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

August 9, 2022 updated by: DBV Technologies

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Burlington, Ontario, Canada, L7L 6W6
        • Recruiting
        • Halton Pediatric Allergy
        • Contact:
        • Principal Investigator:
          • Douglas Mack, MD
      • Hamilton, Ontario, Canada, L4A 1S4
        • Recruiting
        • Hamilton Allergy
        • Contact:
        • Principal Investigator:
          • Jason Ohayon, MD
      • North York, Ontario, Canada, M3B 356
        • Withdrawn
        • Gordon Sussman Clinical Research Inc.
  • Italy
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Contact:
          • Roberto Berni Canani, MD
          • Phone Number: 390 815451278
          • Email: berni@unina.it
        • Principal Investigator:
          • Roberto Berni Canani, MD
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera di Padova
        • Contact:
        • Principal Investigator:
          • Antonella Muraro, MD
      • Palermo, Italy, 90134
        • Recruiting
        • UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina
        • Contact:
        • Principal Investigator:
          • Francesca Cavataio, MD
      • Pavia, Italy, 27100
        • Recruiting
        • IRCCS Fondazione Policlinico San Matteo - Pediatria
        • Contact:
        • Principal Investigator:
          • Amelia Licari, MD
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
        • Contact:
        • Principal Investigator:
          • Diego Peroni, MD
      • Roma, Italy, 00146
        • Not yet recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesu
        • Contact:
        • Principal Investigator:
          • Alessandro Fiocchi, MD
      • Roma, Italy, 00161
        • Recruiting
        • Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica
        • Contact:
        • Principal Investigator:
          • Marina Aloi, MD
      • Verona, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
        • Contact:
        • Principal Investigator:
          • Giorgio Piacentini, MD
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos
        • Contact:
        • Principal Investigator:
          • Jolanta Kudzyte, MD
      • Vilnius, Lithuania, 08406
        • Recruiting
        • Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics
        • Contact:
        • Principal Investigator:
          • Odilija Rudzeviciene, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Health Science
        • Contact:
        • Principal Investigator:
          • Heather Cassell, MD
    • California
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • University of California, Rady Children's Hospital
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Withdrawn
        • Children's Hospital Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2916
        • Recruiting
        • Children's National Medical Center
        • Contact:
        • Principal Investigator:
          • Hemant Sharma, MD
    • Florida
      • Hialeah, Florida, United States, 33013
        • Withdrawn
        • Eastern Research Inc.
      • Miami, Florida, United States, 33184
        • Recruiting
        • Biomedical Research, LLC
        • Contact:
        • Principal Investigator:
          • Lilia Roque Guerrero
      • Opa-locka, Florida, United States, 33054
        • Not yet recruiting
        • Sunshine Research Center
        • Contact:
        • Principal Investigator:
          • Pierre Blemur, MD
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Withdrawn
        • Allergy Center at Brookstone - Research Department
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusets General Hospital
        • Contact:
        • Principal Investigator:
          • Wayne Shreffler, MD
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Mary Grace Baker, MD
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Langone Medical Center
        • Contact:
        • Principal Investigator:
          • Anna Nowak-Wegzryn, MD
      • Rochester, New York, United States, 14642
        • Not yet recruiting
        • University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
        • Contact:
        • Principal Investigator:
          • Kirsi M Jarvinen-Seppo, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Not yet recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Amal Assa'ad, MD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center
        • Contact:
      • Columbus, Ohio, United States, 43205-2664
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
        • Principal Investigator:
          • David Stukus, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Allergy, Asthma & Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Martha Tarpay, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Terri Brown-Whitehorn, MD
    • Utah
      • Roy, Utah, United States, 84067
        • Not yet recruiting
        • Alliance for Multispecialty Research, LLC - New Roy Office
        • Contact:
        • Principal Investigator:
          • Anthony G Pruitt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Disease group
One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
Combination product: DBV1605

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.
EXPERIMENTAL: Control group
One active patch and one control patch applied to subjects without any history of allergic disease
Combination product: DBV1605

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of DBV1605
Time Frame: 48 hours
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.
48 hours
Diagnostic performance of DBV1605
Time Frame: 72 hours
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.
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Time Frame: Up to day 49
Up to day 49

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DBV Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2020

Primary Completion (ANTICIPATED)

March 1, 2024

Study Completion (ANTICIPATED)

March 1, 2024

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (ACTUAL)

July 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1605-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cow's Milk Allergy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe