Study: University of Michigan investigation of dupilumab for chronic idiopathic dermal hypersensitivity reaction, with Regeneron collaboration. 12

Design and measurements: The reproduced registry text describes a single-group, open-label study, with 10 actual participants. Eligibility required clinical and biopsy evidence of unexplained rash lasting at least six weeks, with moderate-to-severe involvement. All participants were to receive dupilumab through week 24, with laboratory testing, examinations, and selected skin biopsies during approximately 28 weeks of participation. 12

What is established: The reproduction displays completed status, but its status and date fields are not sufficient to verify a final analyzed sample. No clinical-response or immunologic effect size was verified. A phase IV label does not establish approval or proven efficacy for this particular rash indication. 12