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

Sponsor

DBV Technologies (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03211247

Collaborator

(none)

414

Enrollment

Locations

Arms

Anticipated Duration (Months)

8.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Peanut Allergy	Biological: Viaskin Peanut 250 mcg Biological: Viaskin Peanut 100 mcg Biological: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

414 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

Actual Study Start Date :

Jul 31, 2017

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Viaskin Peanut 250 mcg	Biological: Viaskin Peanut 250 mcg Viaskin Peanut 250 mcg, once daily
Experimental: Viaskin Peanut 100 mcg	Biological: Viaskin Peanut 100 mcg Viaskin Peanut 100 mcg, once daily
Placebo Comparator: Placebo	Biological: Placebo Placebo patch, once daily

Arm

Intervention/Treatment

Experimental: Viaskin Peanut 250 mcg

Biological: Viaskin Peanut 250 mcg

Viaskin Peanut 250 mcg, once daily

Experimental: Viaskin Peanut 100 mcg

Biological: Viaskin Peanut 100 mcg

Viaskin Peanut 100 mcg, once daily

Placebo Comparator: Placebo

Biological: Placebo

Placebo patch, once daily

Outcome Measures

Primary Outcome Measures

Differences between the percentage of treatment responders in the selected active Viaskin Peanut group compared to the placebo group. [Month 12]

Other Outcome Measures

Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) [Throughout the study during 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Health Science	Tucson	Arizona	United States	85719
2	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202
3	University of California School of Medicine	Los Angeles	California	United States	10833
4	University of California, Rady Children's Hospital	San Diego	California	United States	92123
5	University of California San Francisco	San Francisco	California	United States	94158
6	Stanford University School of Medicine	Stanford	California	United States	94305
7	Children's Hospital Colorado	Aurora	Colorado	United States	80045
8	Children's national Health System	Washington	District of Columbia	United States	20010
9	Emory University	Atlanta	Georgia	United States	30329
10	Ann & Robert H. Lurie Children's Hospital of CHicago	Chicago	Illinois	United States	60611
11	The Universal of Chicago Medical Center	Chicago	Illinois	United States	60637
12	Riley Hospital for Children at Indiana University	Indianapolis	Indiana	United States	46202
13	Johns Hopkins Hospital	Baltimore	Maryland	United States	21205
14	Boston Childrens' Hospital	Boston	Massachusetts	United States	02115
15	University of Michigan Health System	Ann Arbor	Michigan	United States	48106
16	Mount Sinai Medical Center	New York	New York	United States	10029
17	University of Rochester	Rochester	New York	United States	14642
18	The University of North Carolina - Chapell Hill	Chapel Hill	North Carolina	United States	27599
19	Cleveland Clinic	Cleveland	Ohio	United States	44195
20	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
21	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
22	Le Bonheur Children's Hospital	Memphis	Tennessee	United States	38105
23	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
24	Dell Children's Medical Center	Austin	Texas	United States	78723
25	Children's Medical Center of Dallas	Dallas	Texas	United States	75235
26	Baylor College of Medicine - Texas Children's Hospital	Houston	Texas	United States	77030
27	ASTHMA, Inc.	Seattle	Washington	United States	98115
28	The Children's Hospital at Westmead	Westmead	New South Wales	Australia	2145
29	Sydney Children's Hospital	Randwick	NWS	Australia	2031
30	Queensland Children's Hospital	South Brisbane	Queensland	Australia	4101
31	The Women's and children's hospital	North Adelaide	South Australia	Australia	5006
32	The Royal Children's Hospital	Parkville	Victoria	Australia	3052
33	Perth Children's Hospital	Nedlands	Western Australia	Australia	6009
34	British Columbia Children's Hospital	Vancouver	British Columbia	Canada	V5H 3V4
35	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8
36	CHUM & CHU Sainte-Justine	Montréal	Quebec	Canada	H3T 1C4
37	CHRU Lille	Lille		France	59037
38	CHRU Metz-Thionville	Metz		France	57085
39	Hopitaux Pediatriques de Nice	Nice		France	06200
40	Hopital Necker	Paris		France	75015
41	CHRU Nancy	Vandoeuvre les nancy		France	54511
42	Universitatsklinikum Carl Gustav Carus	Dresden		Germany	01307
43	Universitatsklinikum Frankfurt	Frankfurt		Germany	60590
44	Universitatklinikum Giessen und Marburg	Marburg		Germany	35033
45	Cork University Hospital	Cork		Ireland	T12YE02
46	Erasmus MC Sophia Children's Hospital	Rotterdam		Netherlands	3015
47	Guy's and Saint Thomas' NHS Foundation Trust	London		United Kingdom	SE17EH
48	St.Mary's Hospital	London		United Kingdom	W21NY
49	ROyal Manchester Children's Hospital	Manchester		United Kingdom	M139WL
50	Sheffield Children's Hospital	Sheffield		United Kingdom	S102TH
51	University Hospital Southampton NHS Foundation Trust	Southampton		United Kingdom	SO166YD

Sponsors and Collaborators

DBV Technologies

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

DBV Technologies

ClinicalTrials.gov Identifier:

NCT03211247

Other Study ID Numbers:

EPITOPE

First Posted:

Jul 7, 2017

Last Update Posted:

Apr 26, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by DBV Technologies

Additional relevant MeSH terms:

Peanut Hypersensitivity

Study Results

No Results Posted as of Apr 26, 2021