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

Phase 2

• Conditions: Cow's Milk Allergy
• Interventions: Combination Product: DBV1605

• Registration Number: NCT04492683
• Lead Sponsor: DBV Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Study Start: 2020-08-28
• Status Verified: 2021-12
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-11
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disease group	DBV1605	One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
Control group	DBV1605	One active patch and one control patch applied to subjects without any history of allergic disease

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of DBV1605	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)	Up to day 49

Trial Locations

Locations (33)

Hamilton Allergy; 🇨🇦 Hamilton, Ontario, Canada

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Napoli, Italy

Allergy Center at Brookstone - Research Department; 🇺🇸 Columbus, Georgia, United States

University of Arizona Health Science; 🇺🇸 Tucson, Arizona, United States

MedPharmics, LLC - Lafayette; 🇺🇸 Lafayette, Louisiana, United States

Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica; 🇮🇹 Roma, Italy

IRCCS Fondazione Policlinico San Matteo - Pediatria; 🇮🇹 Pavia, Italy

Sunshine Research Center; 🇺🇸 Opa-locka, Florida, United States

IRCCS Ospedale Pediatrico Bambino Gesù; 🇮🇹 Roma, Italy

Eastern Research Inc.; 🇺🇸 Hialeah, Florida, United States

Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

New York University Langone Medical Center; 🇺🇸 New York, New York, United States

University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH); 🇺🇸 Rochester, New York, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Halton Pediatric Allergy; 🇨🇦 Burlington, Ontario, Canada

UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina; 🇮🇹 Palermo, Italy

Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara; 🇮🇹 Pisa, Italy

Titan Clinical Research; 🇺🇸 Phoenix, Arizona, United States

University of California, Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Biomedical Research, LLC; 🇺🇸 Miami, Florida, United States

Allergy, Asthma & Clinical Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics; 🇱🇹 Vilnius, Lithuania

Hospital of Lithuanian University of Health Sciences Kauno Klinikos; 🇱🇹 Kaunas, Lithuania

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma; 🇮🇹 Verona, Italy

Alliance for Multispecialty Research, LLC - New Roy Office; 🇺🇸 Roy, Utah, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Massachusets General Hospital; 🇺🇸 Boston, Massachusetts, United States

Gordon Sussman Clinical Research Inc.; 🇨🇦 North York, Ontario, Canada

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States