Lebrikizumab

Lebrikizumab-lbkz is an IgG4 monoclonal antibody that binds with high affinity and slow off-rate to interleukin (IL)-13 and allows IL-13 to bind to IL-13Rα1 but inhibits human IL-13 signaling through the IL-4Rα/IL-13Rα1 receptor complex. IL-13 is a naturally occurring cytokine that is involved in Type 2 inflammation, which is an important component in the pathogenesis of atopic dermatitis.

• EBGLYSS is indicated for the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.ICD-10: L20.9

• EBGLYSS is contraindicated in patients with prior serious hypersensitivity to lebrikizumab-lbkz or any excipients of EBGLYSS [see Warnings and Precautions ( 5.1 )] . Prior serious hypersensitivity to lebrikizumab-lbkz or any excipients in EBGLYSS.contraindicated

Prior to EBGLYSS treatment, complete all age-appropriate vaccinations according to current immunization guidelines. ( 2.1 ) The recommended dosage of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg (one injection) every 2 weeks until Week 16 or later, when adequate clinical response is achieved. The maintenance dose is EBGLYSS 250 mg every 4 weeks. ( 2.2 ) Administer by subcutaneous injection. ( 2.4 ) 2.1 Vaccination Prior to Administration of EBGLYSS Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions ( 5.4 )] . 2.2 Recommended Dosage The recommended dosage of EBGLYSS is an initial dose of 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. The maintenance dosage is 250 mg every four weeks [see Clinical Studies ( 14.1 )] . 2.3 Concomitant Topical Therapies EBGLYSS can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) may be used, but reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas. 2.4 Important Administration Instructions EBGLYSS is for subcutaneous administration. EBGLYSS is intended for use under the guidance of a healthcare professional. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of EBGLYSS. Adult patients may self-inject, or caregivers may give EBGLYSS after training in subcutaneous injection technique.

Hypersensitivity: Hypersensitivity reactions including angioedema and urticaria, have occurred after administration of EBGLYSS. Discontinue EBGLYSS in the event of a serious hypersensitivity reaction. ( 5.1 ) Conjunctivitis and Keratitis: Report new onset or worsening eye symptoms to a healthcare provider. ( 5.2 ) Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating EBGLYSS. If patients become infected while receiving EBGLYSS and do not respond to anti-helminth treatment, discontinue treatment with EBGLYSS until the infection resolves. ( 5.3 ) Vaccinations: Avoid use of live vaccines during treatment with EBGLYSS. ( 5.4 ) 5.1 Hypersensitivity Hypersensitivity reactions, including angioedema and urticaria, have been reported with use of EBGLYSS. If a serious hypersensitivity reaction occurs, discontinue EBGLYSS and institute appropriate therapy. 5.2 Conjunctivitis and Keratitis Conjunctivitis and keratitis adverse reactions have been reported in clinical trials. Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received EBGLYSS compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered during the treatment period [see Adverse Reactions ( 6.1 )] . Advise patients to report new onset or worsening eye symptoms to their healthcare provider. 5.3 Parasitic (Helminth) Infections Patients with known helminth infections were excluded from participation in clinical studies.

The following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions ( 5.1 )] Conjunctivitis and Keratitis [see Warnings and Precautions ( 5.2 )] Most common (≥1%) adverse reactions are conjunctivitis, injection site reactions, and herpes zoster. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Atopic Dermatitis The safety of EBGLYSS was evaluated across 4 randomized, double-blind, placebo-controlled, multicenter trials in subjects with moderate-to-severe atopic dermatitis including 3 phase 3 trials (ADvocate 1, ADvocate 2, ADhere) and 1 phase 2 dose ranging trial (KGAF). In these 4 trials, mean age was 37 years; 50% of subjects were male; 62% were White, 13% were Black, and 20% were Asian. In terms of co-morbid conditions, in the phase 3 trials, 30% of the subjects had asthma, 50% had allergic rhinitis, 31% had food allergy, and 14% had allergic conjunctivitis at baseline. A total of 891 subjects were treated with EBGLYSS for at least 1 year in the atopic dermatitis development program. ADvocate 1, ADvocate 2, and KGAF compared the safety of EBGLYSS monotherapy to placebo.

