Viaskin® Milk

Cow’s milk protein allergy, or CMPA, is the first allergy that appears during early childhood.

CMPA is often missed in the primary care setting and can be a significant cause of infant distress when left undiagnosed.

Symptoms can include gastrointestinal problems including vomiting and diarrhea, skin rash, angioedema or rapid swelling of the skin, and anaphylaxis. The only option available for CMPA management is the avoidance of cow’s milk, which can lead to issues of dietary imbalance, failure to thrive and poor quality of life.

CMPA is the most common food allergy in infants and young children, affecting 2% to 3% of the general population. In approximately 80% of CMPA cases, the allergy to cow’s milk disappears after age 16. However, according to an expert panel convened by the AAAAI, approximately 35% of children with severe CMPA subsequently develop other food allergies or allergic respiratory diseases, such as asthma. 

Development program for Viaskin® Milk

Viaskin® Milk
  1. Phase I
  2. Phase II
  3. Phase III
Phase I/II trials

MILES Efficacy and Safety Phase I/II Trial

The MILES trial (Viaskin MILk Efficacy and Safety) is a multi-center, double-blind, placebo-controlled, randomized Phase I/II trial to study the safety and efficacy of Viaskin Milk in pediatric patient populations (age 2 to 17) suffering from IgE-mediated cow’s milk protein allergy, or CMPA, with elevated IgE levels related to cow’s milk protein.

Part A (Phase I) of the MILES trial has been completed.

Learn More:
Press Release (Part A Completion)
Press Release (Phase II Initiation)

Academic development program for Viaskin® Milk

Pilot clinical trial of Viaskin® Milk with Assistance Publique Hopitaux de Paris (AP-HP)

In 2005, DBV Technologies conducted a double-blind, placebo-controlled pilot clinical trial of Viaskin® Milk with AP-HP in patients with cow’s milk protein allergy, or CMPA.

In this clinical trial, children (age 3 months to 15 years) with high levels of specific IgE were unable to consume more than 10 mL of cow’s milk. 

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SMILEE Phase IIa Trial

SMILEE (Study of efficacy and safety of the Viaskin® MILk in Milk-Induced Eosinophilic Esophagitis) was a Phase IIA clinical trial assessing the safety and efficacy of Viaskin® Milk for the treatment of milk allergy-induced Eosinophilic Esophagitis (EoE) in children ages 4-17.

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