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Safety Study of Viaskin Peanut to Treat Peanut Allergy (REALISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02916446
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: Viaskin Peanut 250 mcg Biological: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2016
Actual Primary Completion Date : September 22, 2017
Actual Study Completion Date : October 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, daily administration
 Biological: Viaskin Peanut 250 mcg
Placebo Comparator: Placebo
Placebo patch, daily administration
 Biological: Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916446


Locations
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Sponsors and Collaborators
DBV Technologies
More Information
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Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT02916446    
Other Study ID Numbers: REALISE
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
 Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate