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Cow's Milk AllergyPhase 2APTITUDENCT04492683

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

A Phase 2 study testing DBV1605 in people with Cow's Milk Allergy, run by DBV Technologies at 33 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 29 days to 24 monthsHealthy volunteers can take part
Conditions the study is for
Cow's Milk Allergy
What is being tested?
DBV1605
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
33 sitesin 4 countries
Study dates
28 Aug 2020to Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 29 days to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • CONTROL GROUP
  • Subjects with history of persistent gastro-intestinal symptoms
  • Exclusively breast-fed subjects at Screening visit

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

United States20 sites, 17 recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Withdrawn

  • Massachusets General Hospital

    Boston, Massachusetts, 02114

    Wayne Shreffler, MD, 617-726-6147, wshreffler@mgh.harvard.edu

    Wayne Shreffler, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Amal Assa'ad, MD, 513-636-6771, amal.assa'ad@cchmc.org

    Amal Assa'ad, MD

    Not yet recruiting

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

    Cleveland, Ohio, 44106

    Thomas Sferra, MD, 216-844-1765 ext. 27860, Thomas.Sferra@UHhospitals.org

    Thomas Sferra, MD

    Recruiting

  • Allergy Center at Brookstone - Research Department

    Columbus, Georgia, 31904

    Withdrawn

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205-2664

    David Stukus, MD, 614-722-4808, david.stukus@nationwidechildrens.org

    David Stukus, MD

    Recruiting

  • Eastern Research Inc.

    Hialeah, Florida, 33013

    Withdrawn

  • MedPharmics, LLC - Lafayette

    Lafayette, Louisiana, 70508

    Jibran Atwi, MD, 337-451-0663, jibranatwi@medpharmics.com

    Jibran Atwi, MD

    Recruiting

  • Biomedical Research, LLC

    Miami, Florida, 33184

    Lilia Roque Guerrero, MD, 305-671-3686, LroqueMD@Bio-MedicalResearch.com

    Lilia Roque Guerrero

    Recruiting

  • New York University Langone Medical Center

    New York, New York, 10016

    Anna Nowak-Wegzryn, MD, 212-263-1255, Anna.Nowak-wegrzyn@nyulangone.org

    Anna Nowak-Wegzryn, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Mary Grace Baker, MD, 212-241-5548, marygrace.baker@mssm.edu

    Mary Grace Baker, MD

    Not yet recruiting

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma, 73120

    Martha Tarpay, MD, 405-752-0393, mtarpay@mtarpay.com

    Martha Tarpay, MD

    Recruiting

  • Sunshine Research Center

    Opa-locka, Florida, 33054

    Pierre Blemur, MD, 305-688-0791, maitemenendez@yahoo.com

    Pierre Blemur, MD

    Not yet recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Terri Brown-Whitehorn, MD, 215-590-2549, brownte@email.chop.edu

    Terri Brown-Whitehorn, MD

    Not yet recruiting

  • Titan Clinical Research

    Phoenix, Arizona, 85004

    Yadwinder Dhillon, MD, 623-262-0930, y.dhillon@viableresearch.org

    Yadwinder Dhillon, MD

    Recruiting

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

    Rochester, New York, 14642

    Kirsi M Jarvinen-Seppo, MD, 585-276-7190, Kirsi_Jarvinen-Seppo@urmc.rochester.edu

