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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05621317
Other study ID # AVX-201
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 9, 2023
Est. completion date July 2025

Study information

Verified date February 2024
Source Aravax Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility 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.

Study Design


Intervention

Biological:
PVX-108
PVX108 comprises a mixture of peptides that represent sequences from peanut allergens
Placebo
Matching placebo comprises the formulation vehicle without peptides

Locations

Country Name City State
Australia Perth Children's Hospital Nedlands Western Australia
Australia Women's and Children's Hospital North Adelaide South Australia
Australia The Royal Children's Hospital Melbourne Parkville Victoria
Australia Sydney Children's Hospital Randwick New South Wales
Australia The Children's Hospital at Westmead Westmead New South Wales
United States Children's Healthcare of Atlanta Atlanta Georgia
United States Johns Hopkins Hospital Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Arkansas Children's Research Institute Little Rock Arkansas
United States Peninsula Research Associates Rolling Hills Estates California

Sponsors (1)

Lead Sponsor Collaborator
Aravax Pty Ltd

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 46 weeks
Other 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 71 weeks
Other 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 46 weeks
Other 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 71 weeks
Other 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 46 weeks
Other 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 71 weeks
Other Percentage of treatment responders at the Week 46 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo 46 weeks
Other Percentage of treatment responders at the Week 71 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo 71 weeks
Other 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 46 weeks
Other 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 71 weeks
Other Changes from baseline in allergen specific immunoglobulins after 45 weeks treatment with PVX108 compared to placebo Up to 74 weeks
Other Changes from baseline in cellular immune response after 45 weeks treatment with PVX108 compared to placebo: Exploratory Up to 74 weeks
Other Changes from baseline in titrated peanut skin prick test (SPT) response after 45 weeks treatment with PVX108 compared to placebo Up to 74 weeks
Other Proportion of participants in each cohort who develop treatment-induced or treatment-enhanced ADAs during 45 weeks treatment with PVX108 compared to placebo 45 weeks
Other 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 Up to 71 weeks
Other 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 Up to 71 weeks
Other 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 Up to 71 weeks
Other 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 Up to 71 weeks
Other 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 Up to 71 weeks
Other 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 Up to 71 weeks
Primary 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 46 weeks
Secondary 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 71 weeks
Secondary 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 46 weeks
Secondary 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 71 weeks
Secondary 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 46 weeks
Secondary 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 71 weeks
Secondary Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo 46 weeks
Secondary Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo 71 weeks
Secondary 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 46 weeks
Secondary 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 71 weeks
Secondary Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) during 45 weeks treatment and 26 weeks following treatment with PVX108 compared to placebo 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. Up to 74 weeks
Secondary Change from baseline in peak expiratory flow Up to 73 weeks
Secondary Severity of symptoms upon unintentional exposure to peanut (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007) Up to 73 weeks
Secondary Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs Up to 46 weeks
Secondary Number of participants with abnormal physical examination data Up to 74 weeks
Secondary Incidence of concomitant medication use Up to 74 weeks
Secondary Number of participants with abnormal clinical laboratory data Up to 74 weeks
Secondary Number of participants with abnormal vital signs Up to 74 weeks
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