This research is studying a drug already approved for the treatment of atopic dermatitis (AD). This research collects health-related information and blood and skin samples to understand if the study drug, lebrikizumab, leads to long-term improvement in AD skin.

Start Date02 Jul 2025

Sponsor / Collaborator

University of Michigan

[+2]

NCT07006792

/ RecruitingPhase 4

A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden

The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy.
Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.

Start Date16 Jun 2025

Sponsor / Collaborator

Eli Lilly & Co.

NCT06921759

/ RecruitingPhase 3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis.
This study lasts up to 32 weeks, including a 6-week screening period, a 16-week treatment period, and a safety follow-up visit 12 weeks after the last dose.

Start Date21 Apr 2025

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Lebrikizumab

100 Translational Medicine associated with Lebrikizumab

100 Patents (Medical) associated with Lebrikizumab

210

Literatures (Medical) associated with Lebrikizumab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Rosacea-like skin reaction under treatment with dupilumab for atopic dermatitis

Article

Author: Augustin, M. ; Wagner, J. N. ; Zirkenbach, F. ; Grote, C.

PURPOSE:

Dupilumab is a widely recommended treatment for moderate-to-severe atopic dermatitis (AD), with known ocular side effects but less frequent cutaneous reactions.

MATERIAL AND METHODS:

This case report details a 52-year-old female patient with atopic dermatitis treated with dupilumab. After an initially successful treatment, the patient developed a rosacea-like dermatitis. At first, dupilumab was continued alongside doxycycline, metronidazole gel and ivermectin cream.

RESULTS:

Following a worsening of her skin condition, dupilumab was discontinued. Lebrikizumab was introduced, leading to significant regression of the lesions.

CONCLUSIONS:

This case highlights a rare paradoxical skin reaction to dupilumab, potentially linked to the blockade of IL-4Rα, which may shift the immune response towards a Th1/Th17 phenotype. The findings suggest that alternative therapies, such as IL-13 inhibitors, should be considered when cutaneous side effects arise during dupilumab treatment.

01 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Lebrikizumab improves head/neck/face dermatitis and erythema and does not increase treatment-emergent adverse events of head/neck/face erythema in patients with moderate-to-severe atopic dermatitis.

Article

Author: Elmaraghy, Hany ; Piruzeli, Maria Lucia Buziqui ; Hong, H Chih-Ho ; Eyerich, Kilian ; Murase, Jenny E ; Staumont-Sallé, Delphine ; Strowd, Lindsay ; Bangert, Christine ; Yang, Fan Emily ; Rueda, Maria Jose ; Pau-Charles, Ignasi ; Atwater, Amber Reck ; Chovatiya, Raj ; Deleuran, Mette ; Zhong, Jinglin

PURPOSE OF THE STUDY:

Head, neck (HN), and face involvement in atopic dermatitis (AD) poses a major psychological burden and can be challenging to effectively treat. New appearance of HN dermatitis has been reported with biologics used to treat AD. Lebrikizumab (LEBRI), a monoclonal targeting IL-13, is approved for AD treatment in the US, Europe and Asia. We evaluated HN dermatitis improvement using the HN Eczema Area and Severity Index (EASI) and a facial dermatitis questionnaire, along with safety evaluations focusing on HN and facial erythema.

MATERIALS AND METHODS:

Efficacy analyses were performed on placebo (PBO) controlled modified intention-to-treat (mITT) populations from the 16-week induction periods of ADvocate1 and ADvocate2 (pooled) and ADhere studies. Treatment-emergent adverse events (TEAEs) of HN and facial erythema were summarized from eight Phase 2 and 3 clinical trials.

RESULTS:

LEBRI resulted in significantly greater improvements than PBO in EASI HN subscore as early as Week 2 (ADvocate 1&2), with 68.1% improvement at Week 16.

CONCLUSIONS:

LEBRI improved EASI HN subscore and HN EASI clinical signs of erythema and facial dermatitis at Week 16. During the PBO-controlled period, an increased reporting of HN and facial erythema as TEAE was not observed in the LEBRI group and HN and facial TEAEs reporting did not increase with longer exposure.

12 Aug 2025·Dermatitis

Predictive Factors for Poor Responders to Lebrikizumab in Real-World Treatment for Atopic Dermatitis: Transition of Clinical and Laboratory Indexes.

Article

Author: Hagino, Teppei ; Saeki, Hidehisa ; Fujimoto, Eita ; Shiba, Mizuki ; Kanda, Naoko

Background: Some patients with atopic dermatitis (AD) do not sufficiently respond to anti-interleukin-13 antibody lebrikizumab in real-world practice. Identifying predictive factors for poor responders to lebrikizumab is important to optimize treatment strategies for AD. Objective: To clarify predictive factors for poor responders to lebrikizumab, defined as patients with Investigator's Global Assessment >2 at week 12 or 24 of treatment in real-world practice. Methods: From May 2024 to April 2025, we conducted a prospective study in 124 Japanese AD patients treated with lebrikizumab. The transition of clinical and laboratory indexes was evaluated during 24-week lebrikizumab treatment, stratified by poor responders versus responders. We compared baseline characteristics between week 12 and 24 poor responders versus respective responders. Results: Both week 12 and 24 responders showed lower magnitudes of decreasing Eczema Area and Severity Index (EASI) throughout 24-week treatment compared with respective responders. Lactate dehydrogenase levels in both week 12 and 24 responders significantly decreased and plateaued at week 4, while there was no significant decrease in both week 12 and 24 poor responders. Total eosinophil count in both week 12 and 24 responders slightly increased at week 4 and 12, while there was no significant increase in both week 12 and 24 poor responders. Week 12 poor responders had higher baseline EASI compared with responders. Week 24 poor responders had higher body mass index (BMI) compared with responders. Conclusions: Higher baseline EASI may predict week 12 poor responders to lebrikizumab, while higher BMI may predict week 24 poor responders. These baseline characteristics could help optimize treatment for AD.

157

News (Medical) associated with Lebrikizumab

11 Aug 2025
·www.globenewswire.com

Apogee Therapeutics Provides Pipeline Progress and Reports Second Quarter 2025 Financial Results

Positive 16-week data from APEX Phase 2 Part A met all primary and key secondary endpoints for APG777, a potentially best-in-class anti-IL-13 antibody, in moderate-to-severe atopic dermatitis APEX Part A testing every 3- or 6-month maintenance dosing, a significant improvement versus standard of care which is dosed every two weeks, is ongoing with 52-week readout anticipated in 1H 2026 Driven by strong enrollment, APEX Phase 2 Part B of APG777 readout accelerated to mid-2026 First patient dosed in Phase 1b head-to-head trial of APG279 (IL-13 + OX40L) vs. DUPIXENT in atopic dermatitis, with readout expected in 2H 2026 $621.2 million cash, cash equivalents and marketable securities supports runway into Q1 2028 SAN FRANCISCO and BOSTON, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today provided pipeline progress and reported second quarter 2025 financial results. “We are proud of the strong execution across our pipeline in the first half of 2025, highlighted by the recent 16-week Phase 2 Part A topline readout of the APEX clinical trial, in which APG777 met the primary and key secondary endpoints and demonstrated ability to reduce injection burden for patients. These results reinforce APG777’s potentially best-in-class profile for moderate-to-severe AD as the only biologic being tested out to every 3- and 6-month dosing in maintenance,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “We look forward to continued evaluation of APG777 in Part B of APEX, where we are testing APG777 at multiple doses to identify the dose to take forward into Phase 3 studies which we plan to launch next year. Driven by the positive Part A topline results and strong enrollment, we have accelerated readout timing for Part B to mid-2026. Our momentum extends across our broader pipeline, including the recent initiation of our Phase 1b head-to-head trial of APG279 vs. DUPIXENT in atopic dermatitis, which remains on track to readout in the second half of 2026, and the upcoming readout of healthy volunteer data for APG333 expected in the fourth quarter of this year. With a strong cash position and several potentially value creating clinical milestones expected over the coming quarters, we are well positioned to advance our mission of reshaping the standard of care for patients living with I&I diseases.” “The enthusiasm we’re receiving from patients and physicians has been validating for our program and reinforces our confidence in APG777’s potential,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “We’re encouraged by the strength of the topline data from the APEX Part A study and look forward to sharing additional results at upcoming medical conferences. Today’s approved treatments for atopic dermatitis are associated with an injection burden that can limit disease control and long-term adherence for many patients. In our Part A study, we tested 4 dosing days compared to 9 for standard of care during the first 16-week induction period and we look forward to proving our dosing advantage in maintenance with the potential for 2-4 injections per year compared to 26 for the standard of care. We have seen from other diseases, like psoriasis, the meaningful impact reduced injection burden provides to patients and physicians, and we look forward to reading out the 52-week maintenance portion of APEX Part A in the first half of 2026.” Pipeline Highlights and Upcoming Milestones Apogee reported positive 16-week Part A topline results from Phase 2 APEX trial, underscoring APG777’s potential as a best-in-class monotherapy: APG777 is a novel, subcutaneous (SQ), extended half-life monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of atopic dermatitis (AD). APEX Part A met its primary endpoint, with APG777 demonstrating an Eczema Area and Severity Index (EASI) reduction from baseline of 71.0% compared to placebo at 33.8% (p < 0.001). APG777 also demonstrated absolute EASI-75 of 66.9% compared to 24.6% on placebo (p < 0.001). Several key secondary endpoints were in line with the standard of care, including Validated Investigator Global Assessment (vIGA) 0/1 of 34.9% compared to placebo of 17.3% (p < 0.05), and EASI-90 of 33.9% compared to placebo of 14.7% (p < 0.05). APG777 was well tolerated, with a safety profile consistent with other agents in the class. In TEAEs experienced by 5% or more of patients, only non-infective conjunctivitis was more common in APG777 treated patients, showed no association with drug exposure, and led to no dose modifications, interruptions, or discontinuations. Patients received an induction regimen dosing of 4 days compared to 9 dosing days for standard of care.The APEX Part A maintenance phase is testing dosing every 3- and 6-months and may support long-term disease control with just 2-4 injections per year, compared to 26 with the current standard of care. 52-week data from APEX Part A is expected in the first half of 2026.APEX Part B is testing three doses of APG777 versus placebo, including a high dose regimen modeled to have approximately 90-100% greater exposure than EBGLYSS. Enrollment has remained strong in this global trial, and the 16-week Part B readout has been accelerated to mid-2026.Pending results from Part A maintenance, Part B induction data and regulatory feedback, the company plans to initiate Phase 3 trials of APG777 in 2026. Continued progress for APG777 in expanded indications expected in 2025 and 2026 The Phase 1b trial of APG777 in patients with mild-to-moderate asthma is ongoing, with readout expected in the first half of 2026. The primary endpoint of the trial is safety and tolerability, with secondary endpoints exploring pharmacokinetics (PK) and fractional exhaled nitric oxide concentration (FeNO) suppression of APG777.Apogee plans to conduct Phase 2b trials in asthma and eosinophilic esophagitis (EoE) with trial designs informed by APEX Part B dose optimization as well as the Phase 1b results in asthma. Apogee expects to announce plans for these Phase 2b trials in 2026. First patient dosed in APG279 (APG777 + APG990) Phase 1b head-to-head study against DUPIXENT: APG279 is the company’s first combination treatment, combining APG777 and APG990. APG990 is a novel, SQ, extended half-life mAb targeting OX40L, and the combination with APG777, offers the potential for improved clinical responses over monotherapy across a variety of I&I diseases by targeting Type 1, 2 and 3 inflammation. Apogee’s approach of co-formulating two extended half-life mAbs also provides the potential for first-in-class and best-in-class dosing. In July 2025, Apogee announced that the first patient was dosed in its first-in-class combination trial, a Phase 1b study designed to evaluate safety, PK, pharmacodynamics and efficacy of APG279 vs. DUPIXENT in patients with moderate-to-severe AD. Readout is expected in the second half of 2026. Progress continues in combination approach of APG777 + APG333: APG333 is a novel, SQ, extended half-life mAb targeting thymic stromal lymphopoietin (TSLP), a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions. A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the fourth quarter of 2025.Pending results of the trial and results from the APG777 Phase 1b asthma trial and APEX Part B, Apogee expects to announce plans for its combination approach of APG777 + APG333 in respiratory conditions. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $621.2 million as of June 30, 2025, compared to $681.4 million as of March 31, 2025. Based on current operating plans, Apogee expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into the first quarter of 2028.R&D Expenses: Research and development (R&D) expenses were $55.7 million for the quarter ended June 30, 2025, compared to $33.2 million for the quarter ended June 30, 2024. R&D expenses increased primarily due to further development of our APG777 program, as well as increases in personnel-related expenses and equity-based compensation associated with the growth in the company's R&D team.G&A Expenses: General and administrative (G&A) expenses were $17.5 million for the quarter ended June 30, 2025, compared to $10.9 million for the quarter ended June 30, 2024. G&A expenses increased primarily due to increases in personnel-related expenses and equity-based compensation, primarily driven by increased headcount and an increase in the fair value of equity awards granted. These increases are the result of the company’s expansion of operations to support the growth in its business.Net Loss: Net loss was $66.1 million for the quarter ended June 30, 2025, compared to a net loss of $33.8 million for the quarter ended June 30, 2024. Net loss increased primarily as a result of higher R&D and G&A expenses as described above. About ApogeeApogee Therapeutics is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest I&I markets, including for the treatment of Atopic Dermatitis (AD), asthma, Eosinophilic Esophagitis (EoE), Chronic Obstructive Pulmonary Disease (COPD), and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class profiles through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs; the anticipated timing of the initiation of its clinical trials, including the Phase 2 trial of APG777 in asthma, the Phase 2 trial of APG777 in EoE and the Phase 3 trial of APG777; the expected timing of and results from its clinical trials, including data from Part A and Part B of its APEX Phase 2 trial of APG777 in AD, Phase 1b trial of APG279 in AD, Phase 1 trial of APG333 in healthy volunteers, Phase 1b trial of APG777 in asthma; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of APG777, APG279, APG990, APG333, APG777+APG333, APG808, Apogee’s other product candidates, including combination therapies, and any other potential programs; its planned business strategies; its expected timing for future pipeline updates; and its expectations regarding the time period over which Apogee’s capital resources will be sufficient to funds its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, filed with the SEC on May 12, 2025 and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. APOGEE THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)(In thousands, except share data) JUNE 30,2025 DECEMBER 31,2024 Assets Current assets: Cash and cash equivalents $124,192 $141,789 Marketable securities 381,228 378,864 Prepaid expenses and other current assets 10,702 9,060 Total current assets 516,122 529,713 Long-term marketable securities 115,769 210,416 Property and equipment, net 6,438 1,959 Right-of-use asset, net 10,586 11,365 Other non-current assets 8,857 498 Total assets $657,772 $753,951 Liabilities and stockholders' equity Current liabilities: Accounts payable $5,678 $1,071 Lease liability 4,025 3,234 Accrued expenses and other current liabilities 21,848 24,255 Total current liabilities 31,551 28,560 Long-term liabilities: Lease liability, net of current 6,820 8,597 Total liabilities 38,371 37,157 Commitments and contingencies (Note 9) Stockholders' equity: Common Stock; $0.00001 par value, 400,000,000 authorized, 59,587,430 issued and 58,560,525 outstanding as of June 30, 2025; 400,000,000 authorized, 59,478,725 issued and 58,062,898 outstanding as of December 31, 2024 1 1 Additional paid-in capital 1,046,066 1,021,794 Accumulated other comprehensive income 685 915 Accumulated deficit (427,351) (305,916)Total stockholders’ equity 619,401 716,794 Total liabilities and stockholders’ equity $657,772 $753,951 APOGEE THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS(UNAUDITED)(In thousands) THREE MONTHS ENDEDJUNE 30, SIX MONTHS ENDEDJUNE 30, 2025 2024 2025 2024 Operating expenses: Research and development $55,703 $33,206 $102,090 $61,922 General and administrative 17,462 10,916 34,171 20,381 Total operating expenses 73,165 44,122 136,261 82,303 Loss from operations (73,165) (44,122) (136,261) (82,303)Other income, net: Interest income, net 7,141 10,306 14,981 16,393 Total other income, net 7,141 10,306 14,981 16,393 Net loss before taxes (66,024) (33,816) (121,280) (65,910)Provision for income taxes (72) — (155) — Net loss after taxes $(66,096) $(33,816) $(121,435) $(65,910) Investor Contact:Noel KurdiVP, Investor RelationsApogee Therapeutics, Inc.Noel.Kurdi@apogeetherapeutics.com Media Contact:Dan Budwick1AB Mediadan@1abmedia.com

