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Completed

NCT Number: NCT02916446

Safety Study of Viaskin Peanut to Treat Peanut Allergy

This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.

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Key information

Conditions

Peanut Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's and Women's Health Centre of Brisith Columbia, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician-diagnosed peanut allergy;
  • A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm;
  • A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L;
  • Subjects following a strict peanut-free diet.

Exclusion criteria

  • Generalized dermatologic disease
  • Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted value, or peak expiratory flow (PEF) <80% of predicted value;
  • Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy;
  • Prior or concomitant history of any immunotherapy to any food allergy (for example EPIT, OIT, SLIT, or specific oral tolerance induction).

Treatment and study plan

Viaskin Peanut 250 mcg

Biological

Placebo

Biological

Primary outcomes

  1. Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Through study completion, an average of 3 years

Other outcomes

  1. Change in peanut-specific Immunoglobulins E (IgE)

    Time frame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42

  2. Change in peanut-specific Immunoglobulins G4 (IgG4)

    Time frame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42

Sponsors and collaborators

Lead sponsor

DBV Technologies

Industry

Registry information

Acronym: REALISE

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Sep 27, 2016
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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