A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema who are not Adequately Controlled With Topical Corticosteroids or When This Treatment is not Medically Advisable (LUMINE)

Start Date24 Apr 2026

Sponsor / Collaborator

Almirall SA

CTIS2024-519811-32-00

/ Not yet recruitingPhase 4

An interventional, Open-label Study to Evaluate the effect of lebrikizumab on eczema and Skin Barrier Function parameters in lesional and non-lesional skin in Adults and Adolescents with Moderate to Severe Atopic Dermatitis

Start Date01 Apr 2026

Sponsor / Collaborator-

NCT07352566

/ Not yet recruitingPhase 4IIT

Utilization of a Cutaneous Therapy In Situ Microdevice

This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.
The small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of California, San Francisco

100 Clinical Results associated with Lebrikizumab

100 Translational Medicine associated with Lebrikizumab

100 Patents (Medical) associated with Lebrikizumab

247

Literatures (Medical) associated with Lebrikizumab

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases

Review

Author: Yang, Xuefan ; Ruan, Dandan ; Li, Sitong ; Chen, Xiang ; Lin, Jiacheng ; Qiu, Xinlan ; Li, Jiaqi ; Ju, Qiang ; Mo, Xiaohui

PURPOSE:

Emerging evidence suggests rosacea as a recognizable adverse event during dupilumab therapy. This study aimed to investigate the potential association between dupilumab and rosacea using pharmacovigilance data and to characterize the clinical features of dupilumab-associated rosacea (DAR) through a review of reported cases.

MATERIALS AND METHODS:

We utilized the FDA Adverse Event Reporting System (FAERS) database (2017-2024) to identify disproportionality signals using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayesian Geometric Mean (EBGM). To contextualize these findings, we performed a focused narrative review of 8 publications comprising 10 DAR cases with extractable individual data.

RESULTS:

A significant disproportionality signal was identified across all four methods (ROR 3.873; PRR 3.872; IC 1.865 with IC025 1.653; EBGM 3.642), with reports predominantly in adults and females. In the case review, a consistent phenotype emerged: papulopustules on persistent centrofacial erythema with frequent burning; facial predominance with occasional extension to neck, scalp, or upper trunk; frequent Demodex detection by scraping, KOH, or in vivo imaging; and occasional granulomatous histology. Onset ranged from approximately 2 weeks to 21 months, including one post-discontinuation case. Most patients improved with rosacea-directed therapy (topical ivermectin or metronidazole; anti-inflammatory-dose doxycycline). However, dechallenge or rechallenge patterns and the need for dose-interval extension, temporary interruption, or switching biologic (e.g., lebrikizumab, upadacitinib) in a subset support a drug-related pattern at the reporting level.

CONCLUSIONS:

DAR represents a distinct clinical entity from dupilumab-associated head and neck dermatitis, which is eczematous and typically responds to antifungals or calcineurin inhibitors. While disproportionality signals indicate association rather than incidence or causality and are subject to reporting bias, clinicians should be aware of this potential adverse event to ensure appropriate management.

02 Mar 2026·Dermatitis

Decision-Making Factors for Systemic Therapies in Atopic Dermatitis: A Clinical Review.

Review

Author: Mehta, Apoorva ; Guttman-Yassky, Emma ; O'Hagan, Ross ; Lamb, Angela J ; Levine, Jasmine

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that significantly impairs quality of life. In recent years, treatment has advanced from broad immunosuppressants to targeted biologics and small-molecule therapies that modulate type 2 inflammation and itch signaling. Dupilumab, tralokinumab, lebrikizumab, and nemolizumab are now FDA-approved biologics with demonstrated efficacy and favorable long-term safety, while oral Janus kinase inhibitors (JAKis) such as abrocitinib, upadacitinib, and baricitinib often provide rapid disease control but carry black-box warnings. Comparative trials highlight faster itch relief with JAKis but durable disease control and safety advantages with biologics. The expanding treatment landscape necessitates individualized therapy selection. Key clinical considerations include patient age, pregnancy status, infection, malignancy, or thromboembolic risk, comorbid conditions, and history of adverse effects. Equally important are patient-centered preferences such as dosing frequency, route of administration, storage logistics, and willingness to self-inject. Access and affordability also influence care, with many manufacturers offering copay support and patient assistance programs. Future directions emphasize head-to-head comparative studies, biomarker development for precision treatment, and equitable access to advanced therapies. This narrative review synthesizes current evidence on biologics and JAKis in AD, outlining efficacy, safety, and practical decision-making factors to guide dermatologists in aligning therapies with both clinical context and patient priorities.

