Partial clinical hold on peanut allergy treatment study is lifted 

DBV Technologies has announced that the Food and Drug Administration (FDA) has lifted the partial clinical hold on the company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 clinical trial. A “partial clinical hold” is a delay or a suspension of part of a clinic study. 

 Viaskin is a skin patch for peanut allergy which aims to desensitise individuals by introducing very small amounts of peanut via the skin. The FDA previously had concerns about Viaskin patch’s adhesion to the skin and the impact of that on treatment. 

The VITESSE trial will now evaluate a modified Viaskin™ Peanut patch in peanut-allergic children ages 4 to 7 years. The new patch is 50% bigger and circular in shape. There are also a number of other changes included in the revised study protocol: 

• Updated instructions that Viaskin Peanut patch is to be worn for as close to a full day as possible (i.e., 24 hours) with a minimum daily wear time of 20 hours each day. 

• Patch adhesion (stickiness) will be assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately. Some of the adverse events (undesired effects such as allergic reactions or skin rashes) will be classified differently. There will be an additional separate safety study in approximately 275 participants, to generate additional safety data.  

DBV plans to start recruiting for the VITESSE trial in the first quarter of 2023 and have the first results ready to share in 2025. 

Simon Williams, Chief Executive of Anaphylaxis UK said:

“This is encouraging news for people with an allergy and takes us another step closer to a new treatment option.”

You can read the full press release here.