A Safety and Efficacy Study of PVX108 in Children and Adolescents with Peanut Allergy
- Conditions
- Peanut-Induced AnaphylaxisPeanut HypersensitivityPeanut AllergyImmune System Diseases
- Interventions
- Biological: Placebo
- Registration Number
- NCT05621317
- Lead Sponsor
- Aravax Pty Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo in adolescents Placebo Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1) PVX108 50 nmol in adolescents PVX-108 Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1) PVX108 50 nmol in children PVX-108 Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2) Placebo in children Placebo Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2) PVX108 5 nmol in children PVX-108 Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo 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 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 71 weeks Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo 46 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 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 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) Up to 73 weeks Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs Up to 46 weeks Number of participants with abnormal physical examination data Up to 74 weeks Incidence of concomitant medication use Up to 74 weeks Number of participants with abnormal vital signs Up to 74 weeks Number of participants with abnormal clinical laboratory data Up to 74 weeks
Trial Locations
- Locations (14)
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Riley Children's Hospital at IU
🇺🇸Indianapolis, Indiana, United States
IAA Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Perth Children's Hospital
🇦🇺Nedlands, Western Australia, Australia
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Queensland Children's Hospital
🇦🇺South Brisbane, Queensland, Australia
Arkansas Children's Research Institute
🇺🇸Little Rock, Arkansas, United States
The Royal Children's Hospital Melbourne
🇦🇺Parkville, Victoria, Australia
Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States