A clinical study to assess DBV1605 for the diagnosis of cow's milk allergy in children.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

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 <3 mm and negative control <1 mm.

CONTROL GROUP
Subjects may be included in the control group only if they meet, among other criteria, the following inclusion criteria:
• Male or female subjects aged >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 <3 mm and negative control <1 mm.
Are the trial subjects under 18? yes
Number of subjects for this age range: 230
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

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.

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

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