
Douglas Mack, MD, says THRIVE study could change early peanut allergy management
Key Takeaways
- THRIVE is the first phase 2 study to evaluate the VIASKIN Peanut Patch in infants aged 6 to 12 months with peanut allergy.
- Investigators will assess whether early epicutaneous immunotherapy can enable ad lib peanut consumption after treatment.
The first infant has been screened in the THRIVE trial evaluating the VIASKIN Peanut Patch as an early intervention for peanut allergy.
DBV Technologies has announced that the first participant has been screened in the phase 2 THRIVE clinical trial, marking the start of a study evaluating the efficacy and safety of the VIASKIN Peanut Patch in infants aged 6 to 12 months with peanut allergy. The study is designed to determine whether early treatment can help children ultimately achieve ad lib peanut consumption, an approach investigators believe may capitalize on a period of heightened immune plasticity in infancy.
THRIVE is a single-arm, open-label study in which participants will wear the VIASKIN Peanut Patch daily for 36 months while maintaining a peanut-free diet. At the conclusion of the treatment period, participants will undergo an oral food challenge to determine whether they can transition to dietary peanut consumption with or without continued patch therapy during the study's fourth year.
According to Douglas Mack, MD, assistant clinical professor in the Department of Pediatrics at McMaster University, principal investigator for THRIVE, and vice president of the Canadian Society of Allergy and Clinical Immunology, the trial is focused on more than simply increasing peanut tolerance.
"I think the primary goal is to try to measure ad lib peanut consumption," Mack said. "I think when we look at ad lib once again, that's just like another child who is not necessarily peanut allergic."
Mack explained that achieving ad lib consumption would allow children to eat peanut when they choose rather than following a structured dosing schedule.
"So I think what it's going to do is ideally take the pressure off both the child and the parents, and allow this child to function before they're even conscious that they have a peanut allergy, really, as somebody who may not even have it anymore," he said. "And I think that's really 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."\
Why are investigators studying infants with peanut allergy?
The study builds on previous clinical trials evaluating the VIASKIN Peanut Patch in toddlers and older children. According to the company, earlier studies demonstrated encouraging results in children aged 1 through 3 years and 4 through 7 years, prompting expansion into infants.
Mack said younger children have consistently demonstrated more favorable responses to immunotherapy.
"What we've seen is that the younger children tend to do better with the patch, just like in other forms of immunotherapy, but we also find that the safety signal is quite favorable in these young kids," he said.
The patch delivers approximately one one-thousandth of a peanut through the skin each day. Over the full 3-year treatment period, Mack noted that participants receive the equivalent of approximately one peanut in total.
"We expect to see primarily that kind of local site irritation in most of these patients," he said, adding that the treatment does not involve oral peanut ingestion during therapy.
How could THRIVE affect pediatric practice?
Investigators believe the trial could have implications beyond treatment by influencing how pediatricians identify and refer infants with suspected peanut allergy.
"I think 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," Mack said. "Early introduction appears to be best, but for those kids that fail at early introduction, I envision a scenario where patients are rapidly sent to the allergist for rapid treatment right on the spot."
He added that if THRIVE produces positive results, pediatricians and allergists may adopt a more streamlined referral pathway for infants who experience allergic reactions during peanut introduction.
"This is something that I think will change how we triage, change how we approach this, and lead to a prioritization of these kids," Mack said. "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."
DBV Technologies CEO Daniel Tassé said the initiation of participant screening represents an important milestone in expanding the company's clinical development program into infants. If successful, the THRIVE study could provide evidence supporting earlier, noninvasive intervention for peanut allergy during a period when immune responses may be most modifiable.
**Editor’s Note: This is part 2 in a 2-part interview.




