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Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children (APTITUDE)

Primary Purpose

Cow's Milk Allergy

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DBV1605
Sponsored by
DBV Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cow's Milk Allergy focused on measuring Non-IgE mediated CMA

Eligibility Criteria

29 Days - 24 Months (Child)All SexesAccepts Healthy Volunteers

DISEASE GROUP

Inclusion Criteria:

  • Male or female subjects aged > 28 days to ≤ 24 months at Screening Visit
  • Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy
  • Subjects with any type of diet containing daily products with cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) prior to Screening Visit or who have started a cow's milk elimination diet not more than 4 weeks prior to Screening Visit,
  • Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other mammalian milks (such as sheep and goat's milk) as per study requirements.

Exclusion Criteria:

  • Subjects with an established diagnosis of non-IgE mediated CMA
  • Breast-fed subject at Screening Visit
  • Subjects with a convincing history of IgE-mediated CMA
  • Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula initiated more than 4 weeks prior to Screening Visit.
  • Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on the skin.
  • Any contraindication to a cow's milk challenge

CONTROL GROUP

Inclusion Criteria:

  • Male or female subjects aged > 28 days to ≤ 24 months at Screening visit
  • Subjects having no medical history of any type of allergy
  • Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 4 weeks prior to Screening visit

Exclusion Criteria:

  • Subjects with history of persistent gastro-intestinal symptoms
  • Exclusively breast-fed subjects at Screening visit

Sites / Locations

  • Titan Clinical ResearchRecruiting
  • University of Arizona Health ScienceRecruiting
  • University of California, Rady Children's Hospital
  • Children's Hospital Colorado
  • Children's National Medical CenterRecruiting
  • Eastern Research Inc.
  • Biomedical Research, LLCRecruiting
  • Sunshine Research Center
  • Allergy Center at Brookstone - Research Department
  • MedPharmics, LLC - LafayetteRecruiting
  • Massachusets General HospitalRecruiting
  • New York University Langone Medical CenterRecruiting
  • Icahn School of Medicine at Mount Sinai
  • University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
  • Cincinnati Children's Hospital Medical Center
  • Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical CenterRecruiting
  • Nationwide Children's HospitalRecruiting
  • Allergy, Asthma & Clinical Research CenterRecruiting
  • Children's Hospital of Philadelphia
  • Alliance for Multispecialty Research, LLC - New Roy Office
  • Halton Pediatric AllergyRecruiting
  • Hamilton AllergyRecruiting
  • Gordon Sussman Clinical Research Inc.
  • Azienda Ospedaliera Universitaria Federico IIRecruiting
  • Azienda Ospedaliera di PadovaRecruiting
  • UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di CristinaRecruiting
  • IRCCS Fondazione Policlinico San Matteo - PediatriaRecruiting
  • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa ChiaraRecruiting
  • IRCCS Ospedale Pediatrico Bambino Gesù
  • Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva PediatricaRecruiting
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo RomaRecruiting
  • Hospital of Lithuanian University of Health Sciences Kauno KlinikosRecruiting
  • Vilnius University Hospital Santaros Klinikos, Centre of PediatricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Disease group

Control group

Arm Description

One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA

One active patch and one control patch applied to subjects without any history of allergic disease

Outcomes

Primary Outcome Measures

Diagnostic performance of DBV1605
Sensitivity and specificity of DBV1605 based on skin reactivity readings after 48 hours will be compared to the results of the DBPCFC in subjects of the disease group.
Diagnostic performance of DBV1605
Sensitivity and specificity of DBV1605 based on skin reactivity readings after 72 hours will be compared to the results of the DBPCFC in subjects of the disease group.

