Lebrikizumab Improves Hand and Foot AD in Phase 3b ADtouch Trial
Key Takeaways
- In the Phase 3b ADtouch trial, lebrikizumab-lbkz (Ebglyss) met the primary endpoint, with 53% of patients achieving clear or almost clear hands and feet at week 16 compared with 27% receiving placebo.
- Improvements were also reported in hand and foot itch, pain, patient satisfaction, and quality of life, with several prespecified outcomes statistically significant under multiplicity control.
- No new safety signals were reported. Lilly has submitted the ADtouch data to the FDA for a potential label update addressing localized atopic dermatitis with moderate-to-severe hand and foot involvement.
Lebrikizumab-lbkz (Ebglyss; Eli Lilly and Company) improved skin clearance, itch, and pain compared with placebo among adults and adolescents with moderate-to-severe atopic dermatitis (AD) affecting the hands and feet, according to Phase 3b ADtouch results presented at the European Academy of Dermatology and Venereology Congress 2026.
ADtouch was a randomized, double-blind, placebo-controlled trial involving 221 patients aged 12 years or older with moderate-to-severe atopic hand and foot dermatitis and an inadequate response to topical therapies. Participants were randomized 1:1 to lebrikizumab 250 mg or placebo every 2 weeks following an initial loading dose. All participants used moisturizer on their hands and feet throughout the 16-week study.
Lebrikizumab Improves Hand and Foot Clearance, Itch, and Pain
At week 16, 53% of patients receiving lebrikizumab achieved clear or almost clear hands and feet, defined as a Hand and Foot Investigator Global Assessment (HF-IGA) score of 0 or 1 with at least a 2-point improvement, compared with 27% receiving placebo. The measure was the study's primary endpoint.
Among patients with a baseline Hand and Foot Peak Pruritus Numeric Rating Scale score of at least 4, 57% receiving lebrikizumab achieved at least a 4-point improvement in itch at week 16 compared with 19% receiving placebo. The corresponding rates for at least a 4-point improvement in pain were 59% and 19%, respectively.
Patient-reported outcomes also favored lebrikizumab. Among patients dissatisfied with their hand dermatitis clearance at baseline, 77% receiving lebrikizumab reported being satisfied or very satisfied with clearance at week 16 compared with 40% receiving placebo. Rescue medication through week 16 was used by 6% and 18% of patients, respectively.
Treatment-emergent adverse events occurred in 41.8% of lebrikizumab-treated patients and 39.6% of placebo-treated patients; all were reported as mild or moderate. No new safety signals were identified.
Lebrikizumab is US Food and Drug Administration (FDA)-approved for moderate-to-severe AD in patients aged 12 years or older who weigh at least 40 kg and whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.