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ViaskinTM Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy (VITESSE)
EU CTIS ID: 2022-502110-85-00
What this study is testing
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.
- 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
- Children aged 4 through 7 years at Visit 1 (screening)
- Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reaction(s) after ingestion of peanut
- Currently following a strict peanut-free diet
- Access to emergency medications (including self-injectable epinephrine) and a current food allergy emergency action plan
- 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)
- Signed informed consent from a legally authorized representative and the signed assent of children 7 years of age (or as per country-specific regulations)
You likely can't join if
- Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region)
- 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)
- History of any immunotherapy for peanut allergy, including EPIT, OIT, SLIT
- 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
- Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa as well as hereditary or idiopathic angioedema
- 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
See the full eligibility criteria
Who can join
- Children aged 4 through 7 years at Visit 1 (screening)
- Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reaction(s) after ingestion of peanut
- Currently following a strict peanut-free diet
- Access to emergency medications (including self-injectable epinephrine) and a current food allergy emergency action plan
- 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)
- Signed informed consent from a legally authorized representative and the signed assent of children 7 years of age (or as per country-specific regulations)
- Subjects and parents/caregivers willing to comply with all study requirements during participation in the study
- An ED of ≤ 100 mg peanut protein at screening Double-blind, Placebo-controlled Food Challenge (DBPCFC)
What rules you out
- Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region)
- 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)
- History of any immunotherapy for peanut allergy, including EPIT, OIT, SLIT
- 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
- Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa as well as hereditary or idiopathic angioedema
- 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
- 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)
- Subjects with severe psychiatric, psychological or neurological disorders
- 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
- Subjects unable to follow the protocol requirements
- Current participation in another clinical trial, or participation in another clinical trial in the last 3 months prior to Visit 1
- Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy)
- 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
- Developing dose-limiting symptoms to the placebo part of the Screening DBPCFC
- Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1
- 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)
- Known hypersensitivity to any of the system components (except peanut), including the adhesive film or excipients
- 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
- 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
- Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensinreceptor blockers, calcium channel blockers or tricyclic antidepressant therapy
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- United States
- Australia
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 Canada; United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.