EBGLYSS monotherapy met its primary endpoint with more than half of patients achieving clear or almost clear skin on their hands and feet (HF-IGA 0/1) by Week 16, with significant skin clearance as early as one month
EBGLYSS delivered significant itch and pain relief, with significant itch improvements as early as two weeks in the Phase 3b ADtouch study
In first-of-its-kind patient satisfaction data, nearly eight out of 10 patients treated with EBGLYSS reported being satisfied or very satisfied with hand clearance at Week 16
INDIANAPOLIS, Sept. 30, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that EBGLYSS (lebrikizumab-lbkz) monotherapy met its primary and secondary endpoints at Week 16 in the Phase 3b ADtouch study, showing significant and rapid improvements in hand and foot skin clearance, itch and pain in adults and adolescents with moderate-to-severe hand and foot atopic dermatitis (AD). In first-of-its-kind patient satisfaction data for moderate-to-severe hand AD, significantly more patients treated with EBGLYSS were satisfied or very satisfied with how much the skin on their hands had cleared than those on placebo, as measured by the validated Atopic Hand Dermatitis Clearance Satisfaction (AHDCS) scale. These late-breaking results will be presented at the European Academy of Dermatology and Venereology (EADV) Congress, Sept. 30-Oct. 3 in Vienna.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, M.D., senior vice president of Lilly Immunology development. "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."
EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity and slow dissociation rate.2,3,4 The cytokine IL-13 is a primary cytokine in AD, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.5,6
"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, M.D., 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. "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."
Atopic dermatitis affecting the hands and feet can carry substantial burden for people living with this chronic skin disease, despite involving limited areas of the body.1,7 Up to 60% of people with AD have hand involvement, and roughly 30% also have foot involvement.8,9
The ADtouch clinical trial evaluated EBGLYSS monotherapy in adults and adolescents with moderate-to-severe hand and foot AD who had an inadequate response to topical therapies. In the ADtouch clinical trial, participants were randomized to receive placebo or EBGLYSS every two weeks. The trial assessed physician- and patient-reported outcomes across skin clearance, itch, pain, patient satisfaction with hand clearance, and quality of life. Patients enrolled had moderate-to-severe hand and foot involvement, though most had limited AD across the rest of the body. At baseline, patients were living with severe itch of the hands and feet, moderate pain and substantial impairment in quality of life, despite limited overall skin involvement.
The safety of EBGLYSS in ADtouch was consistent with the known profile in adult and adolescent patients, with no new safety signals observed. Treatment-emergent adverse events were reported in 41.8% of patients receiving EBGLYSS and 39.6% receiving placebo, and all were mild or moderate in severity.1 The most common (≥5%) adverse reactions reported with EBGLYSS were nasopharyngitis and upper respiratory tract infection. Adverse events leading to discontinuation were reported in 0.9% of patients receiving EBGLYSS and 2.7% receiving placebo.
Lilly has submitted these data to the U.S. Food and Drug Administration (FDA) and plans to submit to select global regulatory authorities for a potential label update to include these data for localized AD with moderate-to-severe hand and foot involvement.
Almirall will also present EBGLYSS data at EADV, including five-year results from the Phase 3b ADlong trial highlighting the long-term durability of EBGLYSS in adults with moderate-to-severe AD. These results reinforce previously reported four-year ADlong results for EBGLYSS.10
EBGLYSS is approved in the U.S. to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. In June 2026, the U.S. FDA approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of EBGLYSS for subcutaneous use, building on its already approved once-monthly maintenance dose. EBGLYSS can be used with or without topical corticosteroids.11
Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe.
About ADtouch
ADtouch (NCT06921759) is a Phase 3b, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of EBGLYSS 250 mg dosed every two weeks (Q2W) in patients with moderate-to-severe atopic hand and foot dermatitis for a total of 16 weeks. Adults and adolescents (ages 12-17, weighing at least 88 pounds, ≥40 kg) with history of moderate-to-severe atopic dermatitis, atopic hand and foot dermatitis of at least one year's duration, involvement in at least two of four hand and foot anatomical areas, a Hand and Foot Investigator Global Assessment (HF-IGA) score of moderate (3) or severe (4), Hand and Foot Peak Pruritus Numeric Rating Scale (NRS) score of 4 or higher, and inadequate response to topical therapies were eligible to enroll. Patients (N=221) were randomized 1:1 to receive EBGLYSS 250 mg or placebo every two weeks after an initial loading dose, with all participants applying moisturizer to the hands and feet throughout the study.1 The approved maintenance dose of EBGLYSS is 250 mg every four weeks (EU and U.S.) or 250 mg every eight weeks (U.S.), after taking EBGLYSS every two weeks for the four-month initial dosing phase (or later once achieving adequate clinical response).11
About EBGLYSS(lebrikizumab-lbkz)
EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.1,3,4 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Rα subunit of the IL-13Rα1/IL-4Rα heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is implicated as a primary cytokine tied to the pathophysiology of atopic dermatitis, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.1
The EBGLYSS Phase 3 program in atopic dermatitis consists of seven key global studies evaluating more than 1,600 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), long-term extension (ADjoin) and adolescent open-label (ADore) studies. The program also includes a study assessing the impact of EBGLYSS on vaccine immune response in adults (ADopt-VA). EBGLYSS has been studied in patients with skin of color (ADmirable) and in dupilumab-experienced patients (ADapt).
EBGLYSS was approved in the U.S., Japan and Canada in 2024 and in the European Union in 2023. EBGLYSS is a first-line biologic treatment, administered with or without topical corticosteroids, that offers every-four-week (EU and U.S.) or every-eight-week (U.S.) maintenance dosing for adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis that is not well-controlled with topical prescription therapies.1 In the U.S., the recommended initial starting dose of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is 250 mg every four weeks or every eight weeks.1
Lilly is committed to serving patients living with moderate-to-severe atopic dermatitis and is working to enable broad first-line biologic access to EBGLYSS for patients not well-controlled with topical prescription therapy through commercial insurance. Lilly has coverage with all three major national pharmacy benefit managers, and EBGLYSS is covered on nearly 95% of national commercial plans. We have expanded Medicaid coverage and are pursuing similarly broad Medicare coverage as part of Lilly's health equity and affordability initiative. Through Lilly Support Services for EBGLYSS, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.