Clinical trial NCT04492683: Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cow's Milk Allergy
Keywords: Non-IgE mediated CMA
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 230
Sex: ALL
Minimum age (years): 29
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Diagnostic performance of DBV1605
timeFrame: 48 hours
measure: Diagnostic performance of DBV1605
timeFrame: 72 hours
Secondary outcomes:
measure: Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
timeFrame: Up to day 49
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Titan Clinical Research
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Health Science
state: Arizona
city: San Diego
country: United States
facility: University of California, Rady Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Hialeah
country: United States
facility: Eastern Research Inc.
state: Florida
city: Miami
country: United States
facility: Biomedical Research, LLC
state: Florida
city: Opa-locka
country: United States
facility: Sunshine Research Center
state: Florida
city: Columbus
country: United States
facility: Allergy Center at Brookstone - Research Department
state: Georgia
city: Lafayette
country: United States
facility: MedPharmics, LLC - Lafayette
state: Louisiana
city: Boston
country: United States
facility: Massachusets General Hospital
state: Massachusetts
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Roy
country: United States
facility: Alliance for Multispecialty Research, LLC - New Roy Office
state: Utah
city: Burlington
country: Canada
facility: Halton Pediatric Allergy
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Allergy
state: Ontario
city: North York
country: Canada
facility: Gordon Sussman Clinical Research Inc.
state: Ontario
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina
city: Pavia
country: Italy
facility: IRCCS Fondazione Policlinico San Matteo - Pediatria
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesù
city: Roma
country: Italy
facility: Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics
Study officials:
References: