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Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

Study Purpose

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year - 3 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

- Male or female from 1-3 years of age; - Physician-diagnosed peanut allergy; - Peanut-specific IgE level > 0.7 kU/L; - Positive peanut SPT with a largest wheal diameter ≥ 6 mm; - Positive DBPCFC at ≤ 300 mg peanut protein; Key

Exclusion Criteria:

- Uncontrolled asthma; - History of severe anaphylaxis to peanut; - Prior immunotherapy to any food or other immunotherapy; - Generalized severe dermatologic disease;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03211247
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

DBV Technologies
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, France, Germany, Ireland, Netherlands, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Arms & Interventions

Arms

Experimental: Viaskin Peanut 250 mcg

Experimental: Viaskin Peanut 100 mcg

Placebo Comparator: Placebo

Interventions

Biological: - Viaskin Peanut 250 mcg

Viaskin Peanut 250 mcg, once daily

Biological: - Viaskin Peanut 100 mcg

Viaskin Peanut 100 mcg, once daily

Biological: - Placebo

Placebo patch, once daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona Health Science, Tucson, Arizona

Status

Recruiting

Address

University of Arizona Health Science

Tucson, Arizona, 85719

Site Contact

Heather Cassell, MD

heathercassell@peds.arizona.edu

520-626-7780

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Site Contact

Stacie M. Jones, MD

jonesstaciem@uams.edu

501-364-1060

Los Angeles, California

Status

Recruiting

Address

University of California School of Medicine

Los Angeles, California, 10833

Site Contact

Maria Garcia-Lloret, MD

Migarcia@mednet.ucla.edu

310-825-6481

San Diego, California

Status

Recruiting

Address

University of California, Rady Children's Hospital

San Diego, California, 92123

Site Contact

Stephanie Leonard, MD

saleonard@ucsd.edu

858-966-5961

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94158

Site Contact

Morna DORSEY, MD

Morna.Dorsey@ucsf.edu

415-476-3086

Stanford University School of Medicine, Stanford, California

Status

Recruiting

Address

Stanford University School of Medicine

Stanford, California, 94305

Site Contact

Sayantani Sindher

SNPCenterAllergy.Inquiry@stanford.edu

650-724-0293

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Site Contact

David M. Fleischer, MD

david.fleischer@childrenscolorado.org

720-777-2575

Children's national Health System, Washington, District of Columbia

Status

Recruiting

Address

Children's national Health System

Washington, District of Columbia, 20010

Site Contact

Hemant Sharma, MD

HSharma@childrensnational.org

202-476-6080

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30329

Site Contact

Brian VICKERY, MD

brian.p.vickery@emory.edu

404-727-8536

Chicago, Illinois

Status

Recruiting

Address

Ann & Robert H. Lurie Children's Hospital of CHicago

Chicago, Illinois, 60611

Site Contact

Michelle Catalano

allergystudy@luriechildrens.org

312-227-6474

The Universal of Chicago Medical Center, Chicago, Illinois

Status

Recruiting

Address

The Universal of Chicago Medical Center

Chicago, Illinois, 60637

Site Contact

Christina Ciaccio, MD

cciaccio@peds.bsd.uchicago.edu

773-834-4010

Indianapolis, Indiana

Status

Recruiting

Address

Riley Hospital for Children at Indiana University

Indianapolis, Indiana, 46202

Site Contact

Kirsten KLOEPFER, MD

kloepfer@iu.edu

317-278-7860

Johns Hopkins Hospital, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Hospital

Baltimore, Maryland, 21205

Site Contact

Robert Wood, MD

rwood@jhmi.edu

410-955-5883

Boston Childrens' Hospital, Boston, Massachusetts

Status

Recruiting

Address

Boston Childrens' Hospital

Boston, Massachusetts, 02115

Site Contact

Lynda Schneider, MD

lynda.schneider@childrens.harvard.edu

617-355-6180

University of Michigan Health System, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Health System

