Lebrikizumab Meets Primary Endpoints in Phase 3 ADorable-1 Trial for Pediatric Atopic Dermatitis

Lebrikizumab demonstrated significant improvements in disease severity and symptoms in infants, children, and adolescents with moderate-to-severe atopic dermatitis (AD), according to Week 16 results from the phase 3 ADorable-1 trial presented at the 2026 Society for Pediatric Dermatology (SPD) Annual Meeting in Minneapolis, Minnesota.¹

Phase 3 ADorable-1 Shows Significant Efficacy Across Multiple Clinical Endpoints

ADorable-1 is a randomized, double-blind, placebo-controlled phase 3 study evaluating lebrikizumab in patients aged 6 months to younger than 18 years with moderate-to-severe AD. Eligible patients had an Eczema Area and Severity Index (EASI) score of at least 16, an Investigator's Global Assessment (IGA) score of 3 or 4, and involvement of at least 10% of body surface area. Participants were randomized to receive lebrikizumab plus topical corticosteroids (TCS) or placebo plus TCS for 16 weeks.¹

The study met both co-primary endpoints at Week 16. Among patients treated with lebrikizumab plus TCS (n = 245), 43.5% achieved IGA 0/1 with a ≥2-point improvement compared with 15.2% of patients receiving placebo plus TCS (n = 118; P < .001). Similarly, 62.6% of patients receiving lebrikizumab achieved EASI-75 versus 21.6% in the placebo group (P < .001).¹

Secondary efficacy endpoints also favored lebrikizumab. Complete or near-complete skin clearance was achieved more frequently with lebrikizumab, including EASI-90 responses in 38.6% versus 11.0% of placebo-treated patients and EASI-100 responses in 13.7% versus 4.6%, respectively. Improvements were also observed in itch, with 34.5% of lebrikizumab-treated patients achieving a ≥4-point improvement in Pruritus Numeric Rating Scale scores compared with 5.5% of placebo-treated patients. Worst scratching/itching Numeric Rating Scale responses favored lebrikizumab (41.6% vs 0.0%), and quality of life improved as measured by Children's Dermatology Life Quality Index/Dermatitis Family Impact, with responder rates of 61.6% versus 36.2%.¹

Treatment-emergent adverse events occurred in 57.1% of patients receiving lebrikizumab and 59.3% of those receiving placebo. Most adverse events were mild or moderate in severity. Serious adverse events were reported in 1.2% and 2.5% of patients, respectively, while discontinuations due to adverse events were uncommon (1.3% vs 7.6%). Investigators reported no new safety signals, and the safety profile was consistent with previous lebrikizumab studies in adolescent and adult populations.¹

In the poster conclusion, the investigators wrote, "In the Phase 3 ADorable-1 study, LEB demonstrated statistically significant and clinically meaningful efficacy versus placebo, meeting both co-primary endpoints of IGA (0,1) with ≥2-point improvement and EASI 75 at Week 16 in patients aged 6 months to <18 years with moderate-to-severe AD. Treatment with LEB resulted in consistent improvements in key measures of disease severity and symptoms (skin clearance, itch, relief, and quality of life). The safety profile of LEB in ADorable-1 was consistent with prior studies in adult and adolescent patients with moderate-to-severe AD, and no new safety findings were identified over 16 weeks of treatment."¹

Reference

1. Eichenfield LF, Ornelas J, Prajapati VH, et al. Lebrikizumab for pediatric patients aged ≥6 months with moderate-to-severe atopic dermatitis: Phase 3 ADorable-1 Week 16 results. Poster POS-014 presented at: Society for Pediatric Dermatology Annual Meeting; July 22-25, 2026; Minneapolis, MN.