October 27, 2022
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November 18, 2022
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April 24, 2024
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February 9, 2023
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November 2024 (Final data collection date for primary outcome measure)
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Ratio of maximum tolerated dose (MTD) of peanut protein at the Week 46 double blind placebo-controlled food challenge (DBPCFC) relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
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Same as current
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- Ratio of MTD of peanut protein at the Week 71 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
- Percentage of children aged 4 to 11 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 46 DBPCFC compared to placebo [ Time Frame: 46 weeks ]
- Percentage of children aged 4 to 11 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 71 DBPCFC compared to placebo [ Time Frame: 71 weeks ]
- Ratio of cumulative reactive dose (CRD) of peanut protein at the Week 46 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
- Ratio of CRD of peanut protein at the Week 71 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
- Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
- Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
- Frequency of events of each severity grade during the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
- Frequency of events of each severity grade during the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
- Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) during 45 weeks treatment and 26 weeks following treatment with PVX108 compared to placebo [ Time Frame: Up to 74 weeks ]
Incidence and severity of TEAEs (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007) including SAEs, TEAEs leading to study discontinuation, anaphylaxis with temporal association to investigational product (IP) administration, use of epinephrine (adrenaline) as rescue medication after IP administration, and injection site reactions.
- Change from baseline in peak expiratory flow [ Time Frame: Up to 73 weeks ]
- Severity of symptoms upon unintentional exposure to peanut (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007) [ Time Frame: Up to 73 weeks ]
- Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs [ Time Frame: Up to 46 weeks ]
- Number of participants with abnormal physical examination data [ Time Frame: Up to 74 weeks ]
- Incidence of concomitant medication use [ Time Frame: Up to 74 weeks ]
- Number of participants with abnormal clinical laboratory data [ Time Frame: Up to 74 weeks ]
- Number of participants with abnormal vital signs [ Time Frame: Up to 74 weeks ]
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Same as current
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- Ratio of MTD of peanut protein at the Week 46 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
- Ratio of MTD of peanut protein at the Week 71 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
- Percentage of adolescents aged 12 to 17 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 46 DBPCFC compared to placebo [ Time Frame: 46 weeks ]
- Percentage of adolescents aged 12 to 17 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 71 DBPCFC compared to placebo [ Time Frame: 71 weeks ]
- Ratio of CRD of peanut protein at Week 46 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
- Ratio of CRD of peanut protein at Week 71 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
- Percentage of treatment responders at the Week 46 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
- Percentage of treatment responders at the Week 71 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
- Frequency of events of each severity grade during the Week 46 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
- Frequency of events of each severity grade during the Week 71 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
- Changes from baseline in allergen specific immunoglobulins after 45 weeks treatment with PVX108 compared to placebo [ Time Frame: Up to 74 weeks ]
- Changes from baseline in cellular immune response after 45 weeks treatment with PVX108 compared to placebo: Exploratory [ Time Frame: Up to 74 weeks ]
- Changes from baseline in titrated peanut skin prick test (SPT) response after 45 weeks treatment with PVX108 compared to placebo [ Time Frame: Up to 74 weeks ]
- Proportion of participants in each cohort who develop treatment-induced or treatment-enhanced ADAs during 45 weeks treatment with PVX108 compared to placebo [ Time Frame: 45 weeks ]
- Change from baseline in Food Allergy Related Quality of Life Questionnaire Child Form (FAQLQ-CF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
- Change from baseline in FAQLQ-Teenager Form (FAQLQ-TF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
- Change from baseline in Food Allergy Independent Measure (FAIM) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
- Change from baseline in FAIM score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
- Change from baseline in FAQLQ-Parent Form (FAQLP-PF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
- Change from baseline in FAQLQ-Parent Form Teenager (FAQLQ-PFT) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
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Same as current
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A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
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A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
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The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.
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Not Provided
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Interventional
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Phase 2
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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- Peanut Allergy
- Peanut Hypersensitivity
- Peanut-Induced Anaphylaxis
- Immune System Diseases
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- Experimental: PVX108 50 nmol in adolescents
Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1)
Intervention: Biological: PVX-108
- Placebo Comparator: Placebo in adolescents
Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1)
Intervention: Biological: Placebo
- Experimental: PVX108 5 nmol in children
Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)
Intervention: Biological: PVX-108
- Experimental: PVX108 50 nmol in children
Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2)
Intervention: Biological: PVX-108
- Placebo Comparator: Placebo in children
Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2)
Intervention: Biological: Placebo
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Not Provided
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Recruiting
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90
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Same as current
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July 2025
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November 2024 (Final data collection date for primary outcome measure)
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Key Inclusion Criteria:
- Physician-diagnosed immunoglobulin E (IgE) mediated peanut allergy;
- Peanut specific serum IgE measured by ImmunoCAP® ≥ 0.7 kilounit allergy specific antibody per litre (kUA/L) at screening;
- Positive skin prick test to peanut with mean wheal diameter ≥5 mm greater than negative control at screening;
- Positive peanut double blind placebo-controlled food challenge (DBPCFC) with a reactive dose ≤300 mg peanut protein (≤443 mg cumulative reactive dose [CRD]);
- Able to perform spirometry or peak expiratory flow. Children who are 4 years of age at Screening Stage 1 visit and unable to perform peak expiratory may be enrolled providing they had no clinical features of moderate or severe persistent asthma within 1 year prior to the Screening visit;
- Forced expiratory volume in 1 second (FEV1) ≥80% predicted in adolescents and children with asthma capable of performing spirometry, or peak expiratory flow ≥80% predicted in participants with asthma unable to perform spirometry (at investigator's discretion).
Key Exclusion Criteria:
- History of or current clinically significant medical conditions or laboratory abnormalities which in the opinion of the investigator would jeopardise the safety of the participant or the validity of the study results;
- Severe or unstable asthma as assessed by the Global Initiative for Asthma (GINA) assessment of asthma control OR current treatment for asthma at GINA ≥Step 4 level;
- Participants with skin disorders that would hinder skin prick testing and/or its interpretation or study drug administration (eg, severe generalised poorly controllable atopic dermatitis);
- Any medical condition in which epinephrine (adrenaline) is contraindicated;
- Prior therapy aimed at desensitising peanut allergy, either in a formal study or in clinical practice;
- Severe or life-threatening reaction during the screening food challenge, at investigator discretion.
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Sexes Eligible for Study: |
All |
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4 Years to 17 Years (Child)
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No
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Australia, United States
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NCT05621317
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AVX-201
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Aravax Pty Ltd
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Same as current
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Aravax Pty Ltd
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Same as current
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Not Provided
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Principal Investigator: |
Brian Vickery, MD |
Emory University |
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Aravax Pty Ltd
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February 2024
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