Can Peanut Allergy Be Changed in Infancy? DBV’s THRIVE Trial Tests a Bold New Approach

A potentially important shift is underway in food allergy research as investigators begin evaluating whether treating peanut allergy during infancy can fundamentally alter the trajectory of the disease. DBV Technologies recently screened the first participant in its Phase 2 THRIVE clinical trial, an open-label study testing the VIASKIN Peanut Patch in infants aged 6 to 12 months with confirmed peanut allergy. Douglas Mack, MD, a principal investigator in the trial, assistant clinical professor at McMaster University, and vice president of the Canadian Society of Allergy and Clinical Immunology, says the study is the first to evaluate epicutaneous immunotherapy (EPIT) in infants this young.

The scientific foundation for THRIVE builds upon landmark findings like the Learning Early About Peanut Allergy (LEAP) trial, which demonstrated that early allergen exposure reduces the risk of developing peanut allergy in high-risk infants. THRIVE takes the next logical step by investigating whether treatment after peanut allergy has already developed can influence the disease’s trajectory while the immune system remains especially adaptable during infancy. As Dr Mack noted, “The Thrive study is the first of its kind study looking at implementing immunotherapy with epicutaneous immunotherapy in infants ages 6 to 12 months of age.” He explained that because peanut allergy progresses early in life, “there may be a way that we can intervene early enough to try to influence the trajectory of the disease and manage the long-term complications of the disease.”

Under the study protocol, infants will wear the VIASKIN Peanut Patch daily for 36 months while remaining on a strict peanut-free diet. The noninvasive patch exposes the skin’s immune system to an amount of peanut protein equivalent to roughly one-thousandth of a peanut each day. Over the course of the three-year treatment period, that adds up to approximately the protein found in a single peanut. Based on previous studies in older children, investigators expect the most common side effects to be mild, localized skin irritation where the patch is applied, while THRIVE will formally evaluate the therapy’s safety in infants. Dr Mack noted that earlier studies in children ages 1 to 3 and 4 to 7 produced encouraging efficacy and safety findings, supporting the decision to evaluate the therapy in even younger infants.

Following the 36-month patch regimen, participants will undergo an oral food challenge to evaluate their level of immune desensitization and determine the trial’s fourth-year phase. Based on each child’s response and predefined study criteria, participants will either begin introducing peanut into their diet without continued patch therapy or continue using the patch while gradually introducing peanut during the study’s fourth year. Dr Mack emphasized that the three-year treatment duration was deliberately chosen based on broader allergy immunotherapy principles: “We know that for immunotherapy three years is probably a very good amount of time to try to really teach the body to teach it to learn this new language of tolerance, and I think that’s exactly what we’re trying to do.”

Unlike studies focused primarily on increasing the amount of peanut a patient can safely tolerate, THRIVE is designed to determine whether treatment begun during infancy can eventually support “ad lib” peanut consumption—allowing children to eat peanuts as part of a normal diet without following a rigid daily dosing schedule. Dr Mack explained that the study is designed to determine whether intervention during infancy can produce durable immune changes that more closely resemble long-term tolerance than temporary desensitization. “I think when we look at ad lib once again, that’s just like another child who is not necessarily peanut allergic,” he said. He added that “the goal of this is to try to induce a change, so that these patients can really function similarly to children that were never allergic to begin with,” potentially reducing the daily stress and burden that peanut allergy places on families.

Beyond individual clinical outcomes, the THRIVE trial could also have important implications for pediatric practice and clinical workflows. If early EPIT proves successful and ultimately becomes part of routine care, it could fundamentally reshape how primary care pediatricians manage early peanut introduction and allergic reactions. Dr Mack observed that “from a pediatrician’s perspective, what it’s going to do is prioritize how quickly we get these kids introduced to peanut in the first place.” If the approach proves successful and eventually becomes available, he envisions infants who experience allergic reactions during early peanut introduction being referred rapidly to allergists for evaluation and potential treatment rather than spending years simply avoiding peanuts, envisioning “a scenario where patients are rapidly sent to the allergist for rapid treatment right on the spot.”

Ultimately, the THRIVE trial represents an important milestone in pediatric allergy research, exploring whether a practical, family-friendly treatment begun during infancy can fundamentally change the course of peanut allergy. By treating peanut allergy before children even develop conscious awareness of their condition, researchers hope to redefine long-term disease management. Reflecting on the broader clinical significance of the study, Dr Mack concluded, “This is something that I think will change how we triage, change how we approach this, and lead to a prioritization of these kids. The data generated from THRIVE will be critical data in the youngest peanut allergy population ever to evaluate in a clinical trial of this size with epicutaneous immunotherapy. I think it’s very exciting.”

See Dr Mack’s video from Contemporary Pediatrics: