Lilly: Lebrikizumab (EBGLYSS) meets primary endpoint in Phase 3b ADtouch for hand and foot atopic dermatitis

ADtouch Phase 3b findings

In the randomized, double-blind ADtouch trial (N=221), EBGLYSS (lebrikizumab-lbkz) monotherapy met its primary endpoint: 53% of treated patients achieved HF-IGA 0/1 with ≥2-point improvement at Week 16 versus 27% for placebo. Skin clearance differences were significant as early as Week 4 (17% vs 6%). Fewer EBGLYSS patients required rescue medication through Week 16 (6% vs 18%).

Patient-reported outcomes

EBGLYSS produced rapid, clinically meaningful symptom relief: 57% reached ≥4-point improvement in HF-Peak Pruritus NRS at Week 16 versus 19% with placebo, with significant itch relief seen by Week 2. For pain, 59% achieved ≥4-point improvement at Week 16 versus 19% with placebo, with measurable benefit within one to two weeks. Patient satisfaction and quality-of-life measures also favored EBGLYSS (77% satisfied/very satisfied vs 40%; QoLHEQ improvement 57% vs 28%).

Safety and regulatory status

The safety profile in ADtouch aligned with prior data: treatment-emergent adverse events occurred in 41.8% (EBGLYSS) versus 39.6% (placebo), mostly mild or moderate; common reactions included nasopharyngitis and upper respiratory tract infection. Adverse-event discontinuations were 0.9% versus 2.7%. Lilly has submitted the ADtouch data to the FDA and plans submissions to select global regulators to support a potential label update for localized moderate-to-severe hand and foot AD.

Trial population and dosing

ADtouch enrolled adults and adolescents (≥12 years, ≥40 kg) with ≥1 year of hand/foot atopic dermatitis and inadequate response to topical therapies. Participants were randomized 1:1 to EBGLYSS 250 mg every two weeks or placebo, with moisturizer use maintained throughout the 16-week study.