Lebrikizumab Improves Hand and Foot Atopic Dermatitis in Phase 3b Trial

Lebrikizumab-lbkz (Ebglyss) monotherapy improved hand and foot clearance, itch, and pain at 16 weeks in adults and adolescents with moderate-to-severe atopic dermatitis (AD), according to results from the phase 3b ADtouch trial announced by Eli Lilly and Company. Clear or almost clear hands and feet were achieved by 53% of participants who received lebrikizumab compared to 27% receiving placebo.^1,2

The findings will be presented at the European Academy of Dermatology and Venereology (EADV) Congress, being held September 30 to October 3, 2026, in Vienna.

“For people with hand and foot atopic dermatitis, a relatively small area of affected skin can have an outsized impact on daily life,” Shawn G. Kwatra, MD, chair of dermatology at the University of Maryland School of Medicine, said in the announcement.² "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."

ADtouch was a randomized, double-blind, placebo-controlled trial involving 221 participants with inadequate responses to topical therapies. Eligible adolescents were aged 12 to 17 years and weighed at least 40 kg. Participants had hand and foot disease for at least 1 year, involvement of at least 2 of 4 anatomical areas, and moderate or severe investigator-rated disease. Most had limited AD elsewhere, despite substantial symptom and quality-of-life burden.¹

Participants received lebrikizumab 250 mg or placebo every 2 weeks after an initial loading dose, with moisturizer applied throughout. The primary endpoint was a Hand and Foot Investigator Global Assessment score of 0 or 1 with at least a 2-point improvement at week 16. At week 4, 17% receiving lebrikizumab vs 6% receiving placebo met this endpoint.¹

Among participants with baseline symptom scores of at least 4, a 4-point or greater improvement in peak itch occurred in 57% vs 19% at week 16; corresponding pain responses were 59% vs 19%. Itch improvement was statistically significant by week 2. These week-16 endpoints and the primary endpoint were significant under multiplicity control, according to Lilly.^1,2

Among participants initially dissatisfied with hand clearance, 77% receiving lebrikizumab vs 40% receiving placebo reported being satisfied or very satisfied at week 16. Rescue medication was required by 6% vs 18%, respectively. These outcomes complement investigator-rated clearance but do not establish comparative effectiveness against other systemic treatments.¹

Treatment-emergent adverse events occurred in 41.8% of the lebrikizumab group and 39.6% of the placebo group; all were described as mild or moderate. Nasopharyngitis and upper respiratory tract infection were the most common adverse reactions reported with lebrikizumab. Discontinuations attributable to adverse events occurred in 0.9% vs 2.7%. Lilly reported no new safety signals.^1,2

Lebrikizumab selectively inhibits IL-13 signaling. Earlier development included the randomized phase 2 TREBLE trial in adults whose AD was inadequately controlled with topical corticosteroids.³ Lilly’s subsequent phase 3 program included ADvocate 1 and 2 monotherapy trials and ADhere, evaluating combination treatment with topical corticosteroids.²

According to Lilly, US approval covers moderate-to-severe AD in patients aged 12 years or older weighing at least 40 kg when topical prescription therapies provide inadequate control or cannot be used. The company reports FDA approval of every-8-week maintenance dosing in June 2026. ADtouch evaluated every-2-week induction treatment, not that maintenance schedule.²

The 16-week, placebo-controlled findings support short-term efficacy in this localized disease population. Full reporting of confidence intervals, missing-data methods, and longer follow-up would help clarify precision and durability. Lilly reported submitting the findings to the FDA for a potential label update.²

References

1. Silverberg K, Simpson E, Laquer V, et al. Lebrikizumab is effective in patients with atopic hand and foot dermatitis: 16-week results from the randomized, double-blind, placebo-controlled ADtouch trial. European Academy of Dermatology and Venereology (EADV) Congress. Sept. 29-Oct. 3, 2026.
2. 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. News 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
3. Simpson EL, Flohr C, Eichenfield LF, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018;78:863-871.e11. doi:10.1016/j.jaad.2018.01.017