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2020
Last Updated
August 9, 2022
Sponsor
DBV Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT04492683
Brief Title
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
Acronym
APTITUDE
Official Title
A Phase 2 Study to Evaluate the Sensitivity, Specificity and Safety of DBV1605, a Ready-to-Use Atopy Patch Test for the Diagnosis of Non-Immunoglobulin E Mediated Cow's Milk Allergy in Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DBV Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy
Keywords
Non-IgE mediated CMA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Disease group
Arm Type
Experimental
Arm Description
One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
Arm Title
Control group
Arm Type
Experimental
Arm Description
One active patch and one control patch applied to subjects without any history of allergic disease
Intervention Type
Combination Product
Intervention Name(s)
DBV1605
Intervention Description
Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches: One active patch containing a dry deposit of 180 μg of cow's milk proteins One control patch with the same design as the active patch but devoid of any formulation.
Primary Outcome Measure Information:
Title
Diagnostic performance of DBV1605
Description
Sensitivity and specificity of DBV1605 based on skin reactivity readings after 48 hours will be compared to the results of the DBPCFC in subjects of the disease group.
Time Frame
48 hours
Title
Diagnostic performance of DBV1605
Description
Sensitivity and specificity of DBV1605 based on skin reactivity readings after 72 hours will be compared to the results of the DBPCFC in subjects of the disease group.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Time Frame
Up to day 49

