ARACHIS HYPOGAEA EXTRACT for Peanut allergy

Inclusion criteria

• {"criterion_text":"- 1.\tSubjects 1 through 3 years of age at Visit 1\n- 2.\tPhysician-diagnosed peanut allergy or high suspicion of peanut allergy as assessed by the physician AND a.\tPeanut specific IgE (ImmunoCAP system) > 0.7 kUA/L at Screening; AND b.\tPositive peanut SPT with a largest wheal diameter ≥ 6 mm at Screening; AND c.\tPositive DBPCFC to peanut, with symptoms meeting the challenge stopping criteria at an ED ≤ 300 mg peanut protein.\n- 3.\tSubject adheres to a strict peanut-free diet\n- 4.\tAccess to emergency medications (including auto-injectable epinephrine) and a current food allergy emergency action plan\n- 5.\tSigned informed consent from a legally authorized representative\n- 6.\tSubjects and parents/caregivers willing to comply with all study requirements during participation in the study"}

Exclusion criteria

• {"criterion_text":"- 1.\tPeanut allergic subjects presenting a medical history of severe anaphylaxis to peanut will be excluded from this study. Severe anaphylaxis is defined by severe hypoxia, persistent hypotension or more than 20% drop in blood pressure, neurological compromise, or cyanosis or SpO2 ≤ 92% at any stage, confusion, cardiovascular collapse, loss of consciousness, bradycardia, cardiac arrest.\n- 10.\tUse 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 (see Section 8.2.2 and APPENDIX 3)\n- 11.\tUse of cyclosporine or other immunosuppressive agents within 6 months prior to Visit 1, or during the screening period or during study participation. Topical calcineurin inhibitors are permitted\n- 12.\tDiagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa, as well as hereditary or idiopathic angioedema\n- 13.\tGeneralized dermatologic/infectious disease (for example active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris, varicella zoster, etc.) extending widely on the skin and especially on the back with no intact zones to apply the system\n- 14.\tReceiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy\n- 15.\tReceived anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy within 6 months prior to Visit 1, or planned use during study participation\n- 16.\tPast or currently active disease(s) which, in the opinion of the Investigator or the Sponsor, could affect the subject’s participation in this study or place the subject at increased risk during participation in the study, including but not limited to eosinophilic gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (e.g., hypertension, psychiatric illness, cardiac disease), or other disorders (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders)\n- 17.\tSubjects with severe psychiatric, psychological or neurological disorders\n- 18.\tAny disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias\n- 19.\tSubjects unable to follow the protocol requirements\n- 2.\tSevere generalized dermatologic disease involving the proposed treatment application area (interscapular region)\n- 20.\tCurrent participation in another clinical trial, or participation in another clinical trial in the last 3 months prior to Visit 1\n- 21.\tSubjects in any personal relationship or dependency with the Sponsor and/or the Investigator or the study staff.\n- 22.\tDeveloping dose-limiting symptoms to the placebo part of the Screening DBPCFC\n- 3.\tCurrent immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy)\n- 4.\tHistory of any immunotherapy for peanut allergy, including EPIT, OIT, SLIT\n- 5.\tTreatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1\n- 6.\tKnown hypersensitivity to any of the system components (except peanut), including the adhesive film\n- 7.\tKnown hypersensitivity to any component of the food challenge formula (except peanut)\n- 8.\tInability to discontinue short-acting or long-acting antihistamines for the minimum wash-out periods prior to the SPT as specified in APPENDIX 2\n- 9.\tDiagnosis of asthma that fulfills any of the following criteria: a.\tUncontrolled persistent asthma as defined by the Global Initiative for Asthma [GINA] guidelines (GINA 2022) b.\tPresence of more than 3 episodes of wheezing in the past year (each lasting more than 10 consecutive days, apart from colds) or presence of respiratory symptoms (wheezing, cough, heavy breathing) between these episodes, and/or other respiratory symptoms suggesting either undiagnosed asthma or asthma not controlled by asthma treatment (as per GINA guidelines) c.\tTwo or more systemic corticosteroid courses for asthma in the past year or 1 oral corticosteroid course for asthma within 3 months prior to Visit 1 d.\tIntubation/mechanical ventilation or intensive care admission for asthma within 1 year prior to Visit 1"}

