Lilly's Lebrikizumab Improves Hand-Foot Atopic Dermatitis

Eli Lilly and Company (Lilly) said lebrikizumab-lbkz (Ebglyss) met its primary and secondary endpoints at Week 16 in the phase 3b ADtouch study, showing improvements in skin clearance, itch, and pain in patients with moderate-to-severe hand and foot atopic dermatitis (AD), the company announced September 30, 2026.¹

"When atopic dermatitis affects the hands and feet, persistent itch and pain can make simple things like walking or holding your child's hand a daily struggle," said Mark Genovese, MD, senior vice president of Lilly Immunology development, in a company press release.¹ "Data from the ADtouch study provide further evidence that EBGLYSS has the potential to rapidly improve skin clearance and itch and provide pain relief in the hands and feet without the need for topical treatments, giving people with moderate-to-severe atopic dermatitis the opportunity to spend less time managing symptoms."

What did the ADtouch trial show?

The primary endpoint, clear or almost clear hands and feet with at least a 2-point improvement, was met by 53% of lebrikizumab patients versus 27% on placebo at Week 16. Itch and pain both improved rapidly, with a 4-point or greater reduction reached by 57% versus 19% for itch and 59% versus 19% for pain at Week 16. On the novel Atopic Hand Dermatitis Clearance Satisfaction scale, 77% of patients were satisfied or very satisfied with hand clearance at Week 16, versus 40% on placebo.¹

"For people with hand and foot atopic dermatitis, a relatively small area of affected skin can have an outsized impact on daily life," said Shawn G. Kwatra, MD, Joseph W. Burnett endowed professor and chair in Dermatology, chief of service, Dermatology, University of Maryland School of Medicine and University of Maryland Medical Center, in the release.¹ "Patients treated with lebrikizumab experienced significant improvements in pain and itch, with nearly three times as many patients achieving meaningful pain improvement compared with placebo. The ADtouch data reinforce that disease burden extends beyond what clinicians can see and highlight the importance of evaluating outcomes that matter to people in improving their everyday lives."

How was the ADtouch trial designed?

ADtouch (NCT06921759) is a phase 3b, randomized, double-blind, placebo-controlled study that randomized 221 patients 1:1 to lebrikizumab 250 mg or placebo every 2 weeks, for 16 weeks.¹^,² Eligible patients were 12 years and older, weighed at least 40 kg, had moderate-to-severe hand and foot AD for at least 1 year despite topical therapy, and had a Hand and Foot Investigator Global Assessment score of 3 or 4 at baseline.¹^,²

What is lebrikizumab and what is its regulatory status?

Lebrikizumab is a monoclonal antibody that selectively inhibits interleukin-13 (IL-13), a key driver of AD's inflammatory cycle.¹ Its broader efficacy was shown in the phase 3 ADvocate 1 and 2 trials.³ Lebrikizumab has been approved in the United States since 2024 for patients 12 years and older weighing at least 40 kg, and in June 2026 FDA approved an every-8-week maintenance dosing option, BioPharmInternational previously reported.⁴

Lilly has submitted the ADtouch data to FDA and plans to submit to other regulators, seeking a label update for hand and foot AD.¹ Treatment-emergent adverse events occurred in 41.8% of lebrikizumab patients versus 39.6% on placebo, all mild or moderate, and 0.9% versus 2.7% discontinued due to adverse events.¹

What are the limitations?

These are late-breaking, company-reported results presented at a medical congress rather than peer-reviewed publication, and Lilly's FDA submission does not necessarily guarantee a label update. ADtouch is a supportive phase 3b study of 221 patients, and its findings are specific to the hand-and-foot subgroup. The Atopic Hand Dermatitis Clearance Satisfaction scale used to measure patient satisfaction is a novel instrument without extensive independent validation.

References

1. Eli Lilly and Company. New Phase 3b data show Lilly's Ebglyss (lebrikizumab-lbkz) delivered significant and rapid improvements in skin clearance, itch, pain, and patient satisfaction in people with moderate-to-severe hand and foot atopic dermatitis. Press release. Published September 30, 2026. Accessed September 30, 2026. https://investor.lilly.com/news-releases/news-release-details/new-phase-3b-data-show-lillys-ebglyss-lebrikizumab-lbkz
2. A study to investigate the efficacy and safety of lebrikizumab in participants with moderate-to-severe atopic hand and foot dermatitis (ADtouch). ClinicalTrials.gov; NCT06921759. Updated August 20, 2026. Accessed September 30, 2026. https://clinicaltrials.gov/study/NCT06921759
3. Silverberg JI, Guttman-Yassky E, Thaçi D, et al. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;388(12):1080-1091. doi:10.1056/NEJMoa2206714
4. Eli Lilly and Company. FDA approves Lilly's EBGLYSS (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis. Published June 9, 2026. Accessed June 10, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglyssr-lebrikizumab-lbkz-one-maintenance