The National Institutes of Health (NIH) announced Thursday that it is launching a clinical trial to test the monoclonal antibody dupilumab as a treatment to reduce asthma attacks and improve the lung function of children with poorly controlled allergic asthma who live in low-income urban settings. As part of the trial, researcher will also seek to gain additional knowledge about the activity levels of gene networks associated with asthma and how the treatment affects health outcomes in the children, most of whom are Black or Hispanic.
The trial, Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (PANDA), is co-funded by the National Institute of Allergy and Infectious Diseases (NIAID). Dupilumab is approved by the U.S. Food and Drug Administration as an add-on maintenance treatment for certain types of moderate-to-severe asthma in people ages six 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,” said NIAID director Anthony S. Fauci, M.D., in a press release. “The PANDA trial is an important step toward these goals.”
While dupilumab is already approved for some asthma indications, little is known about its ability to treat Black and Hispanic, despite the fact that these populations suffer from severe asthma attacks in higher numbers than other ethnicities. The Phase 2 PANDA trial—which is also receiving funding from Regeneron Pharmaceuticals and Sanofi—will seek to fill this knowledge gap.
The NIAID-funded Childhood Asthma in Urban Settings (CAUSE) Network is conducting the PANDA study at seven medical centers located in Aurora, Colorado; Boston; Chicago; Cincinnati; New York and Washington, D.C. Leading the trial is Daniel J. Jackson, M.D., professor of pediatrics and medicine in the School of Medicine and Public Health at the University of Wisconsin-Madison.
An earlier NIAID study, discovered that a number of different networks of genes are activated together and are associated with asthma attacks in minority children and adolescents living in low-income urban settings. Some of these gene networks are specifically associated with a systemic allergic response called Type 2 inflammation, shown to play a major role in asthma among this population. Dupilumab was chosen for the trial to see if its known activity of blocking interleukin 4 and interleukin 13—two proteins known to be active in Type 2 inflammation—will help reduce asthma symptoms.
The trial will enroll approximately 240 participants ages 6 to 17 years who have poorly controlled allergic asthma that is prone to attacks and who have biological markers of Type 2 inflammation. The children will be assigned at random in a 2:1 ratio to receive injections of either dupilumab or a placebo every two weeks for a year. All participants also will receive asthma care based on guidelines developed under the auspices of the National Heart, Lung, and Blood Institute, part of NIH. To determine the effectiveness of the treatments, NIH investigators will measure participants’ lung function and inflammation multiple times over the duration of the study. Nasal swabs will also be collected after the children receive their injections, and nasal swabs and blood samples will also be collected should any of those enrolled in the trial come down with a cold.
To better understand the activity of the gene networks identified in the earlier trial, nasal swab samples with be analyzed by RNA sequencing in an effort to understand the relationship between the gene networks and the participants’ response to the drug. Of special interest will be changes that occur in the gene networks over time and whether this information can be used to predict clinical response.
More information about the PANDA trial, including study site locations and contacts, is available in ClinicalTrials.gov under study identifier NCT05347771.