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

Cow's Milk Allergy Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492683
• Other study ID #: V1605-201
• Status: Recruiting
• Phase: Phase 2
• Start date: August 28, 2020
• Est. completion date: March 2024

Study information

• Verified date: December 2021
• Source: DBV Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Days to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
Canada	Halton Pediatric Allergy	Burlington	Ontario
Canada	Hamilton Allergy	Hamilton	Ontario
Canada	Gordon Sussman Clinical Research Inc.	North York	Ontario
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Azienda Ospedaliera di Padova	Padova
Italy	UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina	Palermo
Italy	IRCCS Fondazione Policlinico San Matteo - Pediatria	Pavia
Italy	Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara	Pisa
Italy	IRCCS Ospedale Pediatrico Bambino Gesù	Roma
Italy	Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica	Roma
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma	Verona
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno Klinikos	Kaunas
Lithuania	Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics	Vilnius
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Massachusets General Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Allergy Center at Brookstone - Research Department	Columbus	Georgia
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Eastern Research Inc.	Hialeah	Florida
United States	MedPharmics, LLC - Lafayette	Lafayette	Louisiana
United States	Biomedical Research, LLC	Miami	Florida
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	Sunshine Research Center	Opa-locka	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Titan Clinical Research	Phoenix	Arizona
United States	University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)	Rochester	New York
United States	Alliance for Multispecialty Research, LLC - New Roy Office	Roy	Utah
United States	University of California, Rady Children's Hospital	San Diego	California
United States	University of Arizona Health Science	Tucson	Arizona
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
DBV Technologies

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours
Primary	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.	72 hours
Secondary	Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)		Up to day 49