    Kirsi M Jarvinen-Seppo, MD

    Not yet recruiting

  • Alliance for Multispecialty Research, LLC - New Roy Office

    Roy, Utah, 84067

    Anthony G Pruitt, MD, 801-773-8644, Tony.pruitt@amrllc.com

    Anthony G Pruitt, MD

    Not yet recruiting

  • University of California, Rady Children's Hospital

    San Diego, California, 92123

    Stephanie Leonard, MD, 858-966-5961, saleonard@ucsd.edu

    Stephanie Leonard, MD

    Not yet recruiting

  • University of Arizona Health Science

    Tucson, Arizona, 85719

    Heather Cassell, MD, 520-626-8517, heathercassell@peds.arizona.edu

    Heather Cassell, MD

    Recruiting

  • Children's National Medical Center

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

    Hemant Sharma, MD, 202-476-4416, Hsharma@childrensnational.org

    Hemant Sharma, MD

    Recruiting

Other trials in United States

Italy8 sites, 8 recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

    Roberto Berni Canani, MD, 390 815451278, berni@unina.it

    Roberto Berni Canani, MD

    Recruiting

  • Azienda Ospedaliera di Padova

    Padova, 35128

    Antonella Muraro, 39 335 7080827, muraro@centroallergiealimentari.eu

    Antonella Muraro, MD

    Recruiting

  • UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina

    Palermo, 90134

    Francesca Cavataio, 39 916666192, francesca.cavataio@arnascivico.it

    Francesca Cavataio, MD

    Recruiting

  • IRCCS Fondazione Policlinico San Matteo - Pediatria

    Pavia, 27100

    Amelia Licari, MD, 39 0382502629, a.licari@smatteo.pv.it

    Amelia Licari, MD

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

    Pisa, 56126

    Diego Peroni, 39 050993180, perodiego@gmail.com

    Diego Peroni, MD

    Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù

    Roma, 00146

    Alessandro Fiocchi, MD, 39 06 6859 2309, alessandro.fiocchi@allegriallergia.net

    Alessandro Fiocchi, MD

    Not yet recruiting

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

    Roma, 00161

    Marina Aloi, MD, 39 0649979387, marina.aloi@uniroma1.it

    Marina Aloi, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

    Verona, 37134

    Giorgio Piacentini, MD, 39 045 812 7120, giorgio.piacentini@univr.it

    Giorgio Piacentini, MD

    Recruiting

Other trials in Italy

Canada3 sites, 2 recruiting

  • Halton Pediatric Allergy

    Burlington, Ontario, L7L 6W6

    Douglas Mack, MD, 9053159543, dougpmack@gmail.com

    Douglas Mack, MD

    Recruiting

  • Hamilton Allergy

    Hamilton, Ontario, L4A 1S4

    Jason Ohayon, MD, 905-525-4674, ohayonj@hamiltonallergy.ca

    Jason Ohayon, MD

    Recruiting

  • Gordon Sussman Clinical Research Inc.

    North York, Ontario, M3B 356

    Withdrawn

Other trials in Canada

Lithuania2 sites, 2 recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, 50161

    Jolanta Kudzyte, MD, 37068685286, jolantakudzyte@gmail.com

    Jolanta Kudzyte, MD

    Recruiting

  • Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics

    Vilnius, 08406

    Odilija Rudzeviciene, MD, 37060820243, odilija.rudzeviciene@santa.lt

    Odilija Rudzeviciene, MD

    Recruiting

Other trials in Lithuania

About this study

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 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.

Being tested
DBV1605
Keywords
Non-IgE mediated CMA
Medical subject headings
Milk Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DBV1605Combination 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.
Study groups in NCT04492683
Study groupRoleWhat they receive
Disease groupExperimentalOne active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
Receives: Combination Product: DBV1605
Control groupExperimentalOne active patch and one control patch applied to subjects without any history of allergic disease
Receives: Combination Product: DBV1605

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 hours

  2. 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.

    Measured: 72 hours

Secondary outcomes (1)

  1. Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)

    Measured: Up to day 49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2020
  2. Study start28 Aug 2020
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04492683
Sponsor's protocol ID
V1605-201
Acronym
APTITUDE
Status last verified
Dec 2021
First submitted
23 Jul 2020
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DBV1605 in people with Cow's Milk Allergy, run by DBV Technologies at 33 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Italy, Canada, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic performance of DBV1605 (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04492683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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