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

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.

INDICATION AND SAFETY SUMMARY
EBGLYSS^® (EHB-glihs) is an injectable medicine used 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. EBGLYSS can be used with or without topical corticosteroids. 

It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg). 

Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.

Before using

Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you:

• Have a parasitic (helminth) infection.
• Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS.
• Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.
• Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Possible side effects

EBGLYSS can cause serious side effects, including:

• Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
  • breathing problems or wheezing
  • swelling of the face, lips, mouth, tongue or throat
  • hives
  • itching
  • fainting, dizziness, feeling lightheaded
  • skin rash
  • cramps in your stomach area (abdomen)
• Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.

The most common side effects of EBGLYSS include:

• eye and eyelid inflammation, including redness, swelling, and itching
• injection site reactions
• shingles (herpes zoster)

These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

How to take

• See the detailed "Instructions for Use" that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes. 
• Use EBGLYSS exactly as prescribed by your healthcare provider. 
• EBGLYSS is given as an injection under the skin (subcutaneous injection). 
• If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver. 
• If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time.

Learn more
EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com.

This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you. 

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EBGLYSS^®, its delivery device base, and Lilly Support Services™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, they are the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ^® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about EBGLYSS (lebrikizumab-lbkz) as a treatment for patients with moderate-to-severe atopic dermatitis and the timeline for future readouts, presentations, and other milestones relating to EBGLYSS and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results to date or that EBGLYSS will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 

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. Simpson EL, 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(5):863-871.e11. doi:10.1016/j.jaad.2018.01.017
3. Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547. doi:10.1007/s13555-023-00947-7.
4. Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.10116/j.jmb.2013.01.024.
5. Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54–62. doi:10.1111/all.13954.
6. Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489. doi:10.1016/j.jid.2018.12.018
7. Quaade AS, Simonsen AB, Halling AS, et al. Prevalence, incidence, and severity of hand eczema in the general population - a systematic review and meta-analysis." Contact Dermatitis 2021;84(6):361-74.
8. Lio PA, Armstrong A, Gutermuth J, et al. Lebrikizumab Improves Quality of Life and Patient-Reported Symptoms of Anxiety and Depression in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024;14(7):1929-43.
9. Holm JG, Agner T, Clausen ML, Thomsen SF. Quality of life and disease severity in patients with atopic dermatitis. J Eur Acad Dermatol Venereol. 2016;30(10):1760-7.
10. Weidinger S, Irvine AD, Thaçi D, Szepietowski JC, Biedermann T, Agell H, Valls J, Coll R, Castilla-Fernández G, Romero W, Reich K. Lebrikizumab showed sustained efficacy and safety through 5 years in patients with moderate-to-severe atopic dermatitis: Results from the ADlong long-term extension trial. 2026. ClinicalTrials.gov identifier: NCT05916365.
11. EBGLYSS. Prescribing Information. Lilly USA, LLC.

SOURCE Eli Lilly and Company