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Epitope open-label extension study to evaluate the long-term clinical benefit and safety of DBV712 in peanut-allergic children (EPOPEX)
EU CTIS ID: 2024-515703-19-00
What this study is testing
To assess the clinical benefit of Viaskin Peanut after up to 3 years of epicutaneous immunotherapy (EPIT) to induce/maintain desensitization to peanut in peanut-allergic children; To evaluate the safety of long-term treatment with Viaskin Peanut in peanut-allergic children.
- 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
- 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;
- Subjects who completed the EPITOPE study, with a completed and documented DBPCFC at Month 12 (Visit 10 and Visit 11)
- Parents/guardians and subjects willing to comply with all study requirements during the subject's participation in the study.
You likely can't join if
- 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;
- 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).
- Any disease in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.
- Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa as well as hereditary or idiopathic angioedema.
- Subject receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
- Subject who received in the past year or planning to receive antitumor necrosis factor drugs or anti-IgE drugs (e.g., omalizumab) any biologic immunomodulatory therapy, cyclosporine or other immunosuppressive drugs within. Topical calcineurin inhibitors are permitted.
See the full eligibility criteria
Who can join
- 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;
- Subjects who completed the EPITOPE study, with a completed and documented DBPCFC at Month 12 (Visit 10 and Visit 11)
- Parents/guardians and subjects willing to comply with all study requirements during the subject's participation in the study.
What rules you out
- 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;
- 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).
- Any disease in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.
- Diagnosis of mast cell disorders including mastocytosis or urticaria pigmentosa as well as hereditary or idiopathic angioedema.
- Subject receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
- Subject who received in the past year or planning to receive antitumor necrosis factor drugs or anti-IgE drugs (e.g., omalizumab) any biologic immunomodulatory therapy, cyclosporine or other immunosuppressive drugs within. Topical calcineurin inhibitors are permitted.
- Subject receiving or planning to receive any other type of immunotherapy to any food (e.g., oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) or any aeroallergen or venom immunotherapy during their participation in the study.
- Subjects or parent(s)/guardian(s) with obvious excessive anxiety and unlikely to cope with the food challenge procedures or unable to follow the protocol requirements.
- A history of high non-compliance during the EPITOPE study (i.e., subjects not applying the patches for 60 or more days in total and not applying the patches 30 or more consecutive days during the EPITOPE study) or subjects unable to perform the DBPCFC.
- Current participation in another clinical study, other than the EPITOPE study.
- Subjects being in any personal relationship or dependency with the Sponsor and/or the Investigator or the study staff.
- Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures;
- 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;
- Subjects who developed hypersensitivity to materials and/or excipients of the Viaskin™ patch;
- 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;
- 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;
- 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;
- 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.
- 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)).
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- 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 Australia; United States; United Kingdom; Canada. 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.