New clinical trial to evaluate dupilumab in children with asthma living in urban areas
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The NIH launched a clinical trial to assess whether dupilumab can reduce asthma exacerbations and improve lung function and symptoms in children with poorly controlled allergic asthma in low-income urban areas.
Currently, dupilumab (Regeneron/Sanofi) is approved by the FDA as an add-on maintenance treatment for certain moderate to severe asthma types in individuals aged 6 years and older.
“We need to find out how well approved asthma drugs work for disadvantaged children of color living in urban areas, and whether biological markers can help predict how the drugs affect their asthma,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in the press release. “The PANDA trial is an important step toward these goals.”
The Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (PANDA) phase 2 trial is co-funded by the National Institute of Allergy and Infectious Diseases, Regeneron and Sanofi. The trial will be conducted at seven medical centers in Aurora, Colorado; Boston; Chicago; Cincinnati; New York and Washington D.C., and enroll 240 participants aged 6 to 17 years with poorly controlled allergic asthma who are prone to asthma exacerbations with type 2 inflammation biomarkers.
Participants will be randomly assigned to dupilumab injections or placebo every 2 weeks for 1 year.
PANDA will evaluate dupilumab in Black and Hispanic children; severe asthma has disproportionate effects on U.S. children in these racial/ethnic groups. These children will often have many allergies and are exposed to high levels of indoor allergens and traffic-related pollution, which affects asthma control.
Previously, the National Institute of Allergy and Infectious Diseases identified gene networks activated and associated with asthma exacerbation in children and adolescents from historically underrepresented groups who live in low-income urban areas. Because dupilumab specifically blocks interleukin-4 and interleukin-13, researchers hypothesize that dupilumab will reduce asthma exacerbations while improving lung function and asthma symptoms in this patient population.