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Trial record 1 of 1 for:    NCT02916446
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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 : Active, not recruiting
First Posted : September 27, 2016
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date May 7, 2020
Study Start Date  ICMJE October 2016
Actual Primary Completion Date September 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Through study completion, an average of 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 27, 2016)
  • Change in peanut-specific Immunoglobulins E (IgE) [ Time Frame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42 ]
  • Change in peanut-specific Immunoglobulins G4 (IgG4) [ Time Frame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42 ]
Original Other Pre-specified Outcome Measures
 (submitted: September 26, 2016)
Change in peanut-specific Immunoglobulins E (IgE) and immunoglobulins G4 (IgG4) [ Time Frame: Baseline, month 3, 6, 9, 12, 18, 24, 30, 36, 42 ]
 
Descriptive Information
Brief Title  ICMJE Safety Study of Viaskin Peanut to Treat Peanut Allergy
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • Biological: Viaskin Peanut 250 mcg
  • Biological: Placebo
Study Arms  ICMJE
  • Experimental: Viaskin Peanut 250 mcg
    Viaskin Peanut 250 mcg, daily administration
    Intervention: Biological: Viaskin Peanut 250 mcg
  • Placebo Comparator: Placebo
    Placebo patch, daily administration
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 13, 2017)
393
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2016)
335
Estimated Study Completion Date  ICMJE September 2020
Actual Primary Completion Date September 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916446
Other Study ID Numbers  ICMJE REALISE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DBV Technologies
Study Sponsor  ICMJE DBV Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DBV Technologies
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP