Delving into the Latest Updates on Lebrikizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

ANTI-IL-13, EHB-glihs, Lebrikizumab (genetical recombination) (JAN)

+ [16]

Target

IL-13

Action

inhibitors

Mechanism

IL-13 inhibitors(Interleukin-13 inhibitors)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases+ [3]

Active Indication

Dermatitis, AtopicNummular eczemaChronic rhinosinusitis with nasal polyps+ [5]

Inactive Indication

airway diseaseAirway ObstructionAllergic asthma+ [4]

Originator Organization

Genentech, Inc.

Active Organization

Eli Lilly & Co.

Almirall SAEli Lilly Japan KK

+ [5]

Inactive Organization

Hoffmann-La Roche, Inc.

License Organization

+ [1]

Drug Highest PhaseApproved

First Approval Date

European Union (16 Nov 2023),

Dermatitis, Atopic

RegulationFast Track (United States)

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Structure/Sequence

Sequence Code 142719L

Source: *****

Sequence Code 9082543H

Source: *****

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 Aug 2026

Sponsor / Collaborator

The University of California, San Francisco

CTIS2026-525685-22-00

/ Not yet recruitingPhase 2IIT

Targeting IL-13 in Bullous Pemphigoid: An Investigator-Initiated, Prospective, Multicenter, Proof-of-Concept, Open-Label Pilot Study of Lebrikizumab

Start Date30 Jun 2026

Sponsor / Collaborator-

100 Clinical Results associated with Lebrikizumab

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100 Translational Medicine associated with Lebrikizumab

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100 Patents (Medical) associated with Lebrikizumab

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274

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 ; Chen, Xiang ; Li, Sitong ; 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.

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Lebrikizumab off-therapy remission sustained up to 38 weeks in atopic dermatitis

Article

Author: Gudjonsson, Johann E. ; Okragly, Angela ; Rueda, Maria Jose ; Eyerich, Kilian ; Armstrong, April W. ; Elmaraghy, Hany ; Xu, Chenjia ; Moser, Brian A. ; Bieber, Thomas ; Gallo, Gaia ; Silverberg, Jonathan I. ; Uluckan, Ozge ; Nickoloff, Brian J. ; Wolf, Eric ; Natalie, Chitra R.

AIM OF THE STUDY:

Lebrikizumab monotherapy demonstrated efficacy for adults and adolescents with moderate-to-severe atopic dermatitis (AD). This study aims to evaluate the relationship between lebrikizumab serum levels and stable deep response after treatment cessation in Week 16-responder patients who maintained stable EASI 90 response post-induction up to Week 52.

MATERIALS AND METHODS:

Analysis was pooled from two identically designed, randomized, double-blind, placebo-controlled, phase 3 trials, ADvocate1 (NCT04146363; conducted from September 24, 2019, to May 3, 2022) and ADvocate2 (NCT04178967; conducted from October 29, 2019, to April 28, 2022). The analysis subgroup includes those patients who were Week-16 responders, have been re-randomized to receive placebo (withdrawal arm), and maintained a stable EASI 90 response for at least 80% of visits up to 52 weeks, without rescue medication. Serum lebrikizumab was measured at Weeks 4, 16, 32, and 52.

RESULTS:

During withdrawal, 28% of responders (17/60) maintained a stable EASI 90 response with no or minimal fluctuations, including at Week 52, without rescue medication. Mean serum lebrikizumab decreased by 92% and over 99% from Week 16 to Weeks 32 and 52, respectively (Week 16 = 92.4 μg/mL; Week 32 = 7.3 μg/mL; Week 52 = 0.15 μg/mL).

CONCLUSION:

Lebrikizumab demonstrated off-therapy maintenance of response in an AD patient subset for at least 38 weeks post-discontinuation.

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Raising the bar of efficacy in Atopic Dermatitis: deep response in week 16 responders treated with lebrikizumab over 2 years

Article

Author: Xu, Chenjia ; Biedermann, Tilo ; Figueras, Ignasi ; Agell, Helena ; Simpson, Eric ; Kircik, Leon ; Hu, Chaoran ; Pierce, Evangeline ; Gallo, Gaia ; Vestergaard, Christian ; Chovatiya, Raj ; Casillas, Marta ; Ding, Yuxin

BACKGROUND:

Lebrikizumab, a high-affinity monoclonal antibody targeting interleukin-13, effectively treats moderate-to-severe atopic dermatitis (AD).

METHODS:

Lebrikizumab-treated patients in ADvocate1&2 achieving per-protocol response-IGA (0,1) or EASI 75 at Week 16-were re-randomized 2:2:1 to lebrikizumab 250 mg every 2 weeks (Q2W), Q4W, or placebo (lebrikizumab withdrawal). Patients completing Week 52 could enroll in the extension study, ADjoin. Deep response was defined as IGA (0), EASI 100, or Pruritus Numerical Rating Scale score 0 or 1 (NRS [0,1]). This analysis reports as-observed data.

RESULTS AND CONCLUSIONS:

From Week 16-104, among IGA (0,1) responders at Week 16, increased proportions of patients achieved IGA (0) with lebrikizumab Q2W (33.8% [Nx = 77] to 52.3% [Nx = 44]) and Q4W (29.9% [Nx = 77] to 45.5% [Nx = 55]); among EASI 75 responders at Week 16, increased proportions of patients achieved EASI 100 with lebrikizumab Q2W (21.4% [Nx = 112] to 39.7% [Nx = 68]) and Q4W (20.0% [Nx = 115] to 41.3% [Nx = 80]); and among per-protocol responders, increased proportions of patients reported Pruritus NRS (0,1) with lebrikizumab Q2W (35.2% [Nx = 108] to 57.4% [Nx = 61]) and Q4W (34.2% [Nx = 114] to 55.4% [Nx = 65]). Continued lebrikizumab treatment for 2 years resulted in approximately half of per-protocol responders achieving complete skin clearance (IGA 0) and itch relief, raising the bar of treatment goals for AD patients.

203

News (Medical) associated with Lebrikizumab

09 Sep 2026

·firstwordpharma.com

Evommune ends oral drug's dermatitis programme after second mid-stage setback

After flunking a mid-stage chronic spontaneous urticaria study in June, Evommune's oral MRGPRX2 antagonist, EVO756, suffered yet another setback — this time failing to clear a Phase IIb trial in moderate-to-severe atopic dermatitis (AD). Reacting to the news, the company's shares cratered nearly 27% in after-hours trading on Tuesday.With EVO756's urticaria programme already discontinued, Evommune has now decided to end AD development as well, leaving the drug’s remaining hopes pinned on its migraine indication. A mid-stage migraine prophylaxis study is currently underway.The AD trial randomised 121 adults to receive one of three EVO756 doses or placebo over a 12-week treatment period. Top-line results showed the trial failed to meet its main efficacy goal, with neither dose of EVO756 demonstrating a significant percentage change in Eczema Area and Severity Index (EASI) score from baseline at week 12. The study also fell short on secondary endpoints.HC Wainwright analysts earlier said that the company considered a profile similar to Galderma's Nemluvio (nemolizumab) — roughly 15% placebo-adjusted EASI improvement alongside meaningful itch relief — potentially adequate for an oral therapy, with greater lesion efficacy expected to widen its positioning."We are disappointed that this trial… did not meet its primary endpoint, particularly given the need for new treatment options for patients suffering from AD," said Eugene Bauer, chief medical officer of Evommune, noting that EVO756's favourable safety and tolerability, however, supported "its continued evaluation in migraine prophylaxis."Evommune, meanwhile, is strongly banking on its long-acting injectable SAFA-IL-18BP fusion protein EVO301 in AD, which delivered a positive Phase IIa readout in February, demonstrating efficacy comparable with Sanofi and Regeneron's Dupixent (dupilumab) and Eli Lilly's Ebglyss (lebrikizumab). A Phase IIb study is expected to commence mid-next year. (For more, read KOL Views Q&A: Evommune faces uphill battle in atopic dermatitis but there may be role for upstarts – one in particular).The biotech landed a $150-million IPO last November and went on to raise an additional $125 million in a private placement this year after EVO301's success. It maintains an operational runway through 2029.

Phase 2Clinical ResultIPOPhase 1

26 Aug 2026

·allsci.com

TRexBio’s TNFR2 agonist shows human proof-of-mechanism in Phase I

South San Francisco-based TRex Bio, Inc. (TRexBio) has reported positive Phase Ia results for TRB-061, a selective tumor necrosis factor receptor 2 (TNFR2) agonist being developed for atopic dermatitis (AD). The healthy-volunteer study provided initial human evidence that the drug can selectively expand regulatory T cells (Tregs), supporting the company's proposed mechanism ahead of Phase Ib testing in patients. In single ascending-dose cohorts, TRB-061 was generally well tolerated, with no treatment-related serious adverse events, dose-limiting toxicities, or treatment-related discontinuations. All treatment-emergent adverse events were mild or moderate. Pharmacokinetics were approximately dose proportional, while pharmacodynamic testing showed reproducible expansion of Tregs, including CD39-positive Tregs, together with increases in the immunoregulatory biomarkers IL-10 and CCR8. The PK/PD profile supports dosing every four weeks or potentially longer, according to TRexBio. The company selected 24 mg and 50 mg doses for the ongoing Phase Ib portion of the study in adults with moderate-to-severe AD, with topline results expected in mid-2027. That study will assess Treg expansion in lesional skin as well as peripheral blood, providing an early test of whether the pharmacodynamic activity observed in healthy volunteers translates into affected tissue and clinical benefit. TRB-061 takes a different approach from approved AD therapies, which primarily block inflammatory cytokines or downstream signaling pathways. TNFR2 is highly expressed on activated Tregs, immune cells that help restrain excessive inflammatory responses. Selective agonism of the receptor is intended to expand and enhance these immunoregulatory cells without activating TNFR1, which mediates many of the pro-inflammatory effects associated with tumor necrosis factor signaling. TRexBio has previously presented translational data identifying altered Treg programs in AD skin and supporting TNFR2 as a regulator of local immune homeostasis. The mechanism remains at an early stage of clinical validation. TRB-061 is being tested against a backdrop of established biologics including Dupixent (dupilumab), Adbry (tralokinumab), and Ebglyss (lebrikizumab), as well as oral JAK inhibitors including Rinvoq (upadacitinib) and Cibinqo (abrocitinib). Unlike those agents, TRB-061 is intended to restore an upstream immunoregulatory pathway rather than directly suppress individual inflammatory signals. TRexBio describes TRB-061 as the first TNFR2 agonist to enter clinical development for an inflammatory disease. Other TNFR2-targeting clinical programs have largely pursued receptor antagonism or depletion in oncology, while Nektar Therapeutics has disclosed a separate TNFR2 agonist, NKTR-0165, for inflammatory diseases that has not yet entered clinical testing. The Phase Ib readout will therefore be the first meaningful test of whether TRB-061's Treg-expanding activity can translate into therapeutic efficacy in AD. Spot something wrong? Report an issue with this article

Phase 1Clinical ResultImmunotherapyADCAACR

13 Aug 2026

·www.globenewswire.com

New MotherToBaby Study Targets Pregnancy Data Gap for Newer Eczema Treatment

The FDA has determined that human pregnancy data for Ebglyss® remain insufficient. By enrolling U.S. and Canadian participants, this study will help generate the evidence needed to inform future treatment decisions.San Diego, CA, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Pregnant women with moderate-to-severe eczema and their healthcare providers face a difficult evidence gap: how to make treatment decisions when human pregnancy data for newer therapies remain limited. MotherToBaby has launched a new observational pregnancy study to learn more about Ebglyss® (lebrikizumab) when used during pregnancy to treat moderate-to-severe atopic dermatitis (eczema). The study is now enrolling pregnant women across the United States and Canada. The research is part of MotherToBaby Pregnancy Studies’ ongoing commitment to generating evidence that helps patients and healthcare providers make informed decisions about medication use during pregnancy. The study is led by internationally recognized epidemiologist Christina D. Chambers, PhD, MPH, Professor of Pediatrics at the UC San Diego’s School of Medicine and one of the world's leading experts in pregnancy exposure research. Dr. Chambers has spent more than three decades leading landmark observational studies that have advanced understanding of medication safety during pregnancy. Atopic dermatitis affects many women during their reproductive years, and managing the condition during pregnancy can be challenging. While effective treatment is important for the health and well-being of the pregnant woman, information about the use of newer medications during pregnancy remains limited. This study aims to help fill that knowledge gap. The MotherToBaby Ebglyss Pregnancy Study will follow participants throughout pregnancy and after delivery to better understand pregnancy and infant outcomes associated with Ebglyss exposure. Researchers will compare pregnancy outcomes among women who used at least one dose of Ebglyss a few months before or during pregnancy with those of women who have atopic dermatitis and received other systemic treatments, phototherapy, or no systemic treatment during pregnancy. These comparison groups will help researchers better understand the effects of both the medication and the underlying condition. The study is observational, meaning participants will not be asked to take any study medication or change the treatment recommended by their healthcare providers. Instead, researchers collect health information through interviews and medical record review, with participants' permission, to better understand real-world pregnancy outcomes. Observational research plays a critical role in generating evidence about medication safety during pregnancy because pregnant women are rarely included in clinical trials. "Every participant who shares their experience helps expand the evidence available to support informed eczema treatment decisions during pregnancy," said Christina D. Chambers, PhD, MPH. "Our goal is to provide reliable, science-based information that benefits patients, healthcare providers, and future families." MotherToBaby is seeking pregnant individuals across the United States and Canada who: Are currently pregnantHave used Ebglyss during pregnancyHave been diagnosed with atopic dermatitis (eczema) with or without treatment for our comparison group Participation is voluntary, and all information is kept confidential. The study is expected to continue enrolling participants through 2033, helping build one of the largest sources of information on pregnancy outcomes associated with Ebglyss and atopic dermatitis treatment. Individuals interested in participating or learning more about the study can contact MotherToBaby at 877.311.8972 or visit https://mothertobaby.org/ongoing-study/ebglyss-lebrikizumab-lbkz. About MotherToBaby MotherToBaby is the nation's leading source of evidence-based information on medications and other exposures during pregnancy and while breastfeeding. MotherToBaby provides free, expert information to the public and healthcare providers through phone, text, chat, and email, while conducting pregnancy studies that help improve knowledge about the safety of medications and vaccines during pregnancy. Media Contact: Nicole Chavez, nchavez@mothertobaby.org, 619-368-3259

Clinical Study

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	Germany	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
Chronic rhinosinusitis with nasal polyps	Phase 3	Bulgaria	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Canada	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Denmark	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Finland	Eli Lilly & Co.	29 Apr 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02546700 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	309	Placebo (Placebo: Biomarker-High)	fpzobycvcy(rlvofedizl) = izwfvcrimq soaictawwk (jntmjyipau, wiqdjridvi - edftlytdzl) View more	-	10 Sep 2026
NCT02546700 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	309	Lebrikizumab (Lebrikizumab: Biomarker-High)	fpzobycvcy(rlvofedizl) = owzsznnpok soaictawwk (jntmjyipau, lmnonpphzn - orzbkfyxdu) View more	-	10 Sep 2026
NCT02104674 (CTgov)	Phase 3	Asthma	313	Lebrikizumab (Double-Blind: Lebrikizumab)	asssfkztaw(urokikrdqx) = trqovcsxmx kknxugqkui (lkgeqclqez, 0.033) View more	-	17 Jul 2026
NCT02104674 (CTgov)	Phase 3	Asthma	313	Placebo (Double-Blind: Placebo)	asssfkztaw(urokikrdqx) = hxwzichzqi kknxugqkui (lkgeqclqez, 0.032) View more	-	17 Jul 2026
NCT05990725 (ADhope, CTgov)	Phase 3	Eczema \| Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	260	Lebrikizumab	mcfunmoqoz = ndfxtywtyn quffqwodnd (edakwuppdx, pqceatkjfn - rrdssrdilb) View more	-	17 Jul 2026
NCT01875003 (ACOUSTICS, CTgov)	Phase 3	Asthma	346	Placebo+Lebrikizumab	yncytdrhrc = oeszbqebnp cmdcrxyqbm (rnzifruomq, cyhelpqkzr - kbxbjvlnee) View more	-	30 Jun 2026
NCT04392154 (ADjoin, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Dermatitis, Atopic	267	Lebrikizumab 250 mg Q2W	spihznueeb(cehctchtvq) = Most adverse events (AEs) were mild (29.2%) or moderate (33.3%) in severity. wtekjvgjzn (ilqsiemvso )	Positive	19 Jun 2026
NCT05372419 (ADmirable, AAD2026)	Phase 3	Dermatitis, Atopic	90	Lebrikizumab 250 mg	yzbksubbuu(uujhdlcyfy) = nzmgtnosbh zfaroojlnq (uepwhdsnnl ) View more	Positive	27 Mar 2026
ADvocate 1 (AAD2026)	Phase 3	Dermatitis, Atopic	215	Lebrikizumab (did not achieve protocol-defined response at Week 16)	ebkfcfstug(lihbohfmff) = mhgjdrzvcx ljebavgwim (myhpfvdwdk ) View more	Positive	27 Mar 2026
ADlong (AAD2026)	Not Applicable	Moderate Atopic Dermatitis	174	Lebrikizumab 250mg (Q4W or Q2W)	lgkeacyiyv(dljmqkypvw) = qkgmucnekm kfisldkajs (eiuhvavsbu ) View more	Positive	27 Mar 2026
NCT06339008 (PREPARED-1, AAD2026)	Phase 3	Rhinitis, Allergic, Perennial	418	Lebrikizumab Q2W x16 weeks then every 4 weeks	impgosntah(velmwttdlr) = bkbddxzulv djskgkldww (fyzqahudgw )	Positive	27 Mar 2026
AAD2026	Not Applicable	Dermatitis, Atopic	42	Lebrikizumab	bkujzjniks(eaclehmdro) = fygjpgeabg lmioahqqti (tkhfdznixp ) View more	Positive	27 Mar 2026

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