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

Phase 1

• Conditions: on-Immunoglobulin E Mediated Cow's Milk Allergy; MedDRA version: 20.0Level: LLTClassification code 10011240Term: Cow's milk allergySystem Organ Class: 100000004870; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-004523-21-IT
• Lead Sponsor: DBV Technologies S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

- Male or female subjects aged 1 month to 5 years at Screening Visit,
• 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 regular cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) within 1 month prior to Screening Visit,
• Subjects with a negative cow's milk SPT: mean wheal diameter <3 mm and negative control <1 mm.
Subjects may be included in the disease group if they do not meet, among other criteria, any of the following exclusion criteria:
• Subjects with an established diagnosis of non-IgE mediated by a physician after appropriate diagnostic testing including cow's milk
protein challenge,
• Breast-fed subject at Screening Visit,
• Subjects with a history of confirmed food protein-induced enterocolitis syndrome,
• Subjects with a convincing history of IgE-mediated CMA.
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 1 month to 5 years at 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 1 month prior to Visit 1.
• Subjects with negative cow's milk SPT: mean wheal diameter <3 mm and negative control <1 mm.
Subjects may be included in the control group if they do not meet, among other criteria, any of the following exclusion criteria:
• Subjects with history of persistent gastro-intestinal symptoms including vomiting, diarrhea, distress/colic, regurgitation, constipation, blood in stool, for at least 4 consecutive weeks within the previous year.
• Breast-fed subjects at Visit 1.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

DISEASE GROUP
1 Subjects with an established diagnosis of non-IgE mediated CMA made by a physician after appropriate diagnostic testing including 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 within 1 month of
Screening Visit.
4 Subjects with a history of confirmed FPIES.
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.
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 Intake of leukotriene receptor antagonists or 5-lipooxygenase inhibitors within 30 days prior to Screening Visit.
18 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.
19 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