A phase 2, open label study to assess ad lib consumption of peanut in peanut allergic infants 6-through 12-months-old with epicutaneous immunotherapy with DBV712 250 µg (THRIVE)
Treatment of patients diagnosed with peanut allergy
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 µg cutaneous patch Period #2: Peanut consumption period (for eligible participants): DBV712 250 µg, or no treatment The study includes a Peanut Consumption Period with or without continuation of treatment with DBV712 250 µg for eligible participants where participants will be divided into 3 groups based on the results of the Month 36-food challenge: Participants who consume the entire FC (maximum cumulative dose: 4998 mg peanut protein) without dose limiting symptoms (DLS) will be in Group 1; 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 Consumption Period and Discontinuation of DBV712 250 µg cutaneous patch Group 2: Peanut Consumption Period and Continuation of DBV712 250 µg cutaneous patch Group 3: No Peanut Consumption Period and Discontinuation of DBV712 250 µg cutaneous patch. Group 3 will continue to be followed. For group 2, DBV712 250 µg cutaneous patch regimen and route of administration are unchanged. Treatment duration: 12 months (+ 2 weeks safety follow-up) Assigned intervention #2: For Group 2, DBV712 250 µg cutaneous patch
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
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 V