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Active, not recruiting Phase 2

A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy

NCT05621317 · tracked via the Priya Life Science USA tracker
Sponsor
Aravax Pty Ltd
Phase
Phase 2
Started
2023-02-09
Last updated
2025-10-15

Condition(s) studied

Peanut AllergyPeanut HypersensitivityPeanut-Induced AnaphylaxisImmune System Diseases

Investigational drug(s) / intervention(s)

PVX-108Placebo

PVX-108: PVX108 comprises a mixture of peptides that represent sequences from peanut allergens

Placebo: Matching placebo comprises the formulation vehicle without peptides

Study 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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (14)

FacilityCityRegionStatus
Arkansas Children's Research Institute Little Rock Arkansas
Peninsula Research Associates Rolling Hills Estates California
Children's Healthcare of Atlanta Atlanta Georgia
Riley Children's Hospital at IU Indianapolis Indiana
Johns Hopkins Hospital Baltimore Maryland
IAA Clinical Research Chevy Chase Maryland
Massachusetts General Hospital Boston Massachusetts
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Sydney Children's Hospital Randwick New South Wales
The Children's Hospital at Westmead Westmead New South Wales
Queensland Children's Hospital South Brisbane Queensland
Women's and Children's Hospital North Adelaide South Australia
The Royal Children's Hospital Melbourne Parkville Victoria
Perth Children's Hospital Nedlands Western Australia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05621317 on ClinicalTrials.gov ↗ ← All trials in the USA