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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05688852




Registration number
NCT05688852
Ethics application status
Date submitted
5/01/2023
Date registered
18/01/2023
Date last updated
18/04/2024

Titles & IDs
Public title
VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
VTX958-202
Universal Trial Number (UTN)
Trial acronym
Harmony-CD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VTX958
Treatment: Drugs - VTX958
Treatment: Drugs - VTX958 Placebo

Experimental: VTX958 Dose A -

Experimental: VTX958 Dose B -

Placebo comparator: VTX958 Placebo -


Treatment: Drugs: VTX958
Dose A VTX958

Treatment: Drugs: VTX958
Dose B VTX958

Treatment: Drugs: VTX958 Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12
Timepoint [1] 0 0
During screening to week 12
Primary outcome [2] 0 0
The proportion of participants achieving endoscopic response at Week 12
Timepoint [2] 0 0
During screening to week 12
Secondary outcome [1] 0 0
Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12
Timepoint [1] 0 0
During screening to week 12
Secondary outcome [2] 0 0
Proportion of participants achieving clinical remission at Week 12
Timepoint [2] 0 0
During screening to week 12
Secondary outcome [3] 0 0
Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12
Timepoint [3] 0 0
During screening to week 12
Secondary outcome [4] 0 0
Proportion of participants achieving clinical response at Week 12
Timepoint [4] 0 0
During screening to week 12
Secondary outcome [5] 0 0
Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12
Timepoint [5] 0 0
During screening to week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Local Site # 036106 - Concord
Recruitment hospital [2] 0 0
Local Site # 036103 - Melbourne
Recruitment hospital [3] 0 0
Local Site # 036104 - Melbourne
Recruitment hospital [4] 0 0
Local Site # 036101 - Melbourne
Recruitment hospital [5] 0 0
Local Site # 036102 - Parkville
Recruitment hospital [6] 0 0
Local Site # 036105 - Perth
Recruitment postcode(s) [1] 0 0
NSW 2139 - Concord
Recruitment postcode(s) [2] 0 0
VIC 3004 - Melbourne
Recruitment postcode(s) [3] 0 0
VIC 3011 - Melbourne
Recruitment postcode(s) [4] 0 0
VIC 3065 - Melbourne
Recruitment postcode(s) [5] 0 0
VIC 3050 - Parkville
Recruitment postcode(s) [6] 0 0
WA 6150 - Perth
Recruitment outside Australia
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United States of America
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California
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maryland
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Missouri
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North Carolina
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Ohio
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Oklahoma
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South Carolina
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Texas
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Utah
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Brazil
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Distrito Federal
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Rio Grande Do Su
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Curitiba
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Vilnius
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Moldova, Republic of
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Chisinau
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Knurów
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Lublin
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Košice
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Martin
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Prešov
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Šahy

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ventyx Biosciences, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05688852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05688852