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

Primary Purpose

Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis

Status
Recruiting
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
PVX-108
Placebo
Sponsored by
Aravax Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut allergy, Arachis, Child, Adolescent, Immunotherapy

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sydney Children's Hospital
  • The Children's Hospital at WestmeadRecruiting
  • Women's and Children's HospitalRecruiting
  • The Royal Children's Hospital MelbourneRecruiting
  • Perth Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

PVX108 50 nmol in adolescents

Placebo in adolescents

PVX108 5 nmol in children

PVX108 50 nmol in children

Placebo in children

Arm Description

Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1)

Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1)

Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)

Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2)

Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
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
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
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.
Change from baseline in peak expiratory flow
Severity of symptoms upon unintentional exposure to peanut (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007)
Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs
Number of participants with abnormal physical examination data
Incidence of concomitant medication use
Number of participants with abnormal clinical laboratory data
Number of participants with abnormal vital signs

Full Information

First Posted
October 27, 2022
Last Updated
May 5, 2023
Sponsor
Aravax Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05621317
Brief Title
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Official Title
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aravax Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis, Immune System Diseases
Keywords
Peanut allergy, Arachis, Child, Adolescent, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PVX108 50 nmol in adolescents
Arm Type
Experimental
Arm Description
Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1)
Arm Title
Placebo in adolescents
Arm Type
Placebo Comparator
Arm Description
Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1)
Arm Title
PVX108 5 nmol in children
Arm Type
Experimental
Arm Description
Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)
Arm Title
PVX108 50 nmol in children
Arm Type
Experimental
Arm Description
Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2)
Arm Title
Placebo in children
Arm Type
Placebo Comparator
Arm Description
Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2)
Intervention Type
Biological
Intervention Name(s)
PVX-108
Intervention Description
PVX108 comprises a mixture of peptides that represent sequences from peanut allergens
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Matching placebo comprises the formulation vehicle without peptides
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) during 45 weeks treatment and 26 weeks following treatment with PVX108 compared to placebo
Description
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.
Time Frame
Up to 74 weeks
Title
Change from baseline in peak expiratory flow
Time Frame
Up to 73 weeks
Title
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
Title
Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs
Time Frame
Up to 46 weeks
Title
Number of participants with abnormal physical examination data
Time Frame
Up to 74 weeks
Title
Incidence of concomitant medication use
Time Frame
Up to 74 weeks
Title
Number of participants with abnormal clinical laboratory data
Time Frame
Up to 74 weeks
Title
Number of participants with abnormal vital signs
Time Frame
Up to 74 weeks
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Changes from baseline in allergen specific immunoglobulins after 45 weeks treatment with PVX108 compared to placebo
Time Frame
Up to 74 weeks
Title
Changes from baseline in cellular immune response after 45 weeks treatment with PVX108 compared to placebo: Exploratory
Time Frame
Up to 74 weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Vickery, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wainstein
Phone
+61 (02) 9382 5534
Email
SCHN-SCHClinicalTrials@health.nsw.gov.au
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ford
Phone
+61 (02) 9845 3418
Email
SCHN-CHW-AllergyResearch@health.nsw.gov.au
Facility Name
Women's and Children's Hospital
City
North Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quinn
Phone
+61 (08) 8161 9156
Email
health.wchnallergyresearch@sa.gov.au
Facility Name
The Royal Children's Hospital Melbourne
City
Parkville
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrett
Phone
+61 (0)426 427 944
Email
aravax.peanut@mcri.edu.au
Facility Name
Perth Children's Hospital
City
Nedlands
State/Province
Western Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
O'Sullivan
Phone
+61(08) 6456 4360
Email
foodallergyresearch@health.wa.gov.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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