Research Center: National Jewish Health
Location: 1400 Jackson St, Denver, CO 80206, United States
Lead Researcher: Donald Y M Leung, PhD, MD
IRB: This study has been reviewed and approved by the BRANY (Biomedical Research Alliance of New York) Institutional Review Board

Can a new treatment help children with moderate-to-severe eczema? The PELISTAD-EX2 study at National Jewish Health explores how Dupilumab, a medicine already approved for adults, might benefit children aged 6 to 12. This study focuses on improving the skin’s barrier function, reducing water loss, and easing symptoms like itching and pain.

By understanding how Dupilumab works over time, the study aims to offer better options for managing this challenging condition. Children participating in the study will receive treatment and monitoring to see if it can provide long-term relief from eczema.

Please note that parental consent is needed for participants under the age of 18 to participate in this study.

• Participants will receive a new potential treatment for eczema at no cost.
• Participants will be compensated for participating in this study. Compensation will only be provided to eligible participants who complete the study.
• Participants may experience improvements in their eczema symptoms. 
• Participants will be contributing valuable information that may benefit those with eczema in the future.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Children aged 6-12 who are diagnosed with moderate to severe eczema for at least 1 year
• Must have active eczema lesions on the upper limbs or lower limbs
• Must not have used Dupilumab in the past 6 months prior to day 1 of this study
• Must not be allergic to any active substance or to any of the excipients of Dupilumab
• Must be able to attend 10 study visits at the research site over approximately 2 years

The study team will explain the research in its entirety but some details are:

• Participants will be asked to receive Dupilumab treatment according to a weight-tiered dosing regimen, starting with the first dose administered at the study site and subsequent doses administered at home by a trained parent/caregiver.
• Participants will be asked to apply an emollient twice daily for the study’s duration and document its use in an e-diary provided on a smartphone.
• Participants will be asked to complete various surveys, including POEM, CDLQI, Sleep Disturbance, Worst Itch NRS, Worst Skin Pain NRS, and Sleep Disturbance NRS, throughout the study.
• Participants must be comfortable with having full body photos taken. These photos will be taken in a way that hides any identifying features, and participants will keep their underwear on during the process. At each visit, the study team will take photos of the same body areas, as well as the participant’s full body.

National Jewish Health
National Jewish Health opened in 1899 in response to the great number of destitute individuals suffering from tuberculosis (then known as consumption) who flocked to Denver for the climate’s supposed beneficial effects. At the time, no institution in Denver would admit penniless consumptives and many poor victims of the disease lived and died on the city’s streets. Today, the National Jewish Health has become the only facility in the world dedicated exclusively to groundbreaking medical research and treatment of children and adults with respiratory, cardiac, immune, and related disorders. Although economic realities have made it impossible to continue funding patient care entirely through philanthropy, each year the hospital still provides millions of dollars of free or heavily subsidized care to patients unable to afford total treatment costs.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.