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE GROUP Inclusion Criteria: Male or female subjects aged > 28 days to ≤ 24 months at Screening Visit Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy Subjects with any type of diet containing daily products with cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) prior to Screening Visit or who have started a cow's milk elimination diet not more than 4 weeks prior to Screening Visit, Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other mammalian milks (such as sheep and goat's milk) as per study requirements. Exclusion Criteria: Subjects with an established diagnosis of non-IgE mediated CMA Breast-fed subject at Screening Visit Subjects with a convincing history of IgE-mediated CMA Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula initiated more than 4 weeks prior to Screening Visit. Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on the skin. Any contraindication to a cow's milk challenge CONTROL GROUP Inclusion Criteria: Male or female subjects aged > 28 days to ≤ 24 months at Screening visit Subjects having no medical history of any type of allergy Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 4 weeks prior to Screening visit Exclusion Criteria: Subjects with history of persistent gastro-intestinal symptoms Exclusively breast-fed subjects at Screening visit
Facility Information:
Facility Name
Titan Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yadwinder Dhillon, MD
Phone
623-262-0930
Email
y.dhillon@viableresearch.org
First Name & Middle Initial & Last Name & Degree
Yadwinder Dhillon, MD
Facility Name
University of Arizona Health Science
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Cassell, MD
Phone
520-626-8517
Email
heathercassell@peds.arizona.edu
First Name & Middle Initial & Last Name & Degree
Heather Cassell, MD
Facility Name
University of California, Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Leonard, MD
Phone
858-966-5961
Email
saleonard@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Leonard, MD
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Withdrawn
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hemant Sharma, MD
Phone
202-476-4416
Email
Hsharma@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Hemant Sharma, MD
Facility Name
Eastern Research Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Individual Site Status
Withdrawn
Facility Name
Biomedical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilia Roque Guerrero, MD
Phone
305-671-3686
Email
LroqueMD@Bio-MedicalResearch.com
First Name & Middle Initial & Last Name & Degree
Lilia Roque Guerrero
Facility Name
Sunshine Research Center
City
Opa-locka
State/Province
Florida
ZIP/Postal Code
33054
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Blemur, MD
Phone
305-688-0791
Email
maitemenendez@yahoo.com
First Name & Middle Initial & Last Name & Degree
Pierre Blemur, MD
Facility Name
Allergy Center at Brookstone - Research Department
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Withdrawn
Facility Name
MedPharmics, LLC - Lafayette
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jibran Atwi, MD
Phone
337-451-0663
Email
jibranatwi@medpharmics.com
First Name & Middle Initial & Last Name & Degree
Jibran Atwi, MD
Facility Name
Massachusets General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wayne Shreffler, MD
Phone
617-726-6147
Email
wshreffler@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Wayne Shreffler, MD
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Nowak-Wegzryn, MD
Phone
212-263-1255
Email
Anna.Nowak-wegrzyn@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Anna Nowak-Wegzryn, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Grace Baker, MD
Phone
212-241-5548
Email
marygrace.baker@mssm.edu
First Name & Middle Initial & Last Name & Degree
Mary Grace Baker, MD
Facility Name
University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsi M Jarvinen-Seppo, MD
Phone
585-276-7190
Email
Kirsi_Jarvinen-Seppo@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Kirsi M Jarvinen-Seppo, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal Assa'ad, MD
Phone
513-636-6771
Email
amal.assa'ad@cchmc.org
First Name & Middle Initial & Last Name & Degree
Amal Assa'ad, MD
Facility Name
Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Sferra, MD
Phone
216-844-1765
Ext
27860
Email
Thomas.Sferra@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Thomas Sferra, MD
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2664
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Stukus, MD
Phone
614-722-4808
Email
david.stukus@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
David Stukus, MD
Facility Name
Allergy, Asthma & Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Tarpay, MD
Phone
405-752-0393
Email
mtarpay@mtarpay.com
First Name & Middle Initial & Last Name & Degree
Martha Tarpay, MD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terri Brown-Whitehorn, MD
Phone
215-590-2549
Email
brownte@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Terri Brown-Whitehorn, MD
Facility Name
Alliance for Multispecialty Research, LLC - New Roy Office
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony G Pruitt, MD
Phone
801-773-8644
Email
Tony.pruitt@amrllc.com
First Name & Middle Initial & Last Name & Degree
Anthony G Pruitt, MD
Facility Name
Halton Pediatric Allergy
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7L 6W6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Mack, MD
Phone
9053159543
Email
dougpmack@gmail.com
First Name & Middle Initial & Last Name & Degree
Douglas Mack, MD
Facility Name
Hamilton Allergy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L4A 1S4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Ohayon, MD
Phone
905-525-4674
Email
ohayonj@hamiltonallergy.ca
First Name & Middle Initial & Last Name & Degree
Jason Ohayon, MD
Facility Name
Gordon Sussman Clinical Research Inc.
City
North York
State/Province
Ontario
ZIP/Postal Code
M3B 356
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani, MD
Phone
390 815451278
Email
berni@unina.it
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani, MD
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Muraro
Phone
39 335 7080827
Email
muraro@centroallergiealimentari.eu
First Name & Middle Initial & Last Name & Degree
Antonella Muraro, MD
Facility Name
UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina
City
Palermo
ZIP/Postal Code
90134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Cavataio
Phone
39 916666192
Email
francesca.cavataio@arnascivico.it
First Name & Middle Initial & Last Name & Degree
Francesca Cavataio, MD
Facility Name
IRCCS Fondazione Policlinico San Matteo - Pediatria
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amelia Licari, MD
Phone
39 0382502629
Email
a.licari@smatteo.pv.it
First Name & Middle Initial & Last Name & Degree
Amelia Licari, MD
Facility Name
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Peroni
Phone
39 050993180
Email
perodiego@gmail.com
First Name & Middle Initial & Last Name & Degree
Diego Peroni, MD
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesù
City
Roma
ZIP/Postal Code
00146
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Fiocchi, MD
Phone
39 06 6859 2309
Email
alessandro.fiocchi@allegriallergia.net
First Name & Middle Initial & Last Name & Degree
Alessandro Fiocchi, MD
Facility Name
Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Aloi, MD
Phone
39 0649979387
Email
marina.aloi@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Marina Aloi, MD
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Piacentini, MD
Phone
39 045 812 7120
Email
giorgio.piacentini@univr.it
First Name & Middle Initial & Last Name & Degree
Giorgio Piacentini, MD
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolanta Kudzyte, MD
Phone
37068685286
Email
jolantakudzyte@gmail.com
First Name & Middle Initial & Last Name & Degree
Jolanta Kudzyte, MD
Facility Name
Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odilija Rudzeviciene, MD
Phone
37060820243
Email
odilija.rudzeviciene@santa.lt
First Name & Middle Initial & Last Name & Degree
Odilija Rudzeviciene, MD

12. IPD Sharing Statement

Learn more about this trial

Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children

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