01 Mar 2026·JOURNAL OF DERMATOLOGY

Clinical Outcomes of Tralokinumab and Lebrikizumab in Japanese Atopic Dermatitis Patients With Persistent Head and Neck Dermatitis After Long‐Term Treatment With Dupilumab: A Single‐Center Retrospective Study

Letter

Author: Chijiwa, Chika ; Okada, Yoshiki ; Tada, Yayoi ; Suzuki, Shoya ; Hiura, Azusa ; Kamata, Masahiro ; Tomura, Yayoi ; Hayashi, Kotaro ; Watanabe, Ayu ; Tanaka, Takamitsu

183

News (Medical) associated with Lebrikizumab

12 hours ago
·www.prnewswire.com

Lilly's EBGLYSS (lebrikizumab-lbkz) delivered up to four years of durable disease control for patients with moderate-to-severe atopic dermatitis

In the ADlong Phase 3b study, nearly all EBGLYSS-treated patients achieved meaningful skin improvement (EASI-75) for up to four years 75% of patients achieved a high bar of near-complete skin clearance (EASI-90) and 78% experienced significant itch relief (Pruritus NRS ≤4), one of the most bothersome symptoms for patients 80% of patients achieved durable results without the need for topical corticosteroids March 27, 2026 -- New long-term data show Eli Lilly and Company's (NYSE: LLY) EBGLYSS (lebrikizumab-lbkz) delivered durable skin clearance and relief from persistent itch for up to four years for patients with moderate-to-severe atopic dermatitis (eczema) in an open-label extension study offering once-monthly maintenance injection. Interim findings from the first year of the ADlong Phase 3b study will be presented at the American Academy of Dermatology (AAD) Annual Meeting, taking place March 27-31 in Denver.1 "These data underscore our unwavering commitment to expanding what people with moderate-to-severe atopic dermatitis can achieve with treatment," said Adrienne Brown, executive vice president and president, Lilly Immunology. "For too long the focus has been around symptom management and many patients struggle to achieve consistent disease control despite cycling through topical treatments. EBGLYSS is helping transform this treatment paradigm—allowing people the opportunity to reimagine life without the frequent interruptions caused by flares or topicals applied 2-3 times per day." 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 atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.5,6 In the ADlong study, the majority of patients achieved a high bar of near-complete skin clearance and significant itch relief with up to four years of continuous EBGLYSS treatment. Most patients (77%) were on EBGLYSS monotherapy, and 80% achieved results without topical corticosteroids. In addition, 80% achieved these outcomes with EBGLYSS monthly maintenance dosing during the study. The safety of EBGLYSS in the first year of the ADlong study was consistent with the known profile in patients with moderate-to-severe atopic dermatitis, regardless of dose frequency, and no new safety signals were observed. The majority of adverse events were mild or moderate and did not lead to discontinuation. Reported treatment-related adverse events in the study included conjunctivitis (6.9%) and injection-site reactions (0.6%). The ADlong study is ongoing and will continue for an additional year of treatment. These results reinforce previously reported long-term results for EBGLYSS for patients with moderate-to-severe atopic dermatitis. In addition, a post-hoc analysis presented at Maui Derm Hawaii 2026 on EASI-75 stable responders showed less than one flare per patient per year with EBGLYSS monthly maintenance dosing used as monotherapy.7 "There is still an unmet need for people with moderate-to-severe atopic dermatitis who frequently experience unpredictable flares and are in need of treatment options that go beyond just symptomatic relief and address the underlying inflammation driving skin symptoms and persistent itch," said Emma Guttman-Yassky, M.D., Ph.D., The Waldman Professor and Health System Chair, Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York. "These four-year findings reinforce that EBGLYSS has the potential to deliver durable disease control, helping patients flare less with or without topicals." Lilly continues to raise the standard of care in dermatology and boldly invest in the next wave of immunology innovation, which includes big bets on next-generation modalities, the targeted expansion of small molecules and advancing novel science that uncovers the potential of incretins. Lilly recently shared topline findings from the TOGETHER-PsA and TOGETHER-PsO trials investigating the concomitant use of ixekizumab and an incretin-based therapy to treat adults with psoriatic disease and obesity or overweight with at least one additional weight-related comorbid condition. Lilly's investigational therapies include DC-853, a novel oral IL-17 inhibitor being studied for psoriasis, and eltrekibart, a novel monoclonal antibody that targets neutrophil-driven inflammation and is being assessed in hidradenitis suppurativa. Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Lilly's partner Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe. ADlong (NCT05916365) open-label extension study is evaluating the long-term safety and efficacy of EBGLYSS 250 mg dosed every four weeks (Q4W) in patients with moderate-to-severe atopic dermatitis for a total of 108 weeks. Adult and adolescent (ages 12–17, weighing ≥40 kg) patients from select countries in Europe who completed the 100-week ADjoin extension study, including patients who completed the ADore trial (52 weeks), the ADhere trial (16 weeks), and Week 16 responders who completed the ADvocate 1 and 2 trials (52 weeks), were eligible to enroll in ADlong. Patients (N=174) in this analysis receive open-label EBGLYSS 250 mg Q4W, regardless of their previous treatment in ADjoin (Q2W or Q4W dose). The approved maintenance dose of EBGLYSS is 250 mg once monthly, after taking EBGLYSS every two weeks for the four-month initial dosing phase (or later once achieving adequate clinical response).8 Intermittent use of topical rescue medications and short-term systemic treatments was allowed.1 If response was below EASI-50, Q2W could be used and thereafter Q4W could be resumed. EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.3,4,8 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 eczema, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.8 The EBGLYSS Phase 3 program in atopic dermatitis consists of seven key global studies evaluating over 1,600 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), long-term extension (ADjoin), adolescent open-label (ADore) and pediatric (ADorable 1 and 2) studies. EBGLYSS is also being studied in allergic rhinitis and chronic rhinosinusitis with nasal polyps. 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 with the option of monotherapy that offers once-monthly 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.8 EBGLYSS 250 mg/2 mL injection is dosed as a single monthly maintenance injection following the initial phase of treatment. 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 a single monthly injection (250 mg every four weeks) which can be used with or without topical corticosteroids.8 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 94% of commercially insured patients have coverage through national health 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, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients. 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 nearly 150 years, and today our medicines help 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. 1 Weidinger S, et al. Efficacy and Safety of Lebrikizumab is Maintained up to 4 Years in Patients With Moderate-to-Severe Atopic Dermatitis: first year of ADlong Long-Term Extension Trial. American Academy of Dermatology Annual Meeting. March 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 Merola J, et al. Patients with Atopic Dermatitis with a Stable Response to Lebrikizumab Flare Less in a Long-Term Study: A Post-hoc Analysis of the ADjoin Study. Maui Derm Hawaii. January 2026 8 EBGLYSS. Prescribing Information. Lilly USA, LLC. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

30 Mar 2026
·allsci.com

Sanofi’s amlitelimab meets Phase III endpoints in atopic dermatitis with extended 12-week dosing interval

Sanofi (NASDAQ: SNY) reported Phase III data from three trials of amlitelimab in moderate-to-severe atopic dermatitis, showing that the anti-OX40L antibody met primary endpoints across monotherapy and combination settings — with efficacy at a dosing interval of once every 12 weeks that matched the every-four-week regimen. The results, presented as late-breaking research at the 2026 American Academy of Dermatology annual meeting in Denver, position amlitelimab as a mechanistically distinct entrant into a treatment landscape that has grown crowded but remains defined by frequent dosing and incomplete responses. The COAST 1 and COAST 2 trials were randomized, double-blind, placebo-controlled Phase III studies evaluating amlitelimab monotherapy in adults and adolescents aged 12 and older with moderate-to-severe atopic dermatitis. SHORE used the same design but tested amlitelimab in combination with topical corticosteroids, with or without topical calcineurin inhibitors. Across the three trials, 1,786 patients were enrolled at sites spanning North America, Europe, Asia, and Latin America. The primary endpoint for all three studies was the proportion of patients achieving a validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) score of 0 or 1 — clear or almost clear skin — with at least a two-point reduction from baseline at Week 24. Both the Q4W and Q12W amlitelimab arms met this endpoint in each trial.For US and US reference countries, the primary endpoint was vIGA-AD 0/1 with a ≥2-point reduction. Of note, for the EU reference countries and Japan, the studies used co-primary endpoints that included the same vIGA-AD measure plus EASI-75. In COAST 1, vIGA-AD 0/1 rates were 21.1% (Q4W) and 22.5% (Q12W) versus 9.2% for placebo. EASI-75 — the proportion of patients achieving at least 75% improvement in the Eczema Area and Severity Index — reached 35.9% and 39.1% in the Q4W and Q12W arms, respectively, compared to 19.1% for placebo. Itch reduction, measured by a four-point or greater decrease in peak pruritus numerical rating scale, was 22.5% (Q4W) and 24.5% (Q12W) versus 12.7% for placebo. All key secondary endpoints in COAST 1 reached statistical significance. COAST 2 showed a similar pattern, with vIGA-AD 0/1 rates of 25.3% (Q4W) and 25.7% (Q12W) versus 14.8% for placebo. EASI-75 and itch endpoints reached nominal significance, though one secondary endpoint — vIGA-AD 0/1 with barely perceptible erythema — did not achieve statistical significance. The distinction between the two monotherapy trials is worth noting: COAST 2’s higher placebo response rate narrowed the treatment delta, a common challenge in atopic dermatitis trials with geographically diverse enrollment. SHORE, the combination study, produced the highest absolute response rates. vIGA-AD 0/1 was achieved by 28.7% (Q4W) and 32.3% (Q12W) of patients versus 16.8% on placebo plus topical therapy alone. EASI-75 reached 48.1% and 46.8% in the active arms versus 32.3% for placebo. All primary and key secondary endpoints were statistically significant. Across all three trials, Sanofi reported that efficacy was progressively increasing at Week 24 with no evidence of plateau, suggesting that longer treatment durations may yield higher response rates — a pattern that will be tested in the ongoing ESTUARY extension study. The safety profile was consistent with earlier-phase data. The most common adverse events across COAST 1, COAST 2, and SHORE were nasopharyngitis, atopic dermatitis flares, and upper respiratory tract infections, occurring at rates generally comparable to or lower than placebo. Malignancy rates were below 1% and similar between active and placebo groups. No severe injection site reactions or serious gastrointestinal ulceration events were reported. Sanofi disclosed a second case of Kaposi’s sarcoma in the amlitelimab development program, identified in the still-blinded ESTUARY Phase III extension study. Both Kaposi’s sarcoma cases occurred in patients with known risk factors, and both patients discontinued treatment and entered recovery. Out of an estimated 3,778 patients exposed to amlitelimab across all indications, no additional cases have been identified. The signal remains numerically small but warrants monitoring given the immunomodulatory mechanism. Sanofi stated that it “believes that amlitelimab continues to have the potential to be a meaningful and convenient option for patients with AD”. Amlitelimab is a fully human, non-T cell depleting monoclonal antibody that blocks OX40 ligand, a costimulatory molecule involved in the activation and survival of effector T cells. By targeting this upstream pathway, the drug aims to modulate pathogenic immune responses without the broad immunosuppression associated with JAK inhibitors or the cytokine-specific blockade of IL-4/IL-13 antibodies. The non-depleting design distinguishes it from therapies that reduce T cell populations, potentially offering a different safety-efficacy tradeoff. The atopic dermatitis treatment landscape in 2026 includes six approved systemic therapies for moderate-to-severe disease: dupilumab and tralokinumab (both anti-IL-4/IL-13 pathway), lebrikizumab (anti-IL-13), nemolizumab (anti-IL-31 receptor), and the oral JAK1 inhibitors abrocitinib and upadacitinib. All approved injectable biologics require dosing every two to four weeks. Amlitelimab’s Q12W regimen — approximately four injections per year — would represent a substantial reduction in treatment burden if the dosing schedule is maintained in regulatory filings. Cross-trial comparisons are limited by differences in study populations, placebo rates, and endpoint definitions, but the absolute vIGA-AD 0/1 and EASI-75 rates observed in the COAST and SHORE trials are numerically lower than those reported for dupilumab and upadacitinib in their respective pivotal programs. Whether the dosing convenience and mechanistic novelty offset the apparent efficacy gap will be a central question for regulators, payers, and prescribers. Rocatinlimab, developed by Amgen, targets the OX40 receptor rather than the ligand and is also in Phase III development for atopic dermatitis. The two drugs represent competing approaches to the same pathway, and their relative clinical profiles will become clearer as more data emerge. A 2024 review in the Journal of Dermatology and Therapy examined both molecules, noting that while they share a pathway target, their binding sites and downstream effects may differ. Results from ESTUARY, evaluating Q12W maintenance dosing and longer-term safety, are anticipated in the second half of 2026. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Clinical ResultPhase 3Immunotherapy

27 Mar 2026
·www.businesswire.com

Lebrikizumab delivered long-term disease control for up to four years in patients with moderate-to-severe atopic dermatitis

In the ADlong Phase 3b study*, 94% of patients achieved meaningful skin improvement (EASI-75) with up to four years of lebrikizumab treatment, reinforcing the sustained response achieved over time in patients with moderate-to-severe atopic dermatitis 1 . 75% of patients achieved near-complete skin clearance (EASI-90) and 78% experienced meaningful itch relief (Pruritus NRS ≤4), one of the most bothersome symptoms for patients. At AAD, Almirall and its partners also presented more than 15 posters across atopic dermatitis, psoriasis, actinic keratosis and acne, strengthening its commitment to improving patient outcomes and aligned with its leadership in medical dermatology. BARCELONA, Spain--(BUSINESS WIRE)--Almirall, S.A. (ALM), a global biopharmaceutical company focused on medical dermatology, today presented positive long-term interim results from the ongoing Phase 3b ADlong study evaluating the efficacy and safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis (AD). Lebrikizumab delivered near-complete skin clearance and itch relief for up to four years for patients with moderate-to-severe atopic dermatitis, while maintaining its established safety profile. Interim findings from the first year of the ADlong Phase 3b study were presented at the American Academy of Dermatology (AAD) Annual Meeting, taking place March 27-31 in Denver2. “At Almirall, we are committed to advancing skin science with meaningful therapies that improve patients’ lives. These interim data from the ADlong study further support the long-term value of lebrikizumab in treating patients with moderate-to-severe atopic dermatitis, highlighting its potential to fundamentally improve disease control and positively transform patients’ quality of life,” said Karl Ziegelbauer, Chief Scientific Officer at Almirall. “Long-term efficacy is essential in moderate-to-severe atopic dermatitis, a disease characterized by chronic inflammation and unpredictable flares. When a treatment can offer patients sustained control of both skin symptoms and itch over several years, it has the potential to transform daily life and redefine what we consider achievable in AD management,” said Prof Weidinger, University Medical Center Schleswig-Holstein, Department for Dermatology and Allergy. In the ADlong study, the majority of patients achieved near-complete skin clearance and clinically meaningful itch relief with up to four years of continuous lebrikizumab treatment. Most patients (77%) were on lebrikizumab monotherapy, and the majority of patients (80%) achieved these results without topical corticosteroids. In addition, 80% achieved these outcomes with lebrikizumab monthly maintenance dosing during the study. Efficacy results at week 48 of ADlong, up to four years of continuous treatment EASI-75** 94% EASI-90† 75% IGA 0,1‡ 68% Pruritus NRS ≤4§ 78% *Data are reported as observed ** EASI=Eczema Area and Severity Index; EASI-75=75% reduction in EASI from baseline † EASI-90=90% reduction in EASI from baseline ‡ IGA 0,1=Investigator's Global Assessment 0 or 1 ("clear" or "almost clear") § Pruritus NRS=Numeric Rating Scale rating itch from 0-10 with 10 being worst imaginable itch within the past 24 hours The safety of lebrikizumab in this first year of the ADlong study was consistent with the established safety profile in patients with moderate-to-severe atopic dermatitis, and no new safety signals were observed. The majority of adverse events were mild or moderate and did not lead to discontinuation. Reported treatment-related adverse events in the study included nasopharyngitis, URTI and conjunctivitis. The ADlong study is ongoing and will continue for an additional year of treatment. These results reinforce the sustained response achieved with lebrikizumab over time in patients with moderate-to-severe atopic dermatitis3, building on recently published findings showing that continued treatment for two years enabled a substantial proportion of responder population (41%) to achieve complete skin clearance and itch relief4. At AAD, Almirall and its partners shared new data and more than 15 posters across atopic dermatitis, psoriasis, actinic keratosis and acne, reinforcing its commitment to improving patient outcomes through advancing science and a diverse portfolio that uses novel modalities to address debilitating conditions such as hidradenitis suppurativa, alopecia areata, and atopic dermatitis. About ADlong ADlong (NCT05916365) open-label extension study is evaluating the long-term safety and efficacy of lebrikizumab 250 mg dosed every four weeks (Q4W) in patients with moderate-to-severe atopic dermatitis for a total of 108 weeks. Adult and adolescent patients (ages 12–17, weighing ≥40 kg) from Germany and Poland who completed the 100-week ADjoin extension study, including responders from the ADvocate 1 and 2 trials (52 weeks), ADore trial (52 weeks) and the ADhere (16 weeks) trial, were eligible to enroll in ADlong. Patients (N=174) in this analysis receive open-label lebrikizumab 250 mg Q4W, regardless of their previous treatment in ADjoin (Q2W or Q4W dose). The approved maintenance dose of lebrikizumab is 250 mg once monthly, after taking lebrikizumab every two weeks for the four-month initial dosing phase (or later once achieving adequate clinical response)5. Intermittent use of topical rescue medications and short-term systemic treatments was allowed6. If response was below EASI50, Q2W could be used and thereafter Q4W could be resumed. About Lebrikizumab Lebrikizumab (LEB) is a monoclonal antibody that selectively targets the cytokine IL-13 with high affinity, blocking its downstream signaling7,8,9,10,11, while avoiding broader immunosuppression12,13 and preserving IL-13 physiological clearance14. Lebrikizumab is approved in Europe, under the brand name Ebglyss®, for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy15. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe, while Eli Lilly and Company retains rights for development and commercialization in the U.S. and the rest of the world outside Europe. About Almirall Almirall is a global biopharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2025: €1114.5 MM, over 2100 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. Legal warning This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the company considers reasonable. These statements involve risks and uncertainties beyond the control of the company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law. *These results are interim findings from the first year of the ADlong Phase 3b study and will be publicly disclosed at the American Academy of Dermatology (AAD) Annual Meeting, taking place March 27-31, 2026, in Denver (US) 1 Thaçi, et al. Late breaking news EADV 2024, D1T01.2 2 Weidinger S, et al. Efficacy and Safety of Lebrikizumab is Maintained up to 4 Years in Patients With Moderate-to-Severe Atopic Dermatitis: first year of ADlong Long-Term Extension Trial. American Academy of Dermatology Annual Meeting. March 2026 3 Thaçi, et al. Late breaking news EADV 2024, D1T01.2 4 Simpson E, Biedermann T, Kircik L, et al. Raising the bar of efficacy in Atopic Dermatitis: deep response in week 16 responders treated with lebrikizumab over 2 years. J Dermatolog Treat. 2026;37(1):2631233. doi:10.1080/09546634.2026.2631233 5 European Medicines Agency (EMA). Ebglyss: EPAR—Product Information. Accessed February 7, 2026. 6 Weidinger S, et al. Efficacy and Safety of Lebrikizumab is Maintained up to 4 Years in Patients With Moderate-to-Severe Atopic Dermatitis: first year of ADlong Long-Term Extension Trial. American Academy of Dermatology Annual Meeting. March 2026 7 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768. 8 Okragly AJ, Ryuzoji A, Wulur I, Daniels M, Van Horn RD, Patel CN, et al. Binding, neutralization and internalization of the interleukin‑13 antibody, lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535‑1547. 9 Ultsch M, Bevers J, Nakamura G, et al. Structural basis of signaling blockade by anti‑IL‑13 antibody lebrikizumab. J Mol Biol. 2013;425(8):1330‑1339. 10 Tsuji G, Yamamura K, Kawamura K, Kido‑Nakahara M, Ito T, Nakahara T. Novel therapeutic targets for the treatment of atopic dermatitis. Biomedicines. 2023;11:1303. 11 Furue M, Ulzii D, Nakahara T, Tsuji G, Furue K, Hashimoto‑Hachiya A, et al. Implications of IL‑13Rα2 in atopic skin inflammation. Allergol Int. 2020;69:412‑416. 12 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768. 13 Gonçalves F, Freitas E, Torres T. Selective IL‑13 inhibitors for the treatment of atopic dermatitis. Drugs Context. 2021;10:2021‑1‑7. doi:10.7573/dic.2021‑1‑7. 14 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768. 15 European Medicines Agency (EMA). Ebglyss: EPAR—Product Information. Accessed February 7, 2026. https://www.ema.europa.eu/en/documents/product-information/ebglyss-epar-product-information_en.pdf

