EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX)
- Conditions
- Peanut allergyTherapeutic area: Diseases [C] - Immune System Diseases [C20]MedDRA version: 20.1Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 100000004870
- Registration Number
- EUCTR2018-003323-10-IE
- Lead Sponsor
- DBV TECHNOLOGIES S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Subjects will be enrolled into this study only if they meet all the following criteria:
1. Signed informed consent form (ICF) by the subject’s parent(s)/guardian(s). This consent should be signed after completion of Month 12 DBPCFC procedures in EPITOPE study, and before any procedure in EPOPEX study is started;
2. Subjects who completed the EPITOPE study, with a completed and documented DBPCFC at Month 12 (Visit 10 and Visit 11);
3. Parents/guardians and subjects willing to comply with all study requirements during the subject’s participation in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects will be enrolled into this study only if they meet none of the following criteria:
1. Subjects who developed a severe anaphylactic reaction (see APPENDIX 5) during the DBPCFC at Month 12 (Visit 10 or Visit 11) in the EPITOPE study requiring a tracheal intubation or leading to a cardiac arrest and/or to coma. Other cases of severe anaphylaxis will be considered eligible to participate in the EPOPEX study;
2. Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures;
3. Generalized dermatologic disease (e.g., active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin, especially on the back, with no intact zones to apply the patches;
4. Subjects who developed hypersensitivity to materials and/or excipients of the Viaskin® patch;
5. Subjects who developed hypersensitivity to excipients of the food challenge formula (other than peanut proteins) used in the EPITOPE study or confirmed allergy to apple;
6. Subjects who failed to complete the DBPCFC at Month 12 in the EPITOPE study due to any reason, including clear aversion to the food formula matrix;
7. Inability to discontinue short-acting antihistamines or long-acting antihistamines for the minimum wash-out periods required (depending on half-lives, as specified in APPENDIX 4) prior to the SPT or the DBPCFC;
8. Diagnosis of asthma that has evolved and now fulfills any of the criteria defined as follows:
- Uncontrolled asthma (as per Global Initiative for Asthma [GINA] 2018 guidelines (34); see APPENDIX 3);
- Asthma requiring controller treatment step 3 or higher (as per GINA 2018 guidelines (34): either moderate [double low dose] of inhaled corticosteroid [ICS], or association of ICS with leukotriene receptor antagonist [LTRA]; see APPENDIX 3);
- Prior intubation/mechanical ventilation for asthma in the past year.
Asthmatic subjects with the following treatment options are eligible:
- No controller treatment (GINA step 1);
- Controller treatment monotherapy (GINA step 2): daily or short-term course (intermittent) low dose ICS or LTRA.
9. 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 2018 guidelines (34)).
10. Past or current disease(s) which, in the opinion of the Investigator or the Sponsor, may affect the subject’s participation in this study, including but not limited to past or active eosinophilic gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (e.g., hypertension, psychiatric, cardiac), or other disorders (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders).
11. Any disease in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.
12. Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa as well as hereditary or idiopathic angioedema.
13. Subject receiving ß-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
14. Subject who rece
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method