Ann Arbor, Michigan, 48106

Site Contact

Georgiana M Sanders, MD

gsanders@med.umich.edu

734-936-5634

Mount Sinai Medical Center, New York, New York

Status

Recruiting

Address

Mount Sinai Medical Center

New York, New York, 10029

Site Contact

Julie Wang, MD

julie.wang@mssm.edu

212-241-5548

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Jeanne Lomas, MD

Jeanne_Lomas@urmc.rochester.edu

716-604-6928

Chapel Hill, North Carolina

Status

Recruiting

Address

The University of North Carolina - Chapell Hill

Chapel Hill, North Carolina, 27599

Site Contact

Edwin Kim, MD

edwinkim@med.unc.edu

919-843-9087

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Leigh Ann KERNS, MD

KernsL2@ccf.org

216-444-6340

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Terri Brown-Whitehorn, MD

brownte@email.chop.edu

215-590-2549

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213

Site Contact

Deborah Albright, MD

albrightd@chp.edu

412-692-8296

Le Bonheur Children's Hospital, Memphis, Tennessee

Status

Recruiting

Address

Le Bonheur Children's Hospital

Memphis, Tennessee, 38105

Site Contact

Jay LIEBERMAN, MD

jlieber1@uthsc.edu

901-287-7337

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Stacy Dorris, MD

stacy.l.dorris@vumc.org

615-936-5697

Dell Children's Medical Center, Austin, Texas

Status

Recruiting

Address

Dell Children's Medical Center

Austin, Texas, 78723

Site Contact

Pooja VARSHNEY, MD

pVarshney@ascension.org

512-628-1870

Children's Medical Center of Dallas, Dallas, Texas

Status

Recruiting

Address

Children's Medical Center of Dallas

Dallas, Texas, 75235

Site Contact

Christopher Parrish, MD

dChristopher.Parrish@UTSouthwestern.edu

214-456-5730

Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine - Texas Children's Hospital

Houston, Texas, 77030

Site Contact

Sara Anvari, MD

sanvari@bcm.edu

832-825-4668

ASTHMA, Inc., Seattle, Washington

Status

Recruiting

Address

ASTHMA, Inc.

