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

Immune System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621317
• Other study ID #: AVX-201
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Anaphylaxis
• Hypersensitivity
• Immune System Diseases
• Peanut Allergy
• Peanut Hypersensitivity

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