NCT03352726

Brief Summary

The study aims to assess the biological potency of the In-House Reference Preparation (IHRP) of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 24, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

November 21, 2017

Last Update Submit

July 25, 2019

Conditions

Peanut Allergy

Keywords

EPITEpicutaneousImmunotherapyViaskin

Outcome Measures

Primary Outcomes (1)

  • Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)

    1 day to 2 weeks

Secondary Outcomes (1)

  • Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)

    Throughout the study (1 day to 2 weeks)

Study Arms (1)

DBV712 Solution for Skin Prick Test

EXPERIMENTAL

DBV712 In-House Reference Skin Prick Test preparation

Drug: DBV712 IHRP

Interventions

DBV712 IHRPDRUG

DBV712 Solution for Skin Prick Test

DBV712 Solution for Skin Prick Test

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female subjects aged between 12-50 years
  • Physician-diagnosed peanut allergy
  • Subject currently following a strict peanut-free diet
  • Documented history of positive test to peanut-specific IgE (ImmunoCAP system) \>0.7 kU/L
  • Positive peanut SPT with a largest wheal diameter ≥ 8 mm

You may not qualify if:

  • Uncontrolled asthma
  • Peanut allergen immunotherapy whatever the route, either ongoing or previously started and having lasted more than one month (\>30 days)
  • Topical use of steroids within the past 14 days prior to the Screening SPT
  • Inability to discontinue short-acting antihistamines
  • Atopic dermatitis, eczema or urticaria on the areas to be tested

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 24, 2017

Study Start

November 24, 2017

Primary Completion

June 29, 2018

Study Completion

June 29, 2018

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

US(2)