Non-Immunoglobulin E Mediated Cow’s Milk Allergy MedDRA version: 20.0 Level: LLT Classification code 10011240 Term: Cow's milk allergy System Organ Class: 100000004870
Conditions
Interventions
Product Code: DBV1605 active and control patch
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: Milk allergen extract
Other descriptive name: COW MILK EXTRACT
Concentration unit: µg microgram
Sponsors
DBV Technologies S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: DISEASE GROUP • Male or female subjects aged >6 months to =24 months at Screening Visit. Age from >28 days to =24 months at Screening Visit after Safety Review Committee (SRC) recommendations are given. • Subjects with a history of symptoms that are consistent with non-IgE mediated CMA as per Investigator's assessment, by either: o Two or more gastrointestinal symptoms (vomiting, diarrhea, persistent distress/colic, regurgitation, constipation), that lasted at least 1 week within 1 month prior to Screening Visit o Blood in stool, • Subjects with any type of diet containing dairy products with cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) prior Screening Visit or who have started a cow's milk elimination diet not more than 4 weeks prior to Screening Visit. • Subjects with a negative cow's milk SPT: mean wheal diameter 28 days to =24 months at Screening/Visit 1, • Subjects having no medical history of any type of allergy, including no history of IgE-mediated allergic reactions to cow's milk and with no medical history of any food allergy in their family (parents, sibling), • Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 4 weeks prior to Screening/Visit 1. • Subjects with negative cow's milk SPT: mean wheal diameter =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: criteria is within the study protocol) DISEASE GROUP 1 Subjects with an established diagnosis of non-IgE mediated CMA made by a physician upon cow's milk protein challenge. 2 Breast-fed subjects at Screening Visit. 3 Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula initiated more than 4 weeks prior to Screening Visit. 4 Subjects with a history of confirmed FPIES or Heiner's syndrome. 5 Any contraindication to a cow's milk challenge, in particular subjects with a history of severe anaphylactic reaction to cow's milk. Severe anaphylaxis is defined as Grade 3 of the Anaphylaxis Staging System, including: • Severe hypoxia, persistent hypotension or more than 20% drop in blood pressure, neurological compromise, or • Cyanosis or SpO2 = 92% at any stage, confusion, cardiovascular collapse, loss of consciousness, bradycardia, cardiac arrest. 6 Subjects with a convincing history of IgE-mediated CMA. 8 Subjects with diagnosis of asthma or recurrent wheezing that fulfills any of the following criteria: - Uncontrolled asthma or recurrent wheezing (as per Global Initiative for Asthma (GINA) guidelines). - Asthma or recurrent wheezing that is considered uncontrolled per GINA guidelines or has had modifications in their asthma or wheezing controller medication within 3 months prior Screening Visit. 10 Known hypersensitivity to any of the DBV1605 components (except to milk proteins). 11 Known hypersensitivity to any component of the food challenge formula (except to milk proteins). 12 A history of any immunotherapy for CMA. 15 Any disorder in which epinephrine is contraindicated such as congenital cardiac malformation, uncontrolled hypertension, or serious ventricular arrhythmias. 17 Treatment with antihistamines within 1 to 7 days (depending on halflife and specified in APPENDIX 3) prior to Screening Visit or inability to discontinue antihistamines for the minimum wash-out periods required prior to SPT or food challenges. 18 Treatment with topical steroid applied on the back within 30 days prior to Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the diagnostic performance of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow’s milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA based on the sensitivity and the specificity.;Secondary Objective: The secondary objectives of the study are to: • Estimate the specificity of DBV1605 in a control group of subjects; • Assess the diagnostic performance of DBV1605 in different subgroups of interest; • Assess the adhesion and application duration of the DBV1605 patch; • Assess the safety of a single 48-hour application of DBV1605.;Primary end point(s): The sensitivity and the specificity of DBV1605 based on skin reactivity readings after 48 hours and 72 hours will be compared to the results of the DBPCFC in subjects of the disease group.;Timepoint(s) of evaluation of this end point: The DBV1605 patch test will be considered positive if, after 48 hours and/or 72 hours following application: • The skin reactivity under the control patch is rated Grades 0 or 1, and • The skin reactivity under the active patch is rated at least 1 grade higher than the control patch. The DBV1605 patch test will be considered negative if after both 48 hours and 72 hours: • The skin reactivity under the control patch is rated Grades 0 or 1, and • The skin reactivity under the active patch is rated the same grade as the control patch or 1 grade lower than the control patch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In the disease group of subjects: • DBV1605 sensitivity and specificity after readings at 48 hours; • DBV1605 sensitivity and specificity after readings at 72 hours; • DBV1605 sensitivity and specificity considering the test positive if, after 48 hours and/or 72 hours following application: o The skin reactivity under the control patch is rated Grades 0 or 1, and o The skin reactivity under the active patch is rated at least 2 grades higher than the control patch. In addition, other indicators of DBV1605 diagnostic performance could be explored, and subgroups could be considered for the analysis. The following secondary analyses will be conducted in the control group to confirm the results observed in the disease group: • DBV1605 specificity after readings at 48 hours and 72 hours in the control group. The adhesion of DBV1605 will be assessed with: • The proportions of patches with adhesion scored Grade 0 or 1 and the proportions of patches with adhesion scored higher than 1 at application; • The proportions of patches with adhesion scored Grade 0 or 1 and the proportions of patches with adhesion scored higher than 1 at removal. The duration of DBV1605 application will be assessed with: • The proportions of patches without detachment of the occlusive chamber as assessed by the parents/guardians at different timepoints: 24 hours ±1 hour, 36 hours ±1 hour and 48 hours ±1 hour; • The proportions of patches present at the application site more than 36 hours after application, excluding voluntary removal; • The mean duration of patch application until removal or detachment.;Timepoint(s) of evaluation of this end point: DBV1605 sensitivity and specificity readings at after 48 hours and 72 hours. The test will be considered positive if, after 48 hours and/or 72 hours following application: o The skin reactivity under the control patch is rated Grades 0 or 1, and o The skin reactivity under the active patch is rated at least 2 grades higher than the | — |
Countries
Canada, Italy, Lithuania, United States
Contacts
Public ContactDBV Technologies S.A.
DBV Technologies S.A.
Outcome results
None listed