Search reports, ask a question, or jump to a page.
The problem
Intervention: Subcutaneous dupilumab injections (300 mg or 200 mg every 2 weeks for 24 weeks)
Who it was tested with: 24 children and adolescents with confirmed peanut allergy, mean age 11.7 years, in USA and Canada.
The same group is measured before the intervention and again afterwards, with a baseline and an endline and sometimes a midline. Change is visible, but other causes cannot be ruled out.
"A Phase II, 24-week, multicenter, single-arm, open-label, proof-of-concept study was conducted... Children/adolescents with peanut allergy received subcutaneous dupilumab 300 mg (≥ 60 kg) or 200 mg (≥ 20 to < 60 kg) every 2 weeks. The primary endpoint was the proportion of participants who passed a double-blind placebo-controlled food challenge (DBPCFC) with ≥ 444 mg (cumulative) of peanut protein at week 24." The pre-post measurement of food challenge tolerance without a control group constitutes a PRE_POST design that demonstrated no meaningful improvement in desensitization despite immunological changes.
Open-label design with no control group precludes assessment of placebo effects. Small sample size (n=24) and 24-week duration limit generalizability and ability to detect longer-term changes. 96% of participants were treatment-naive, which may not represent broader allergy populations.
Across countries and designs
1 study · 2 countries
