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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dbv Technologies

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

1 Dec 2025 → ongoing

Decision date (initial)

2025-10-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DBV Technologies S.A

External identifiers

EU CT number

2025-521697-34-00

ClinicalTrials.gov

NCT07003919

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

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

Secondary objectives 1

1. N/A

Conditions and MedDRA coding

Peanut allergy

Study design 2 periods

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001481-PIP01-13

Plan to share IPD

Yes

IPD plan description

Personal data will be processed within the clinical site. Personal data will also be analyzed and processed within Sponsor’s organization or by its subcontractors within and outside EU/EEA

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Subjects 1 through 3 years of age at Visit 1
2. 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. 3. Subject adheres to a strict peanut-free diet
4. 4. Access to emergency medications (including auto-injectable epinephrine) and a current food allergy emergency action plan
5. 5. Signed informed consent from a legally authorized representative
6. 6. Subjects and parents/caregivers willing to comply with all study requirements during participation in the study

Exclusion criteria 22

1. 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.
2. 2. Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region)
3. 3. Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy)
4. 4. History of any immunotherapy for peanut allergy, including EPIT, OIT, SLIT
5. 5. Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1
6. 6. Known hypersensitivity to any of the system components (except peanut), including the adhesive film
7. 7. Known hypersensitivity to any component of the food challenge formula (except peanut)
8. 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. 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
10. 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. 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. 12. Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa, as well as hereditary or idiopathic angioedema
13. 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. 14. Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy
15. 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. 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. 17. Subjects with severe psychiatric, psychological or neurological disorders
18. 18. Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias
19. 19. Subjects unable to follow the protocol requirements
20. 20. Current participation in another clinical trial, or participation in another clinical trial in the last 3 months prior to Visit 1
21. 21. Subjects in any personal relationship or dependency with the Sponsor and/or the Investigator or the study staff.
22. 22. Developing dose-limiting symptoms to the placebo part of the Screening DBPCFC

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 12

1. The following study drug safety criteria will be evaluated: • AEs and Treatment Emergent Adverse Events (TEAEs) by system organ class (SOC) and Preferred Term (PT)
2. TEAEs by maximum severity, duration, and relatedness to treatment
3. TEAEs leading to discontinuation
4. Severity of local cutaneous DBV712 system induced AEs as assessed by the Investigator at study visits
5. AESI including local and systemic AESIs
6. Local AESIs: severe local site reactions (grade 4 with loss of skin barrier integrity)
7. Systemic AESIs: systemic allergic reactions, including those leading to epinephrine use, whatever the causal relationship to DBV712 250 µg
8. AEs leading to epinephrine use, irrespective of the causal relationship to DBV712 250 µg
9. AEs leading to inhaled or systemic corticosteroid use, irrespective of the causal relationship to DBV712 250 µg
10. SAEs by SOC and PTs and SAEs relatedness to treatment
11. Laboratory data, physical examinations and vital signs
12. Assessment of pain and ease of removal of DBV712

Secondary endpoints 7

1. The following exploratory assessments will be evaluated: • Change from baseline in peanut-specific IgE and IgG4
2. Change from baseline in peanut-component-specific IgE and IgG4
3. Change from baseline in peanut SPT mean wheal diameters
4. Description of reactions triggered by peanut consumption during the study
5. SCORAD evolution over time
6. Assessment of system adhesion and average daily application time
7. Parent/caregiver daily assessment of Local Skin Reactions (itching, redness and swelling)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dbv Technologies

Sponsor organisation

Dbv Technologies

Address

107 Avenue De La Republique

City

Chatillon

Postcode

92320

Country

France

Scientific contact point

Organisation

Dbv Technologies

Contact name

Dr. Dianne Campbell, M.B.,B.S., PhD

Public contact point

Organisation

Dbv Technologies

Contact name

Dr. Dianne Campbell, M.B.,B.S., PhD

Third parties 4

Locations

4 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 46 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications