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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05621317




Registration number
NCT05621317
Ethics application status
Date submitted
27/10/2022
Date registered
18/11/2022

Titles & IDs
Public title
A Safety and Efficacy Study of PVX108 in Children and Adolescents with Peanut Allergy
Scientific title
A Safety and Efficacy Study of PVX108 in Children and Adolescents with Peanut Allergy
Secondary ID [1] 0 0
AVX-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut Allergy 0 0
Peanut Hypersensitivity 0 0
Peanut-Induced Anaphylaxis 0 0
Immune System Diseases 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PVX-108
Treatment: Other - Placebo

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

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

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

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

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


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

Treatment: Other: Placebo
Matching placebo comprises the formulation vehicle without peptides
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
46 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
71 weeks
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
46 weeks
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
71 weeks
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
46 weeks
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
71 weeks
Secondary outcome [6] 0 0
Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Timepoint [6] 0 0
46 weeks
Secondary outcome [7] 0 0
Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Timepoint [7] 0 0
71 weeks
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
46 weeks
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
71 weeks
Secondary outcome [10] 0 0
Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) during 45 weeks treatment and 26 weeks following treatment with PVX108 compared to placebo
Timepoint [10] 0 0
Up to 74 weeks
Secondary outcome [11] 0 0
Change from baseline in peak expiratory flow
Timepoint [11] 0 0
Up to 73 weeks
Secondary outcome [12] 0 0
Severity of symptoms upon unintentional exposure to peanut (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007)
Timepoint [12] 0 0
Up to 73 weeks
Secondary outcome [13] 0 0
Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs
Timepoint [13] 0 0
Up to 46 weeks
Secondary outcome [14] 0 0
Number of participants with abnormal physical examination data
Timepoint [14] 0 0
Up to 74 weeks
Secondary outcome [15] 0 0
Incidence of concomitant medication use
Timepoint [15] 0 0
Up to 74 weeks
Secondary outcome [16] 0 0
Number of participants with abnormal clinical laboratory data
Timepoint [16] 0 0
Up to 74 weeks
Secondary outcome [17] 0 0
Number of participants with abnormal vital signs
Timepoint [17] 0 0
Up to 74 weeks

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
The Royal Children's Hospital Melbourne - Parkville
Recruitment hospital [6] 0 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
- North Adelaide
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aravax Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian Vickery, MD
Address 0 0
Emory University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05621317