Phase 1Clinical ResultPhase 2Financial Statement

07 Aug 2025
·firstwordpharma.com

Lilly's beat-and-raise quarter can't escape orforglipron's shadow

Although Eli Lilly's second-quarter financial report blew past analyst estimates on several fronts, prompting the pharma to raise its guidance, uninspiring data for its oral obesity hopeful orforglipron overshadowed an otherwise positive financial quarter, sinking the company's shares by about 14% on Thursday. Lilly's overall sales in the three-month period were $15.6 billion, up 38% year-over-year and beating analyst estimates of $14.7 billion, with results driven by volume growth for its tirzepatide drugs, Zepbound and Mounjaro. Both outperformed expectations, with Zepbound surging 172% to $3.4 billion, while Mounjaro posted $5.2 billion, a gain of 69%. Analysts had expected the drugs to generate about $3 billion and $4.7 billion, respectively. "Tirzepatide…will likely become the bestselling drug in the industry in its third year in the market," CEO David Ricks, "and we've got a lot more coming in the pipeline." However, CVS Health's decision earlier this year to exclude Zepbound from its preferred coverage list as of July 1 has "caused significant disruption" to patients, remarked Chief Financial Officer Lucas Montarce. "While it's still early, we have seen this decision negatively impact Zepbound prescriptions during July, and expect it to be a headwind to the rate of volume growth in Q3." In other key products, second-quarter sales for Lilly's breast cancer treatment Verzenio increased 12% to $1.5 billion. Ebglyss, its therapy for atopic dermatitis, generated $87 million and Alzheimer's disease drug Kisunla posted $49 million. The company raised its sales outlook for the year and now expects between $60 billion and $62 billion, up from a prior range of $58 billion to $61 billion. In addition, 2025 profit is projected to reach $21.75 to $23 a share, up from $20.78 to $22.28 per share. Warning about 'price controls' Ricks also weighed in on some of the drug pricing reforms pushed by President Donald Trump, saying that while he agreed that medical research costs ought to be shared more equitably across developed countries, "it's also true that the US pharmaceutical market has significant defects which shift cost to consumers and increase red tape." Last week, Trump issued letters to 17 major pharmaceutical companies, urging them to lower US drug prices to align with international benchmarks by September 29, or face the use of "every tool in our arsenal" to combat what he called "abusive drug pricing practices" harming American families. However, Ricks called for more nuance. "Negotiated prices in Europe come with broad access, low patient co-pays and without administrative hurdles like prior authorisations. There are also no intermediaries that distort prices, and hospitals do not seek profit by selling medicines and marking them up," the CEO said. "If we import foreign price controls and insert them into a US system that isn't built to function for patients, we risk embracing the worst of two worlds — the low productivity and output of Europe's biopharma sector with the high out-of-pocket and distorted prices of the US insurance market." Culled programmes On the R&D front, Lilly said it also discontinued two Phase II programmes, a KV1.3 antagonist for psoriasis, and mazisotine, a non-opioid SSTR4 agonist for pain that it had licensed from Centrexion in 2019 for $47.5 million upfront. A pair of Phase I programmes have also been axed: an itaconate mimetic in immunology and a SCAP siRNA in metabolic dysfunction-associated steatohepatitis.

Phase 2Financial StatementPhase 1Clinical Trial Failure

22 Jul 2025
·pmlive.com

Eli Lilly/Almirall’s Ebglyss shows promise in atopic dermatitis patients with darker skin tones

Eli Lilly and Almirall’s Ebglyss (lebrikizumab) has been shown to significantly improve the signs and symptoms of atopic dermatitis (AD) in patients with skin of colour, according to phase 3b results newly published in the American Journal of Clinical Dermatology . The open-label ADmirable trial, funded by Lilly, evaluated Ebglyss as a first-line biologic following topical prescription therapies in 90 adult and adolescent patients aged 12 years and older with moderate-to-severe AD and skin of colour, as measured by the Fitzpatrick scale. This included patients self-identifying as Black or African American, Asian, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander. Typically referred to as eczema, AD is an inflammatory condition that causes the skin to become itchy, dry and cracked. It occurs in approximately 7.3% of adults in the US and, of those affected, around 40% have moderate or severe symptoms. AD often presents differently in patients with darker skin tones, who are more likely to experience hardened skin lesions, prurigo nodularis, hyperpigmentation, dyspigmentation and severe skin dryness compared to those with lighter skin tones. Patients in ADmirable, the first Ebglyss phase 3b clinical trial to exclusively investigate adult and adolescent patients with AD and skin of colour, saw significant improvements at week 24, with response rates increasing between week 16 and week 24. Results showed that 78% of Ebglyss-treated patients experienced at least a 75% improvement in disease extent and severity (EASI-75), with more than 88% of patients with the darkest skin tones (Fitzpatrick V and VI). Among those who responded to treatment at week 16, 63% achieved at least a 90% improvement in their eczema extent and severity (EASI-90). Additionally, 60% of patients saw clinically meaningful itch relief, and 64% of those with post-inflammatory hyperpigmented lesions at baseline experienced visible improvement in hyperpigmentation, based on the PDCA-Derm scale. Given as an injection under the skin, Ebglyss is designed to neutralise interleukin 13, a protein that is overexpressed in AD and associated with type 2 inflammation. It already holds approvals to treat AD in adult and paediatric patients. Lilly has exclusive rights for development and commercialisation of Ebglyss in the US and the rest of the world outside Europe, where Almirall has licensed the rights to develop and commercialise the drug as a treatment for dermatology indications.

Clinical ResultPhase 3License out/inDrug Approval

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
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	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	Germany	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Italy	Eli Lilly & Co.	29 Apr 2024
Chronic rhinosinusitis with nasal polyps	Phase 3	Poland	Eli Lilly & Co.	29 Apr 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04392154 (ADjoin, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	1,153	Lebrikizumab (Lebrikizumab Q4W)	lelumvurqc = hcryzghbkl byjrrddrqz (jfexiiwhgi, jqowiogapo - wgpavrlarl) View more	-	03 Aug 2025
				Lebrikizumab (Lebrikizumab Q2W)	lelumvurqc = xbzledmazp byjrrddrqz (jfexiiwhgi, hlqolmgyel - ufzajozhla) View more
NCT04392154 (ADjoin, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Moderate Atopic Dermatitis Maintenance Interleukin-13	-	Lebrikizumab 250 mg Q2W	mxyidgeudr(oxyvkspcab) = 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 epxbbnrbww (hebanmcqrw )	Positive	01 Aug 2025
				Lebrikizumab 250 mg Q4W
NCT06444165 (CTgov)	Phase 3	Dermatitis, Atopic	55	Lebrikizumab Pen	fwagvoczjm = ctvywuzqww jbetxqritz (yojawemogl, xylczpxqqm - ezwdhrsurq) View more	-	29 Jul 2025
NEWS Manual	Phase 3	Dermatitis, Atopic	90	Ebglyss	fublaewseo(tmkiefwdsp) = cruqzqpkdo phchtsufue (ebtwtuiljz ) View more	Positive	22 Jul 2025
["ADmirable"] (Pubmed \| Am J Clin Dermatol)	Phase 3	Dermatitis, Atopic	90	Lebrikizumab 250 mg (Fitzpatrick skin phototype IV-VI + Non-White race)	azvfbcheyg(ccnbulljib) = fpyywjastb dwpvxdlirv (ajdqisgzop ) View more	Positive	15 Jul 2025
NCT05372419 (ADmirable, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	90	Lebrikizumab	ijixokubim = hzpbmapzgc xjhrunwqcf (dkwgheslyt, czfwzpxbni - droyvhkmpb) View more	-	11 Jun 2025
NCT05369403 (ADapt, CTgov)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	86	Lebrikizumab (Lebrikizumab 250mg Q2W)	rgjrqaqakx = exmlxwvywe qsbhaodwgz (kyoptaljvo, hsvarpdysr - zpqxjsvbih) View more	-	19 Mar 2025
				Lebrikizumab (Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W)	lpsqphiuro = wpgownflyw kpghtaabjj (niwgwbayhw, mmvdmqkrtp - xlmkpqlizu) View more
NCT04146363 \| NCT04178967 (Pubmed)	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	-	Lebrikizumab	ivmklssjca(ozlutyquaw) = significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders kvpxiauxjw (fukfkciclh )	Positive	31 Dec 2024
NCT04760314 (ADhere-J, Pubmed) Manual	Phase 3	Dermatitis, Atopic	286	Placebo + TCS	olnfpfngjd(rwfhjrokgr) = kjjppilyah jjvxurgdso (ftzajhviov ) View more	Positive	03 Dec 2024
				Lebrikizumab 250 mg Q4W + TCS	olnfpfngjd(rwfhjrokgr) = rbxeoxrljb jjvxurgdso (ftzajhviov ) View more
NCT04840901 (CTgov)	Phase 1	-	242	Lebrikizumab (Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD))	hkdiyrjxbx(dmjqmtzype) = ruvvmvjsmx upfhbonmlp (jhgzfvgcwn, 31) View more	-	22 Nov 2024
				Lebrikizumab (Test) (Lebrikizumab (Test) - Autoinjector (AI))	hkdiyrjxbx(dmjqmtzype) = ytznhqltdb upfhbonmlp (jhgzfvgcwn, 31) View more

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Lebrikizumab

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