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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
Titles & IDs
Public title
VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease
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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
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Secondary ID [1]
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VTX958-202
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Universal Trial Number (UTN)
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Trial acronym
Harmony-CD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12
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Assessment method [1]
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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.
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Timepoint [1]
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During screening to week 12
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Primary outcome [2]
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The proportion of participants achieving endoscopic response at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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During screening to week 12
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Secondary outcome [1]
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Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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During screening to week 12
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Secondary outcome [2]
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Proportion of participants achieving clinical remission at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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During screening to week 12
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Secondary outcome [3]
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Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12
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Assessment method [3]
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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
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Timepoint [3]
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During screening to week 12
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Secondary outcome [4]
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Proportion of participants achieving clinical response at Week 12
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Assessment method [4]
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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.
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Timepoint [4]
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During screening to week 12
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Secondary outcome [5]
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Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12
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Assessment method [5]
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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.
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Timepoint [5]
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During screening to week 12
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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
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
132
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Local Site # 036106 - Concord
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Recruitment hospital [2]
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Local Site # 036103 - Melbourne
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Recruitment hospital [3]
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Local Site # 036104 - Melbourne
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Recruitment hospital [4]
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Local Site # 036101 - Melbourne
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Recruitment hospital [5]
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Local Site # 036102 - Parkville
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Recruitment hospital [6]
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Local Site # 036105 - Perth
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NSW 2139 - Concord
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Recruitment postcode(s) [2]
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VIC 3004 - Melbourne
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Recruitment postcode(s) [3]
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VIC 3011 - Melbourne
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Recruitment postcode(s) [4]
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VIC 3065 - Melbourne
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Recruitment postcode(s) [5]
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VIC 3050 - Parkville
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Recruitment postcode(s) [6]
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WA 6150 - Perth
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Recruitment outside Australia
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ventyx Biosciences, Inc
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05688852
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05688852