FDA & Government News

Lebrikizumab Meets Phase 3 End Points in Pediatric Atopic Dermatitis

In topline results from Lilly’s ADorable-1 trial, pediatric patients aged 6 months to 18 years had higher rates of skin clearance and itch improvement vs placebo, according to a press release from Eli Lilly and Company.

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Lebrikizumab has shown significant efficacy in treating moderate-to-severe atopic dermatitis (AD) in pediatric patients aged 6 months to 18 years. In the Phase 3 ADorable-1 trial, 63% of participants achieved a 75% reduction in EASI score, and 44% attained an IGA score of 0 or 1 by Week 16, compared to lower percentages in the placebo group. The 363 enrolled patients received weight-based lebrikizumab alongside topical corticosteroids. Safety profiles remained consistent with previous studies, with common adverse events being upper respiratory infections. Lilly plans to submit the findings to regulatory agencies for potential label expansion.

Original Source(s)

Lebrikizumab Meets Phase 3 End Points in Pediatric Atopic Dermatitis

  • by Kerri Miller

  • March 17, 2026

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