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Trial record 6 of 19 for:    Food Allergy | Dallas, Texas, U.S.

Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children (PEOPLE)

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: NCT03013517
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Brief Summary:
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: Viaskin Peanut 250µg Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
Actual Study Start Date : January 23, 2017
Actual Primary Completion Date : November 23, 2019
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Viaskin Peanut 250µg Drug: Viaskin Peanut 250µg
DBV712 250 µg, once daily




Primary Outcome Measures :
  1. % of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE [ Time Frame: Month 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who completed the PEPITES study.

Exclusion Criteria:

  • Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
  • Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.

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): NCT03013517


Locations
Show Show 31 study locations
Sponsors and Collaborators
DBV Technologies
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Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT03013517    
Other Study ID Numbers: PEOPLE
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DBV Technologies:
Allergy
food allergy
viaskin
peanut
epicutaneous
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate