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

185

News (Medical) associated with Lebrikizumab

31 Mar 2026
·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
·www.biopharmadive.com

United rises on IPF results; Biogen scores positive lupus data and an approval

Today, a brief rundown of news from United Therapeutics and Biogen, as well as updates from Eli Lilly, Novo Nordisk and Aurinia Pharmaceuticals that you may have missed.Shares of United Therapeutics were up nearly 15% Monday morning on data from a late-stage clinical trial that assessed the companys already-marketed drug Tyvaso in patients with a rare lung condition known as idiopathic pulmonary fibrosis. Another, similar trial had previously hit its main goal. According to United, the newer results from a study titled TETON-1 were even better. After a year of treatment, patients given Tyvaso showed an absolute change in forced vital capacity of 130.1 mL. FVC is a key test for potential IPF treatments, as it measures lung health by quantifying how much air a patient can forcefully exhale after taking a deep breath. Tyvaso is currently used for a lung-related illness called pulmonary arterial hypertension. The data from TETON-1 should favorably shift the Tyvaso narrative away from the nuances of the competitive PAH market and towards the more green field blockbuster opportunity of IPF, according to Leerink Partners analyst Roanna Ruiz.Biogen on Monday said the Food and Drug Administration approved a higher-dose version of the companys spinal muscular atrophy drug Spinraza. The new regimen will be available in the coming weeks, according to Biogen, and allows for an accelerated loading phase. Two 50 milligram doses are administered 14 days apart, followed by 28 milligram maintenance dose injections every four months thereafter. The approval should keep Biogens SMA franchise durable and serve as a bridge until the companys next-generation medicine, salanersen, comes to market, wrote Jefferies analyst Andrew Tsai in a note to clients. Tsai added that his team expects the Spinraza franchise, which generated roughly $1.5 billion in sales last year, to remain resilient (or even grow) despite the SMA market possibly getting more crowded over the next couple years.The FDA has approved Novo Nordisks Awiqli as an adjunct treatment to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. The FDA based its decision on data from four studies that enrolled nearly 2,700 patients and tested weekly shots of Awiqli. According to Novo, this is the first onceweekly basal insulin option approved for adult Type 2 diabetes patients in the U.S., and thereby provides a new treatment solution that fits different patient routines and preferences. The Denmark-based drugmaker said it plans to launch Awiqli in its FlexTouch devices in the states in the second half of this year.In other Biogen news, the companys experimental drug litifilimab succeeded in a mid-stage study of patients with cutaneous lupus erythematosus, an autoimmune condition marked by skin inflammation, scaly rashes and oral sores. According to a Saturday announcement from Biogen, the first part of the AMETHYST trial met its main objective, with litifilimab demonstrating an 11.8% higher reduction in disease activity compared to a placebo after 16 weeks of treatment. The results were consistent with what researchers observed in LILAC, a separate CLE study. A targeted antibody drug, litifilimab is also being evaluated as a treatment for another kind of lupus known as SLE.Aurinia Pharmaceuticals has agreed to acquire Kezar Life Sciences, a San Francisco-area biotech developing small molecule drugs for cancer and conditions where the immune system mistakenly attacks the bodys own healthy cells. For each share of Kezars common stock, Aurinia has agreed to hand investors just shy of $7 in cash, plus one non-transferable contingent value right that floats potential payments if certain goals are hit. The deal, announced Monday, comes after Kezars board of directors conducted a strategic review and unanimously determined that Aurinias proposal is in the best interests of the biotech and its stockholders. Kezars most advanced drug, zetomipzomib, is being evaluated as a possible treatment for autoimmune hepatitis, SLE and a kidney illness caused by SLE. Aurinias CEO Kevin Tang previously made a bid as an activist shareholder to acquire Kezar in 2024.Eli Lillys Ebglyss kept moderate-to-severe eczema in check for up to four years in a late-stage clinical trial, the company disclosed Friday. The open-label extension study showed 80% of participants who were given a once-monthly maintenance injection of Ebglyss experienced a durable response without the need for topical corticosteroids. Three-quarters of participants achieved EASI90 a test that signals near-complete skin clearance while 78% reported significant itch relief. An antibody drug, Ebglyss works by inhibiting an immune system-regulating protein called IL-13. Sanofi and Regenerons Dupixent also targets IL-13 as well as the related protein IL-4. '

Clinical ResultDrug ApprovalAcquisition

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

100 Deals associated with Lebrikizumab

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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
Chronic rhinosinusitis with nasal polyps	Phase 3	United States	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	China	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Japan	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Argentina	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Belgium	Eli Lilly & Co.	29 Apr 2024

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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	aisrkutdgz(pkuiudiqat) = ovrhpjnknu cusjpefkbw (ogdbgtejyt ) Met View more	Positive	16 Mar 2026
				Placebo+Topical corticosteroids	aisrkutdgz(pkuiudiqat) = nimhoxvfzn cusjpefkbw (ogdbgtejyt ) Met View more
NCT04392154 (ADjoin, Literature \| NEWS) Manual	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	103	lebrikizumab Q8W	mhgkcyuomu(ywypryeqef) = llufhimkim ljhvyldunq (plwvenaijc, 48.3 - 75.8) View more	Positive	10 Nov 2025
				lebrikizumab Q4W	mhgkcyuomu(ywypryeqef) = zmawpfrezy ljhvyldunq (plwvenaijc, 60.9 - 85.1) View more
NCT04146363 \| NCT04178967 \| NCT04392154 (ADvocate1, Pubmed \| Clin Exp Dermatol)	Phase 3	Dermatitis, Atopic	-	Lebrikizumab every 4 weeks	zxnxebjmmz(lvxallkxgu) = wodhrtmsvt uguptbpawt (ngaaejijzg ) View more	Positive	08 Nov 2025
				Lebrikizumab every 2 weeks	zxnxebjmmz(lvxallkxgu) = ibyxrftqkm uguptbpawt (ngaaejijzg ) View more
NCT06243198 (CTgov)	Phase 1	-	24	Lebrikizumab (250 mg Lebrikizumab)	tgptneljds = kxphyfewvj mrgaijehmb (dytoiqhxwa, caughyvuxe - rkbkosqwet) View more	-	12 Sep 2025
				Lebrikizumab (500 mg Lebrikizumab)	tgptneljds = dwrmbafqva mrgaijehmb (dytoiqhxwa, yzdzmzitce - dipumerkfb) 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)	qlkcfmvjgx(xpzkbaauxt) = xfanbgvkxi ctsvlyanvw (kakiisdwfz ) 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)	msxolxzlwk(hdtxohdwyc) = zwzvwdyztz uazdyetzrd (vqxhuyaunv, dfpkfculiz - groccbsnhj) View more	-	03 Aug 2025
				Lebrikizumab (Open-Label Extension Addendum: Lebrikizumab Q8W)	msxolxzlwk(hdtxohdwyc) = ozwnpqcyyb uazdyetzrd (vqxhuyaunv, kvyjwvjvyb - vrofbkfoky) View more
NCT04392154 (ADjoin, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Moderate Atopic Dermatitis Maintenance Interleukin-13	-	Lebrikizumab 250 mg Q2W	sjtilwdhgb(svxydssheg) = 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 txevphrirp (dwrwwapdkw )	Positive	01 Aug 2025
				Lebrikizumab 250 mg Q4W
NCT06444165 (CTgov)	Phase 3	Dermatitis, Atopic	55	Lebrikizumab Pen	fkzmwrdeex = aebpanxrng neuyguiitg (rezyhbzdhe, znybcftshj - mzpwszaxzh) View more	-	29 Jul 2025
NEWS Manual	Phase 3	Dermatitis, Atopic	90	Ebglyss	pstadhkure(iiepciykqg) = rwvfhvklqz mgppakvusj (asyjemjioc ) View more	Positive	22 Jul 2025
NCT05372419 (ADmirable, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	90	Lebrikizumab (Lebrikizumab 250 mg Q2W)	hlwfqtvlsc = mfdpqfshql ponmfgvfkd (sihjdndtad, lpcxmwmdqp - fcyaerkyni) View more	-	11 Jun 2025
				Lebrikizumab (Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W)	zauabbcwal = nbnmrgaddd uwwrsdeasj (whrmlfdyxm, fbbigndvkj - gnmhtjcvvt) View more

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Lebrikizumab

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Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation