NCT01197053

Brief Summary

This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

4.5 years

First QC Date

September 7, 2010

Last Update Submit

October 18, 2015

Conditions

Peanut Allergy

Keywords

Peanut AllergyFood AllergyEpicutaneous Immunotherapy (EPIT)Food Challenge

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients able to consume >1000 mg of peanut proteins symptom-free

    Proportion of patients able to consume \>1000 mg of peanut proteins symptom-free during the double blind placebo-controlled food challenges (DBPCFC) to peanut at 6 months, or who have a 10-fold increase in the quantity of peanut proteins consumed as compared to baseline value

    6 months

Secondary Outcomes (4)

  • Description of the level of Ig

    6 months

  • Proportion of patients able to consume >1000 mg of peanut proteins symptom-free

    12 months

  • Proportion of patients able to consume >1000 mg of peanut proteins symptom-free

    18 months

  • diameter and safety

    3, 6, 12 and 18 months

Study Arms (2)

100 mcg DBV712 (active)

EXPERIMENTAL

100 mcg DBV712 administered epicutaneously every 24 hours.

Biological: Epicutaneous Immunotherapy

Placebo

PLACEBO COMPARATOR

Placebo will be administered epicutaneously every 24 hours

Biological: placebo of peanut

Interventions

Epicutaneous ImmunotherapyBIOLOGICAL

100 mcg peanut proteins (active arm) applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm

100 mcg DBV712 (active)
placebo of peanutBIOLOGICAL

placebo applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm

Placebo

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or Female between 5 and 17 years of age at enrollment
  • An efficient contraceptive method for girls with childbearing potential. Acceptable methods include sexual abstinence, oral, injectable contraceptive methods, intra uterine device.
  • Negative pregnancy test for girls with childbearing potential.
  • Child with a documented allergy to peanut, i.e. with peanut-specific IgE (\>5KU/L, ImmunoCAP method) and/or a positive skin prick test to peanut (wheal diameter ≥ 8mm).
  • Child able to consume a cumulated quantity of peanut proteins \<250 mg during the baseline DBPCFC.
  • Child and his/her legal representative(s) who provide a signed consent form and assent form.
  • Child and his/her legal representative(s) whose family and social conditions allow them to understand the protocol and agree to comply in the long term with all study requirements.

You may not qualify if:

  • Child considered too severely allergic to peanut: with a history of severe anaphylaxis to peanut (with hypotension, loss of consciousness, severe bradycardia, respiratory or cardiac arrest requiring an admission to emergency rooms).
  • Child with peanut-specific IgE\<5 KU/L and whose skin prick test to peanut gave a wheal diameter \<8mm).
  • Child participating or having participated in a therapeutic study in the last 3 months
  • Pregnancy or Breastfeeding
  • Child with a generalized eczema
  • Child with an immune deficiency
  • Diabetic child
  • Child allergic to chocolate
  • Child or legal representative(s) who did not sign their consent or assent
  • Child with no baseline DBPCFC
  • Child having reacted to placebo during the baseline DBPCFC
  • Child able to consume \> 250 mg of cumulated peanut proteins during the baseline DBPCFC
  • Child with a respiratory deficiency or with an uncontrolled asthma.
  • Child who could not discontinue oral or I.V. antihistamines or oral or I.V. corticosteroids at least the week prior to Visit 1.
  • Child with important skin lesions precluding the application of the disks.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Necker

Paris, 75015, France

Location

MeSH Terms

Conditions

Peanut HypersensitivityFood Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christophe Dupont, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

August 1, 2010

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

FR(1)