Primary endpoints

• {"endpoint_text":"- The following study drug safety criteria will be evaluated: •\tAEs and Treatment Emergent Adverse Events (TEAEs) by system organ class (SOC) and Preferred Term (PT)\n- TEAEs by maximum severity, duration, and relatedness to treatment\n- TEAEs leading to discontinuation\n- Severity of local cutaneous DBV712 system induced AEs as assessed by the Investigator at study visits\n- AESI including local and systemic AESIs\n- Local AESIs: severe local site reactions (grade 4 with loss of skin barrier integrity)\n- Systemic AESIs: systemic allergic reactions, including those leading to epinephrine use, whatever the causal relationship to DBV712 250 µg\n- AEs leading to epinephrine use, irrespective of the causal relationship to DBV712 250 µg\n- AEs leading to inhaled or systemic corticosteroid use, irrespective of the causal relationship to DBV712 250 µg\n- SAEs by SOC and PTs and SAEs relatedness to treatment\n- Laboratory data, physical examinations and vital signs\n- Assessment of pain and ease of removal of DBV712","definition_or_measurement_approach":"- AEs and TEAEs will be captured and analysed by SOC and PT.\n- TEAEs will be summarised by maximum severity, duration and investigator-assessed relatedness to treatment.\n- TEAEs leading to discontinuation will be recorded and reported.\n- Local cutaneous AEs will be graded by Investigator at study visits (severity assessment).\n- AESIs include predefined local and systemic events; local AESIs specifically include severe local site reactions defined as grade 4 with loss of skin barrier integrity.\n- Systemic AESIs include systemic allergic reactions including those resulting in epinephrine use regardless of causal attribution to DBV712 250 µg.\n- Events leading to epinephrine use or corticosteroid use will be recorded irrespective of causal relationship.\n- SAEs will be reported and categorised by SOC and PT with assessment of relatedness to treatment.\n- Routine laboratory tests, physical exams and vital signs will be collected per schedule of assessments.\n- Pain and ease of removal of the DBV712 system will be assessed (investigator/parent/caregiver assessments as per schedule)."}

Secondary endpoints

• {"endpoint_text":"- The following exploratory assessments will be evaluated: •\tChange from baseline in peanut-specific IgE and IgG4\n- Change from baseline in peanut-component-specific IgE and IgG4\n- Change from baseline in peanut SPT mean wheal diameters\n- Description of reactions triggered by peanut consumption during the study\n- SCORAD evolution over time\n- Assessment of system adhesion and average daily application time\n- Parent/caregiver daily assessment of Local Skin Reactions (itching, redness and swelling)","definition_or_measurement_approach":"- Change from baseline in peanut-specific IgE and IgG4 will be measured using immunoassays (e.g., ImmunoCAP) per schedule.\n- Component-resolved peanut-specific IgE/IgG4 changes measured similarly.\n- Peanut SPT mean wheal diameters measured and compared to baseline.\n- Reactions to peanut consumption described and recorded during study visits and as reported.\n- SCORAD (atopic dermatitis score) tracked over time per schedule.\n- System adhesion and average daily application time recorded (device adherence assessments).\n- Parents/caregivers will complete daily assessments (eDiary) of local skin reactions (itching, redness, swelling)."}

Methods

• Country-specific recruitment materials: patient letters (patient-facing) for Ireland/Netherlands/France/Spain aimed at parents/caregivers of 1–3 year-old children with peanut allergy.
• Brochures and posters (printed) for site distribution (country-specific; Dutch materials for Netherlands, French materials for France, Spanish materials for Spain).
• Website design and online auto-recruitment materials (country-specific) as documented for France and Spain (online outreach).
• Recruitment procedures documented (K1 recruitment procedure) for participating countries to guide site-level recruitment and screening.

Spain

Earliest CTIS Part Ii Submission Date

28-07-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

84

Number Of Sites

5

Number Of Participants

15

France

Earliest CTIS Part Ii Submission Date

30-09-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

20

Number Of Sites

6

Number Of Participants

14

Netherlands

Earliest CTIS Part Ii Submission Date

02-10-2025

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

27

Number Of Sites

2

Number Of Participants

8

Ireland

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

31-10-2025

Processing Time Days

46

Number Of Sites

2

Number Of Participants

17

Primary sponsor

Full Name

Dbv Technologies

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Operational CRO responsibilities as listed in sponsor duties (codes: 1, 12, 2, 3, 5, 7, 8)

Third parties

• {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"Drug labeling, QP release (codes: 14, 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Laboratory (code 15); other code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO responsibilities (codes: 1, 12, 2, 3, 5, 7, 8)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA system app (MyMedidata) – endpoint data, Device Provisioning and Delivery to sites for caregiver use","organisation_type":"Non-Pharmaceutical company"}