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

Aravax

Status and phase: Invitation-only; Phase 2

Conditions: Peanut Allergy; Peanut-Induced Anaphylaxis; Immune System Diseases; Peanut Hypersensitivity

Treatments: Biological: Placebo; Biological: PVX-108

Study type: Interventional

Funder types: Industry

Identifiers

NCT05621317

AVX-201

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 5 patient groups, including a placebo group

PVX108 50 nmol in adolescents

Experimental group

Description:

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

Treatment:

Biological: PVX-108

Placebo in adolescents

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

PVX108 5 nmol in children

Experimental group

Description:

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

Treatment:

Biological: PVX-108

PVX108 50 nmol in children

Experimental group

Description:

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

Treatment:

Biological: PVX-108

Placebo in children

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo