Treatment of patients diagnosed with peanut allergy Other
Conditions
Interventions
Period #1: Open-label Treatment Period: DBV712 250 µg
Regimen: 1 patch application per 24 hours
Route of administration: Cutaneous
Treatment duration: 36 months
Assigned Intervention #1: DBV712 250 µ
participants who consume at least the 600-650 mg peanut protein dose of FC without DLS (but don’t tolerate the entire FC) will be in Group 2
and participants who have DLS at or below the 600-650 mg dose will be in Group 3. These results will also determine the participant’s peanut consumption regimen for Months 37 to 48.
Group 1: Peanut C
Sponsors
DBV Technologies (France)
Eligibility
Sex/Gender
All
Age
6 Months to 12 Months
Inclusion criteria
Inclusion criteria: 1. Aged 6 through 12 months of age at Visit 1 (screening) 2. Weight =7 kg at Visit 1 3. Investigator-diagnosed peanut allergy 4. Currently following a strict peanut-free diet
Exclusion criteria
Exclusion criteria: 1. Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region) 2. History or current immunotherapy for any allergen (including food allergy, allergic rhinitis and or insect allergy) 3. Treatment ever with any monoclonal antibody or systemic biologic immunomodulatory therapy 4. Known hypersensitivity to any of the system components (except peanut), including the adhesive film, ever 5. Inability to discontinue short acting or long acting antihistamines for the minimum wash out periods prior to the SPT and FC 6. History of wheezing illnesses asthma bronchiolitis that fulfills any of the following criteria 6.1. Two or more systemic corticosteroid courses for wheezing bronchiolitis asthma ever 6.2. Intubation mechanical ventilation or intensive care admission beyond the neonatal period 7. Peanut allergic participants presenting with a medical history of severe anaphylaxis to peanut will be excluded from this study 7.1. Severe anaphylaxis is defined by severe hypoxia, persistent hypotension or more than 20% drop in blood pressure, neurological compromise, or cyanosis or SpO2 less than or equal to 92%, confusion, cardiovascular collapse, loss of consciousness, bradycardia, or cardiac arrest 8. In the subgroup of participants requiring a FC at entry 8.1. Severe reaction during the entry screening FC including need for intubation, hypotension persisting after epinephrine administration, or need for three doses or more of systemic epinephrine 8.2. Viral upper respiratory infection or gastroenteritis or any severe disease within 7 days prior to the FC 8.3. Hypersensitivity to any component of the food challenge 9. Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa, as well as hereditary or idiopathic angioedema 10. Use of systemic long acting corticosteroids within 3 months prior to Visit 1 and or use of systemic short acting corticosteroids within 4 weeks prior to Visit 1 11. Receiving beta blocking agents, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers or tricyclic antidepressant therapy 12. Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmia 13. Past or currently active diseases which, in the opinion of the investigator or the sponsor, could affect the participant’s participation or place the participant at increased risk, including but not limited to eosinophilic gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases such as hypertension, psychiatric illness or cardiac disease, or other disorders affecting the liver, gastrointestinal system, kidneys, cardiovascular system, pulmonary system or blood 14. Participants parents caregivers unable to follow the protocol requirements 15. Participants in any personal relationship or dependency with the sponsor, investigator or study staff 16. Current participation in another clinical trial, or participation in another clinical trial in the 3 months prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who are determined to have achieved ad lib consumption by the investigator measured using eDiary data at Month 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-Related Quality of Life measured using Food Allergy Quality of Life Questionnaire Parent Proxy Form 10 (FAQLQ-PF10); Food Allergy Quality of Life Questionnaire Parent Impact Form 10 (FAQLQ-PI10); Food Allergy Independent Measure – Parent Form (FAIM-PF) at baseline, month 36 and month 48;Caregiver treatment experience measured using THRIVE Caregiver questionnaire at month 36 and month 48;Food Challenge outcomes measured using peanut protein dose and dose limiting symptoms at month 36;Outcomes of the Food Challenge for Group 2 subset measured using peanut protein dose and dose limiting symptoms at month 48;Allergy markers measured using peanut-specific IgE and IgG4 at baseline, month 12, month 24, month 36 and month 48;Allergy markers measured using peanut-component-specific IgE and IgG4 at baseline, month 12, month 24, month 36 and month 48;Allergy markers measured using peanut SPT wheal diameter at baseline, month 12, month 24, month 36 and month 48;Allergy markers measured using skin prick titration testing at baseline, month 12, month 24, month 36 and month 48;Safety measured using Adverse events (AEs) and treatment-emergent AEs (TEAEs) by system organ class (SOC) and Preferred Term (PT) at at each visit;Safety measured using Serious adverse events (SAEs) by SOC and PT, and SAEs relatedness to treatment at at each visit;Safety measured using TEAEs leading to treatment discontinuation at at each visit;Safety measured using severity of local cutaneous DBV712 patch induced AEs as assessed by the Investigator at study visits at at each visit;Safety measured using Adverse Events of Special Interest (AESIs) including local and systemic AESIs (whatever the causal relationship to DBV712 250 µg) at at each visit;Safety measured using AEs associated with Accidental Peanut Consumption at at each visit;Safety measured using AEs associated with peanut consumption during the Peanut Consumption Period at at each visit;Safety measured using Atopic dermatitis severity (SCOR | — |
Countries
Australia, Canada, England, United Kingdom
Contacts
Public ContactDBV Technologies
Outcome results
None listed