E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034202 |
E.1.2 | Term | Peanut allergy |
E.1.2 | System Organ Class | 100000004870 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety and tolerability of repeated application of “DBV712 Peanut allergy vaccine“ or “DBV712“ in adult, adolescent, and child subjects with a known allergy to peanut. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of DBV712 versus placebo by measuring the proportion of subjects who experienced and required a treatment for systemic reactions related to DBV712 or placebo and to evaluate the overall adherence to the study treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or Female age 6 to 50 years at enrollment Physician-diagnosed peanut allergy or convincing history of peanut allergy regardless of the degree of the reaction A positive skin prick test to peanut allergen with a wheal diameter >8 mm AND peanut-specific IgE measured by ImmunoCAP >5kU/L. Use of an effective method of contraception by females of childbearing potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. Women who have had a hysterectomy or tubal ligation at least 6 months prior to the screening visit or who have been post-menopausal for at least 1 year prior to the screening visit are not considered to be of childbearing potential. Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (1994). |
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E.4 | Principal exclusion criteria |
Participation in a study using an investigational new drug in the last 30 days prior to the screening visit. Participation in any interventional study for the treatment of food allergy in the past 6 months prior to the screening visit. Pregnancy or lactation. Allergy or known hypersensitivity to the Viaskin patch or adhesives. Severe or poorly controlled atopic dermatitis or generalized eczema. FEV1 value <80% predicted or any clinical features of moderate or severe persistent asthma at baseline and treated by doses greater than high daily doses of inhaled corticosteroids (as defined in dosing tables from the 2007 NHLBI guidelines). Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, or burst oral steroid course in the past 6 months, or >1 burst oral steroid course in the past year, prior to the screening visit. Use of oral steroids as described above after the screening visit and before randomization will render the subject non eligible for randomization. Asthma requiring 1 or more hospitalization(s) in the past year or >1 emergency department visit in the past 6 months, prior to the screening visit. Occurrence of asthma in these conditions after the screening visit and before randomization will render the subject non eligible for randomization. Use of omalizumab or immunomodulatory or biologic therapy in the past year prior to the screening visit. Use of nontraditional forms of allergen immunotherapy (such as oral immunotherapy or sublingual immunotherapy) in the past year prior to the screening visit. Use of subcutaneous immunotherapy other than a stable maintenance dose for less than a year prior to the screening visit. Use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers. Inability to discontinue antihistamines for at least 1 week to allow skin testing at the screening visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is safety and the subjects will undergo the following procedures: physical examination including patch application site examination for evaluation of any skin reaction, vital signs, blood and urine collection for blood and urine analysis, ECG, Peak Expiratory Flow and spirometry (FEV1).
Adverse events, treatment-emergent adverse events, and serious adverse events will be classified according to severity, treatment relatedness, the system/organ class affected, and the countermeasures taken.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment. |
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E.5.2 | Secondary end point(s) |
The proportion of subjects that experience systemic reactions such as urticaria, asthma and acute dyspnea, change in blood pressure, and digestive symptoms (vomiting, diarrhea) associated with experimental treatment versus placebo. The proportion of subjects requiring treatment for systemic reactions related to experimental treatment or placebo. Overall adherence to the study treatment
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |