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

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ClinicalTrials.gov Identifier: NCT03013517
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : September 8, 2017
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
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
Study Start Date : January 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Viaskin Peanut 250µg Drug: Viaskin Peanut 250µg



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


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Sponsors and Collaborators
DBV Technologies

Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT03013517     History of Changes
Other Study ID Numbers: PEOPLE
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Keywords provided by DBV Technologies:
Allergy
food allergy
viaskin
peanut
epicutaneous

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate