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

NCT04492683 | Unknown Phase 2 FDA Drug

• 1 other identifier: V1605-201
• Study Type: interventional
• Target: 230
• Locations: 4 countries
• Sites: 33

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.

Conditions

Cow's Milk Allergy

Keywords

Non-IgE mediated CMA

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)

  Up to day 49

Study Arms (2)

Disease group

EXPERIMENTAL

One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA

Combination Product: DBV1605

Control group

EXPERIMENTAL

One active patch and one control patch applied to subjects without any history of allergic disease

Combination Product: DBV1605

Interventions

DBV1605 COMBINATION_PRODUCT

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.

Control group; Disease group

Eligibility Criteria

• Age: 29 Days - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Subjects with history of persistent gastro-intestinal symptoms
• Exclusively breast-fed subjects at Screening visit

Sponsors & Collaborators

• DBV Technologies: lead

Study Sites (33)

Titan Clinical Research

Phoenix, Arizona, 85004, United States

RECRUITING

University of Arizona Health Science

Tucson, Arizona, 85719, United States

RECRUITING

University of California, Rady Children's Hospital

San Diego, California, 92123, United States

NOT YET RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

WITHDRAWN

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2916, United States

RECRUITING

Eastern Research Inc.

Hialeah, Florida, 33013, United States

WITHDRAWN

Biomedical Research, LLC

Miami, Florida, 33184, United States

RECRUITING

Sunshine Research Center

Opa-locka, Florida, 33054, United States

NOT YET RECRUITING

Allergy Center at Brookstone - Research Department

Columbus, Georgia, 31904, United States

WITHDRAWN

MedPharmics, LLC - Lafayette

Lafayette, Louisiana, 70508, United States

RECRUITING

Massachusets General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

New York University Langone Medical Center

New York, New York, 10016, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)

Rochester, New York, 14642, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205-2664, United States

RECRUITING

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Alliance for Multispecialty Research, LLC - New Roy Office

Roy, Utah, 84067, United States

NOT YET RECRUITING

Halton Pediatric Allergy

Burlington, Ontario, L7L 6W6, Canada

RECRUITING

Hamilton Allergy

Hamilton, Ontario, L4A 1S4, Canada

RECRUITING

Gordon Sussman Clinical Research Inc.

North York, Ontario, M3B 356, Canada

WITHDRAWN

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

RECRUITING

Azienda Ospedaliera di Padova

Padua, 35128, Italy

RECRUITING

UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina

Palermo, 90134, Italy

RECRUITING

IRCCS Fondazione Policlinico San Matteo - Pediatria

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

Pisa, 56126, Italy

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, 00146, Italy

NOT YET RECRUITING

Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica

Roma, 00161, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

Verona, 37134, Italy

RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, 50161, Lithuania

RECRUITING

Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics

Vilnius, 08406, Lithuania

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 30, 2020
• Study Start: August 28, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 11, 2022

Record last verified: 2021-12

Locations

IT (8); LI (2); US (20); CA (3)