Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.
- The families/patients must do weekly assessments of disease severity and itch at home and have a remote sensor that can go over a dressing to measure rub/pat/scratch
- There are 2 blood draws (baseline and 16 weeks)
- There are 8 in-person visits
Limited transportation costs may be covered and participants will also receive compensation for their time ($935 for 24 wk completion). Please email NUdermfirstname.lastname@example.org for more information.
- Male or female > 6 months of age at screening visit
- Clinical diagnosis of a genetic skin disorder at the screening visit, ideally with genetic or histological confirmation.
- Must have had the gene with one or more variants identified by genotyping. If the genotype has not been performed or has not been performed at a CLIA-approved laboratory, be willing to provide a sample (saliva, buccal swab, blood) for genetic testing before starting the dupilumab.
- Subjects < 6 months of age at screening visit.
- Unable to provide informed consent or assent (or who do not have consent from a Legally Authorized Representative if < 18 years).
- Diagnosis of ichthyosis vulgaris as the sole inherited disorder
If you have any questions or are interested in participating in this clinical trial, please contact:
Northwestern Dermatology CTU
- Phone: 312-503-5944
- Email: NUdermemail@example.com '
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Get more information on ClinicalTrials.gov