ViaskinTM Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy (VITESSE)

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

18 Jan 2024 → ongoing

Decision date (initial)

2023-07-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DBV Technologies S.A.

External identifiers

EU CT number

2022-502110-85-00

ClinicalTrials.gov

NCT05741476

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

To assess the efficacy and safety of DBV712 250 μg to induce desensitization to peanut in peanut-allergic children 4-7 years of age over the 12-month DBPC Treatment Period.

Secondary objectives 1

1. To evaluate the magnitude of effect of DBV712 250 μg to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month Treatment Period.

Conditions and MedDRA coding

Peanut allergy

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Children aged 4 through 7 years at Visit 1 (screening)
2. Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reaction(s) after ingestion of peanut
3. Currently following a strict peanut-free diet
4. Access to emergency medications (including self-injectable epinephrine) and a current food allergy emergency action plan
5. Documentation of serum peanut-specific IgE of > 0.7 kUA/L (ImmunoCAP system) AND positive peanut SPT with the largest wheal diameter of ≥ 6 mm within the past 6 months (including during screening)
6. Signed informed consent from a legally authorized representative and the signed assent of children 7 years of age (or as per country-specific regulations)
7. Subjects and parents/caregivers willing to comply with all study requirements during participation in the study
8. An ED of ≤ 100 mg peanut protein at screening Double-blind, Placebo-controlled Food Challenge (DBPCFC)

Exclusion criteria 21

1. Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region)
2. Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy)
3. Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1
4. Past history of severe anaphylaxis to peanut (defined as respiratory compromise requiring mechanical support (continuous positive airway pressure [CPAP] or intubation and ventilation), reduced blood pressure (BP) with associated symptoms of end-organ dysfunction (e.g., hypotonia, collapse, syncope) OR > 30% decrease in systolic BP from baseline)
5. Known hypersensitivity to any of the system components (except peanut), including the adhesive film or excipients
6. Inability to discontinue short-acting or long-acting antihistamines for the minimum washout periods prior to the SPT and DBPCFC as specified in APPENDIX 4 of the protocol
7. Diagnosis of asthma that fulfills any of the following criteria: a. Uncontrolled persistent asthma as defined by the Global Initiative for Asthma (GINA) guidelines 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
8. Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensinreceptor blockers, calcium channel blockers or tricyclic antidepressant therapy
9. 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
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 6.2.2 and APPENDIX 5 of the protocol)
11. History of any immunotherapy for peanut allergy, including EPIT, OIT, SLIT
12. 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
13. Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa as well as hereditary or idiopathic angioedema
14. 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
15. 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)
16. Subjects with severe psychiatric, psychological or neurological disorders
17. Concomitant medical conditions that increase life threatening risk in the event of a severe allergic reaction including severe cystic fibrosis, lung fibrosis, pulmonary hypertension, unstable angina, recent myocardial infarction or significant arrhythmia or any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias
18. Subjects unable to follow the protocol requirements
19. Current participation in another clinical trial, or participation in another clinical trial in the last 3 months prior to Visit 1
20. Subjects in any personal relationship or dependency with the Sponsor and/or the Investigator or the study staff. Family members of the Sponsor, the Investigator or the study staff could not be part of the study
21. Developing dose-limiting symptoms to the placebo part of the Screening DBPCFC

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Primary endpoints: Percentage of treatment responders in the DBV712 250 μg group compared to the placebo group after 12 months of treatment in the target population. A subject is defined as a treatment responder if: - The initial ED was ≤ 30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR
2. - The initial ED was > 30 mg peanut protein and the ED is ≥ 600 mg peanut protein at the post-treatment DBPCFC at Month 12
3. Safety: The following safety criteria will be evaluated: - Adverse events and treatment-emergent AEs (TEAEs) - Assessment of pain and ease of removal of DBV712 - AESIs defined as: o Local AESIs: severe local site reactions (grade 4 with loss of skin barrier integrity)
4. o Systemic AESIs: systemic allergic reactions, including those leading to epinephrine use, whatever the causal relationship to DBV712 250 μg o AEs leading to epinephrine use, irrespective of the causal relationship to DBV712 250 μg o AEs leading to inhaled or systemic corticosteroid use, irrespective of the causal relationship to DBV712 250 μg
5. - Systemic allergic reactions (Graded by CoFAR Grading Scale for Systemic Allergic Reactions V3.0 [APPENDIX 2]) - AE leading to topical corticosteroids use - Serious adverse events (SAEs) - Physical examinations (including grading any inflammation at system sites), SCORAD and vital signs

Secondary endpoints 4

1. CRD of peanut protein after 12 months of treatment in the DBV712 250 μg group versus the placebo group. CRD will also be presented in each of the 2 screening ED subgroups;
2. ED of peanut protein after 12 months of treatment in the DBV712 250 μg group versus the placebo group. ED will also be presented in each of the 2 screening ED subgroups;
3. Percentage of subjects with an ED ≥ 600 mg and the percentage of subjects with an ED ≥ 1000 mg peanut protein at Month 12 in the DBV712 250 μg group versus the placebo group, overall, and in each of the 2 screening ED subgroups;
4. Maximum severity of allergic reaction at baseline and Month 12 Food Challenge in the DBV712 250 μg group versus the placebo group.

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

Batiment Iro, 107 Avenue De La Republique 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 6

Locations

5 EU/EEA countries · 17 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 191 files

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

Application history

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