8.1 Pregnancy Risk Summary Available data on lebrikizumab-lbkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations) . In animal reproduction studies, no effects on embryo-fetal development were observed after subcutaneous administration of lebrikizumab-lbkz to cynomolgus monkeys during organogenesis at doses up to 18 times the human exposure at the maximum recommended human dose (MRHD) (see Data) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester. Therefore, EBGLYSS may be present in infants exposed in utero.

Metabolism

Lebrikizumab-lbkz steady-state exposure following either a subcutaneous dose of 250 mg every 2 weeks or every 4 weeks in patients with atopic dermatitis are presented in Table 2 . Lebrikizumab-lbkz exposure increases dose-proportionally over a subcutaneous dose range of 37.5 to 500 mg.

In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

• Sep 13, 2024BLABLA761306Eli Lilly And Co

1. 1Injection Site Pain14811%
2. 2Pruritus14210%
3. 3Drug Ineffective1218.8%
4. 4Rash1057.6%
5. 5Conjunctivitis977.0%
6. 6Dermatitis Atopic815.9%
7. 7Eczema785.7%
8. 8Erythema684.9%
9. 9Dry Skin473.4%
10. 10Urticaria453.3%
11. 11Condition Aggravated402.9%
12. 12Ocular Hyperaemia362.6%
13. 13Incorrect Dose Administered342.5%
14. 14Eye Pruritus312.2%
15. 15Hypersensitivity312.2%

The 10 most recently updated of 53 ClinicalTrials.gov registrations naming Lebrikizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
  Recruiting · Phase 3 · Interventional · 510 enrolled · Eli Lilly and Company
  NCT06338995updated 2026-06-03
• Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
  Not yet recruiting · Phase 2 · Interventional · 15 enrolled · University of Maryland, Baltimore
  NCT07620561updated 2026-06-02
• A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden
  Active not recruiting · Phase 4 · Interventional · 233 enrolled · Eli Lilly and Company
  NCT07006792updated 2026-05-22
• A Study of LAD106 in Healthy Adult Participants
  Recruiting · Phase 1 · Interventional · 93 enrolled · Almirall, S.A.
  NCT07471932updated 2026-05-15
• Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis
  Completed · Phase 3 · Interventional · 174 enrolled · Almirall, S.A.
  NCT05916365updated 2026-05-14
• A Study of Lebrikizumab in Adults With Nummular Eczema
  Not yet recruiting · Phase 3 · Interventional · 270 enrolled · Almirall, S.A.
  NCT07542483updated 2026-05-14
• A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
  Enrolling by invitation · Phase 3 · Interventional · 310 enrolled · Eli Lilly and Company
  NCT05735483updated 2026-05-06
• A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
  Active not recruiting · Phase 3 · Interventional · 520 enrolled · Almirall, S.A.
  NCT06526182updated 2026-04-21
• A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
  Recruiting · Phase 3 · Interventional · 450 enrolled · Eli Lilly and Company
  NCT06339008updated 2026-04-20

Frequently asked questions

How does Lebrikizumab work?

Lebrikizumab-lbkz is an IgG4 monoclonal antibody that binds with high affinity and slow off-rate to interleukin (IL)-13 and allows IL-13 to bind to IL-13Rα1 but inhibits human IL-13 signaling through the IL-4Rα/IL-13Rα1 receptor complex. IL-13 is a naturally occurring cytokine that is involved in Type 2 inflammation, which is an important component in the pathogenesis of atopic dermatitis.

What is Lebrikizumab used for?

According to FDA labeling, Lebrikizumab carries indications including: EBGLYSS is indicated for the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Lebrikizumab?

Lebrikizumab is classified as Agents for dermatitis, excluding corticosteroids, Interleukin-13 Antagonist, Interleukin-13 Antagonists, Decreased Cytokine Activity.

What are the brand names for Lebrikizumab?

Lebrikizumab is marketed under brand names including Ebglyss.

What are the contraindications for Lebrikizumab?

Lebrikizumab labeling lists contraindications including: EBGLYSS is contraindicated in patients with prior serious hypersensitivity to lebrikizumab-lbkz or any excipients of EBGLYSS [see Warnings and Precautions ( 5.1 )] . Prior serious hypersensitivity to lebrikizumab-lbkz or any excipients in EBGLYSS.. Always consult the full prescribing information and a clinician.