Dupilumab-pediatric Skin Barrier Function and Lipidomics Study in Patients With Atopic Dermatitis in China
Study Purpose
This is a 32-week, open-label, exploratory study with a 4-week screening period, 16-week treatment phase designed to investigate dupilumab's effect on skin barrier function as measured by TEWL before and after STS in approximately 20 pediatric patients with moderate-to-severe AD (not more than 24 patients aged ≥6 and <12 years old), and a 12-week follow-up period. Patients will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 End of Treatment (EoT) phase visit, and every 6-weeks thereafter during the follow-up period and by this will end the study for each participant (End of Study [EoS]). The maximum duration of the study per participant will be 32 weeks (including screening period). Skin barrier function in approximately 10 healthy volunteers (not more than 20 healthy participants aged ≥6 and <12 years old) matched for age (match on age ±2 years), gender, location of targeted lesion area, and study site to the AD cases will be assessed in a similar manner at baseline, and will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 EoT phase visit, and every 6-weeks thereafter during the follow-up period, serving as a reference comparator for skin barrier function.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 6 Years - 12 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05680298 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 4 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sanofi |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Sciences & Operations |
Principal Investigator Affiliation | Sanofi |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Active, not recruiting |
Countries | China |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Atopic Dermatitis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.