A Study to Assess the Biological Potency of Peanut Allerg... | NCT03352726

Studies
A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects

NCT03352726

Sponsor

DBV Technologies

Status

Completed

Last Update Posted

Jul 26, 2019Actual

Enrollment

27Actual

Phase

Phase 1

Conditions

Peanut Allergy

Interventions

DBV712 IHRP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2017Actual

Primary Completion Date

Jun 29, 2018Actual

Completion Date

Jun 29, 2018Actual

First Submitted Date

Nov 21, 2017

First Submission Date that Met QC Criteria

Nov 22, 2017

First Posted Date

Nov 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2019

Last Update Posted Date

Jul 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DBV712 Solution for Skin Prick Test	Experimental	DBV712 In-House Reference Skin Prick Test preparation	Drug: DBV712 IHRP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DBV712 IHRP	Drug	DBV712 Solution for Skin Prick Test	DBV712 Solution for Skin Prick Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU)		1 day to 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)		Throughout the study (1 day to 2 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

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

Main Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital		Little Rock	Arkansas	72202	United States
Children's Hospital Colorado

Condition Browse Module

MeSH Terms

ID	Term
D021183	Peanut Hypersensitivity

Ancestor Terms

ID	Term
D000074924	Nut and Peanut Hypersensitivity
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity

Browse Leaves

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Browse Branches

Not provided