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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04492683
Other study ID # V1605-201
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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