Authorised Therapeutic confirmatory (Phase III) Peanut allergy

A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy with DBV712 250 µg in 1-through 3-year-old Children with Peanut Allergy (COMFORT Toddlers)

EU CTIS ID: 2025-521697-34-00

What this study is testing

To assess the 6-month safety of DBV712 250 µg in subjects 1 through 3 years of age with peanut allergy

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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

You likely can't join if

1. Peanut 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.
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 (see Section 8.2.2 and APPENDIX 3)
11. Use 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
12. Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa, as well as hereditary or idiopathic angioedema
13. Generalized 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
14. Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy

See the full eligibility criteria

Who can join

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

What rules you out

1. Peanut 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.
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 (see Section 8.2.2 and APPENDIX 3)
11. Use 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
12. Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa, as well as hereditary or idiopathic angioedema
13. Generalized 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
14. Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy
15. Received 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
16. Past 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)
17. Subjects with severe psychiatric, psychological or neurological disorders
18. Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias
19. Subjects unable to follow the protocol requirements
2. Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region)
20. Current participation in another clinical trial, or participation in another clinical trial in the last 3 months prior to Visit 1
21. Subjects in any personal relationship or dependency with the Sponsor and/or the Investigator or the study staff.
22. Developing dose-limiting symptoms to the placebo part of the Screening DBPCFC
3. Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy)
4. History of any immunotherapy for peanut allergy, including EPIT, OIT, SLIT
5. Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1
6. Known hypersensitivity to any of the system components (except peanut), including the adhesive film
7. Known hypersensitivity to any component of the food challenge formula (except peanut)
8. Inability to discontinue short-acting or long-acting antihistamines for the minimum wash-out periods prior to the SPT as specified in APPENDIX 2
9. Diagnosis of asthma that fulfills any of the following criteria: a. Uncontrolled persistent asthma as defined by the Global Initiative for Asthma [GINA] guidelines (GINA 2022) b. Presence 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. Two 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. Intubation/mechanical ventilation or intensive care admission for asthma within 1 year prior to Visit 1

The study team makes the final eligibility decision.

Where it's taking place

United States
Australia
United Kingdom
Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Australia; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.