Clinical ResultPhase 3Drug Approval

100 Deals associated with Lebrikizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D09633	Lebrikizumab	-	DB11914

R&D Status

Approved

10 top approved records.
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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	European Union	Almirall SA	16 Nov 2023
Dermatitis, Atopic	Iceland	Almirall SA	16 Nov 2023
Dermatitis, Atopic	Liechtenstein	Almirall SA	16 Nov 2023
Dermatitis, Atopic	Norway	Almirall SA	16 Nov 2023

Developing

10 top R&D records.
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Indication	Highest Phase	Country/Location	Organization	Date
Nummular eczema	Phase 3	Bulgaria	Almirall SA	24 Apr 2026
Nummular eczema	Phase 3	Germany	Almirall SA	24 Apr 2026
Nummular eczema	Phase 3	Italy	Almirall SA	24 Apr 2026
Nummular eczema	Phase 3	Poland	Almirall SA	24 Apr 2026
Nummular eczema	Phase 3	Spain	Almirall SA	24 Apr 2026
Nasal Polyps	Phase 3	United States	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	China	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Japan	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Argentina	Eli Lilly & Co.	21 Oct 2024
Nasal Polyps	Phase 3	Belgium	Eli Lilly & Co.	21 Oct 2024

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05559359 (ADorable-1, Biospace) Manual	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	363	Lebrikizumab+Topical corticosteroids	eucxpnormu(zzbizpfzos) = qkfhtlylio kejwpmprwx (hgkbhbdopb ) Met View more	Positive	16 Mar 2026
				Placebo+Topical corticosteroids	eucxpnormu(zzbizpfzos) = fjbcuxlitc kejwpmprwx (hgkbhbdopb ) Met View more
NCT04392154 (ADjoin, Literature \| NEWS) Manual	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	103	lebrikizumab Q8W	whjvzhynrd(ipzobpedib) = lsmoevovov nisqnhszad (akfsampgft, 48.3 - 75.8) View more	Positive	10 Nov 2025
				lebrikizumab Q4W	whjvzhynrd(ipzobpedib) = uobtexager nisqnhszad (akfsampgft, 60.9 - 85.1) View more
NCT04146363 \| NCT04178967 \| NCT04392154 (ADvocate1, Pubmed \| Clin Exp Dermatol)	Phase 3	Dermatitis, Atopic	-	Lebrikizumab every 4 weeks	habnjxqpsy(dahlfzbrwv) = nnrbkpmqwu hepvremhfy (bcvsrqahfq ) View more	Positive	08 Nov 2025
				Lebrikizumab every 2 weeks	habnjxqpsy(dahlfzbrwv) = wcyvihrzan hepvremhfy (bcvsrqahfq ) View more
NCT06243198 (CTgov)	Phase 1	-	24	Lebrikizumab (250 mg Lebrikizumab)	taajctkzgd = onhadkxsnb xzpjwnqbsn (gqifmmtdgh, jwnrdbqmhn - zconzmxupx) View more	-	12 Sep 2025
				Lebrikizumab (500 mg Lebrikizumab)	taajctkzgd = xrbpkwlpfw xzpjwnqbsn (gqifmmtdgh, lfnqoockge - qzmqavoolt) View more
NCT05372419 (ADmirable, Pubmed \| Am J Clin Dermatol)	Phase 3	Dermatitis, Atopic	90	Lebrikizumab 250 mg (Fitzpatrick skin phototype IV-VI + Non-White race)	tilzxtyntq(rddujzgapu) = jsvtsymgcr byljqpjhgc (wpamyaflfi ) View more	Positive	01 Sep 2025
NCT04392154 (ADjoin, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	1,153	Lebrikizumab (Open-Label Extension Addendum: Lebrikizumab Q4W)	rppsgvxdet(goqobflhxj) = vdjquldklx cnkmhjmbbb (hzhmokviff, pxvtukgcoo - lbnfidrxje) View more	-	03 Aug 2025
				Lebrikizumab (Open-Label Extension Addendum: Lebrikizumab Q8W)	rppsgvxdet(goqobflhxj) = dskkkjopwu cnkmhjmbbb (hzhmokviff, vjkisqgbsn - outwgtqevq) View more
NCT04392154 (ADjoin, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Moderate Atopic Dermatitis Maintenance Interleukin-13	-	Lebrikizumab 250 mg Q2W	onfvtjkaxi(vntalzqxnd) = During ADjoin, adverse events were reported by 62.2% of patients from ADvocate1&2 and ADhere who received lebrikizumab Q2W or Q4W, with the majority being mild (31.5%) or moderate (27.0%) in severity, and 2.2% leading to discontinuation due to adverse event igwrdrqtyn (zrypjxrrsl )	Positive	01 Aug 2025
				Lebrikizumab 250 mg Q4W
NCT06444165 (CTgov)	Phase 3	Dermatitis, Atopic	55	Lebrikizumab Pen	bvbkuqajdj = birppzdmrr wupjedcjca (jmyhlvuggu, kgboxpfqlu - fyzcwrgytl) View more	-	29 Jul 2025
NEWS Manual	Phase 3	Dermatitis, Atopic	90	Ebglyss	zcizxanpdg(dqiwjtitvf) = aesyxwthkm qswpuxwelx (fagzewyfhd ) View more	Positive	22 Jul 2025
NCT05372419 (ADmirable, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	90	Lebrikizumab (Lebrikizumab 250 mg Q2W)	iztdkqchmt = llyfkmkjvq wjcldlprfd (zqpvrorgvk, wxyesmjicd - gqvgsxavvz) View more	-	11 Jun 2025
				Lebrikizumab (Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W)	bfnxwgndmm = vopqtbhdvk zgvvjmldmj (tdckrqgjxt, dfcbfnezsn - ednfepvgxd) View more

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Lebrikizumab

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