinical response at Week 12
Time frame: 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
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snehal Naik, PhD study director
Ventyx Biosciences, Inc
105 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VTX958 in people with Crohn Disease, run by Ventyx Biosciences, Inc at 105 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in United States, Poland, Brazil, Germany, Australia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12 (time frame: During screening to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.