Seattle, Washington, 98115

Site Contact

Daniel Petroni, MD

dpetroni@nwasthma.com

206-525-5520

International Sites

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Status

Recruiting

Address

The Children's Hospital at Westmead

Westmead, New South Wales, 2145

Site Contact

Lara Ford, MD

lford@med.usyd.edu.au

0468321005

Sydney Children's Hospital, Randwick, NWS, Australia

Status

Recruiting

Address

Sydney Children's Hospital

Randwick, NWS, 2031

Site Contact

Brynn Wainstein, MD

brynn.wainstein@health.nws.gov.au

0412826604

Queensland Children's Hospital, South Brisbane, Queensland, Australia

Status

Recruiting

Address

Queensland Children's Hospital

South Brisbane, Queensland, 4101

Site Contact

Jane Peake, MD

j.peake@uq.edu.au

0730681370

The Women's and children's hospital, North Adelaide, South Australia, Australia

Status

Recruiting

Address

The Women's and children's hospital

North Adelaide, South Australia, 5006

Site Contact

Patrick Quinn, MD

patrick.quinn@adelaide.edu.au

00610881616337

The Royal Children's Hospital, Parkville, Victoria, Australia

Status

Recruiting

Address

The Royal Children's Hospital

Parkville, Victoria, 3052

Site Contact

Kirsten Perrett, MD

kirsten.perrett@rch.org.au

0417342022

Perth Children's Hospital, Nedlands, Western Australia, Australia

Status

Recruiting

Address

Perth Children's Hospital

Nedlands, Western Australia, 6009

Site Contact

Michael O'sullivan, MD

Michael.O'Sullivan@health.wa.gov.au

0061403387081

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

Status

Recruiting

Address

British Columbia Children's Hospital

Vancouver, British Columbia, V5H 3V4

Site Contact

Chan Edmond, MD

EChan5@cw.bc.ca

1 604 875 2628

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Recruiting

Address

Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Site Contact

Thomas Eiwegger

thomas.eiwegger@sickkids.ca

416-813-7654

CHUM & CHU Sainte-Justine, Montréal, Quebec, Canada

Status

Recruiting

Address

CHUM & CHU Sainte-Justine

Montréal, Quebec, H3T 1C4

Site Contact

Philippe Begin

philippe.begin@umontreal.ca

514-567-9599

CHRU Lille, Lille, France

Status

Recruiting

Address

CHRU Lille

Lille, , 59037

Site Contact

Antoine Deschildre, MD

antoine.Deschildre@chru-lille.fr

0320445072

CHRU Metz-Thionville, Metz, France

Status

Recruiting

Address

CHRU Metz-Thionville

Metz, , 57085

Site Contact

Sebastien Lefevre, MD

s.lefevre@chr-metz-thionville.fr

0387553383

Hopitaux Pediatriques de Nice, Nice, France

Status

Recruiting

Address

Hopitaux Pediatriques de Nice

Nice, , 06200

Site Contact

Thierry Bourrier, MD

bourrier.t@pediatrie-chulenval-nice.fr

0492030533

Hopital Necker, Paris, France

Status

Recruiting

Address

Hopital Necker

Paris, , 75015

Site Contact

Guillaume Lezmi, MD

guillaume.lezmi@aphp.fr

0144494846

CHRU Nancy, Vandoeuvre les nancy, France

Status

Recruiting

Address

CHRU Nancy

Vandoeuvre les nancy, , 54511

Site Contact

Amandine Divaret-Chauveau, MD

a.chauveau@chru-nancy.fr

0383155230

Universitatsklinikum Carl Gustav Carus, Dresden, Germany

Status

Recruiting

Address

Universitatsklinikum Carl Gustav Carus

Dresden, , 01307

Site Contact

Christian Vogelberg, MD

christian.vogelberg@uniklinikum-dresden.de

3514585699

Universitatsklinikum Frankfurt, Frankfurt, Germany

Status

Recruiting

Address

Universitatsklinikum Frankfurt

Frankfurt, , 60590

Site Contact

Katharina Bluemchen, MD

katharina.bluemchen@kgu.de

15117191213

Universitatklinikum Giessen und Marburg, Marburg, Germany

Status

Recruiting

Address

Universitatklinikum Giessen und Marburg

Marburg, , 35033

Site Contact

Wolfgang Pfutzner, MD

wpfuetzn@med.uni-marburg.de

64215866474

Cork University Hospital, Cork, Ireland

Status

Recruiting

Address

Cork University Hospital

Cork, , T12YE02

Site Contact

Jonathan Hourihane, MD

j.hourihane@ucc.ie

353214903000

Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus MC Sophia Children's Hospital

Rotterdam, , 3015

Site Contact

Nicolette Arends, MD

n.arends@erasmusmc.nl

31107036263

London, United Kingdom

Status

Recruiting

Address

Guy's and Saint Thomas' NHS Foundation Trust

London, , SE17EH

Site Contact

George Du Toit, MD

george.dutoit@gstt.nhs.uk

02071880145

St.Mary's Hospital, London, United Kingdom

Status

Recruiting

Address

St.Mary's Hospital

London, , W21NY

Site Contact

Paul Turner, MD

p.turner@imperial.ac.uk

442033127754

ROyal Manchester Children's Hospital, Manchester, United Kingdom

Status

Recruiting

Address

ROyal Manchester Children's Hospital

Manchester, , M139WL

Site Contact

Peter Arkwright, MD

peter.Arkwright@nhs.net

441617010678

Sheffield Children's Hospital, Sheffield, United Kingdom

Status

Recruiting

Address

Sheffield Children's Hospital

Sheffield, , S102TH

Site Contact

Nicola Jay, MD

nicola.jay@nhs.net

07757698659

Southampton, United Kingdom

Status

Recruiting

Address

University Hospital Southampton NHS Foundation Trust

Southampton, , SO166YD

Site Contact

Michel Erlewyn-Lajeunesse, MD

mich.lajeunesse@soton.ac.uk

4402381204335

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