CTIS2022-502110-85-00招募中1 期
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy with DBV712 250 µg in 4-7-year-old Children with Peanut Allergy (VITESSE) - V712-306
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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 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
研究者
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