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  • FDA lifts partial clinical hold on phase III VITES...

FDA lifts partial clinical hold on phase III VITESSE trial of Viaskin Peanut 250 microg patch for peanut allergy.- DBV Technologies

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Published:24th Dec 2022

DBV Technologies announced that the FDA has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase III clinical trial that will evaluate the modified Viaskin Peanut 250 microg patch (DBV712) in peanut-allergic children ages 4 to 7 years.

The updated protocol will be submitted to study sites for subsequent Institutional Review Boards (IRB)/Ethics Committees (EC) approval.

In the Partial Clinical Hold (PCH) letter, the FDA requested changes to certain elements of the VITESSE protocol with the intent for the trial to support a Biologics License Application (BLA). The FDA communication contained four protocol modifications: the redefinition of the minimal daily wear time, the addition of a statistical test for the patch adhesion assessment, the reclassification of certain adverse events (AEs) to adverse events of special interest (AESIs) and an increase in the number of trial participants on active treatment.

Key design elements of VITESSE such as inclusion criteria, primary efficacy endpoint, responder criteria, efficacy assessment methodology and safety endpoints were not impacted by the PCH letter and have not changed. Following receipt of the PCH letter, DBV and the FDA discussed how VITESSE protocol modifications could best support the Agency’s review of a potential BLA for Viaskin Peanut as a peanut allergy treatment. In lifting the PCH, the FDA confirmed DBV satisfactorily addressed all clinical hold issues identified in the PCH letter.

The FDA stated that DBV may proceed with VITESSE with the following changes included in the revised protocol: The updated VITESSE Instructions for Use (IFU) will direct caregivers to apply one patch at approximately the same time each day, following removal of the previous day’s patch. The updated IFU now outlines that Viaskin Peanut 250 µg 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 will be assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately, which aligns with existing regulatory requirements for patch-based therapies. In post-PCH discussions, DBV and the FDA agreed a statistical test of adhesion will be included in the VITESSE statistical analysis plan and further considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform. Four AEs will be classified as AESIs. These AEs – which include AEs leading to inhaled or systemic corticosteroid or epinephrine use, systemic allergic reactions, and Grade 4 local application site (skin) reactions – were collected and assessed in all previous Viaskin Peanut trials and included in the previous VITESSE protocol. Only the classification of these AEs has changed.

DBV plans to initiate a separate safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo. The additional safety data generated by this six-month study will supplement the safety data generated by the VITESSE trial, resulting in a safety database comprised of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut. The protocol design of the safety study will be submitted to the FDA and is expected to be similar to the REALISE (REAL Life Use and Safety of EPIT) safety study that DBV previously conducted with Viaskin Peanut in children ages 4 to 11 years.

Condition: Allergy/ Peanut
Type: drug

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