Clinical Trials

Phase 1 Clinical Trial of Dupilumab for All EB Types

Date Updated:
EB Type: All
Name of Company: Northwestern University
Recruitment Status: Active, Not Recruiting

About the Study

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 NUderm-research@northwestern.edu for more information.

Trial Entry Criteria

Inclusion Criteria: 

  • 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. 

Exclusion Criteria: 

  • 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 

Click here for more inclusion and exclusion criteria

Contacts & Location

If you have any questions or are interested in participating in this clinical trial, please contact: 

Location:

Ann & Robert H. Lurie Children's Hospital of Chicago    
Chicago, Illinois, United States, 60611    

Get more information on ClinicalTrials.gov

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