Peanut Allergy Clinical Trial
— EPOPEXOfficial title:
EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children
| Verified date | March 2022 |
| Source | DBV Technologies |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Open-label, follow-up study for subjects who completed the EPITOPE study.
| Status | Enrolling by invitation |
| Enrollment | 330 |
| Est. completion date | May 2025 |
| Est. primary completion date | June 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 5 Years |
| Eligibility | Inclusion Criteria: - completion of the EPITOPE study Exclusion Criteria: - Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches. - Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan - Allergy Specialty Clinic and Food Allergy Clinic | Ann Arbor | Michigan |
| United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
| United States | Children's Hospital Colorado | Aurora | Colorado |
| United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | Boston Childrens' Hospital | Boston | Massachusetts |
| United States | The University of North Carolina - Chapell Hill | Chapel Hill | North Carolina |
| United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
| United States | Comer Children's Hospital | Chicago | Illinois |
| United States | Children's Medical Center Dallas | Dallas | Texas |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Riley Hospital for Children | Indianapolis | Indiana |
| United States | Arkansas Children's Hospital | Little Rock | Arkansas |
| United States | David Geffen School of Medicine at University of California Los Angeles | Los Angeles | California |
| United States | Le Bonheur Children's Hospital | Memphis | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | University of Rochester | Rochester | New York |
| United States | Rady Children's Hospital San Diego | San Diego | California |
| United States | University of California San Francisco | San Francisco | California |
| United States | Seattle Allergy & Asthma Research Institute | Seattle | Washington |
| United States | Stanford University School of Medicine | Stanford | California |
| United States | Banner University Medical Center Tucson | Tucson | Arizona |
| United States | Children's National Health Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| DBV Technologies |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects reaching an ED =1000 mg | 12 months | ||
| Primary | Proportion of subjects reaching an ED =1000 mg | 24 months | ||
| Primary | Proportion of subjects reaching an ED =1000 mg | 36 months | ||
| Secondary | Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) | Throughout the study during 36 months |
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