Tralokinumab

Tralokinumab-ldrm is a human IgG4 monoclonal antibody that specifically binds to human interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). IL-13 is a naturally occurring cytokine of the Type 2 immune response.

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

• ADBRY is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY [see Warnings and Precautions (5.1) ] . Known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.contraindicated

Prior to ADBRY initiation, complete all age appropriate vaccinations as recommended by current immunization guidelines ( 2.1 ) Administer ADBRY by subcutaneous injection. ( 2.2 ) In pediatric patients 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult. ( 2.2 ) The recommended dosage of ADBRY ( 2.3 ) Dosage in Adults Initial Loading Dose Subsequent Dosage Prefilled syringe 600 mg (four 150 mg injections) 300 mg (two 150 mg injections) every other week Autoinjector 600 mg (two 300 mg injections) 300 mg (one 300 mg injection) every other week Dosage in Pediatric Patients 12 Years of Age and Older Initial Loading Dose Subsequent Dosage Prefilled syringe 300 mg (two 150 mg injections) 150 mg (one 150 mg injection) every other week A dosage of 300 mg every 4 weeks may be considered for adult patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment. ( 2.3 ) 2.1 Vaccination Prior to Treatment Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with ADBRY [see Warnings and Precautions (5.4) ] . 2.2 Important Administration Instructions ADBRY is administered by subcutaneous injection. ADBRY is intended for use under the guidance of a healthcare provider. Provide proper training to patients and/or caregivers on the preparation and administration of ADBRY prior to use according to the "Instructions for Use" [see Instructions for Use ] . Use of the Autoinjector The ADBRY autoinjector is for use in adults only.

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, and angioedema have occurred after administration of ADBRY. Discontinue ADBRY in the event of a hypersensitivity reaction. ( 5.1 ) Conjunctivitis and Keratitis: Patients should report new onset or worsening eye symptoms to their healthcare provider. ( 5.2 ) Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating treatment with ADBRY. If patients become infected while receiving ADBRY and do not respond to anti-helminth treatment, discontinue treatment with ADBRY until the infection resolves. ( 5.3 ) Risk of Infection with Live Vaccines: Avoid use of live vaccines. ( 5.4 ) 5.1 Hypersensitivity Hypersensitivity reactions including anaphylaxis and angioedema have been reported with use of ADBRY. If a serious hypersensitivity reaction occurs, discontinue ADBRY immediately and initiate appropriate therapy. 5.2 Conjunctivitis and Keratitis Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received ADBRY. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering 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 discussed in greater detail elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Conjunctivitis and Keratitis [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥ 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 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 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. Adverse Reactions from Clinical Trials in Adults The safety of ADBRY was evaluated in a pool of 5 randomized, double-blind, placebo-controlled trials in subjects with moderate-to-severe atopic dermatitis including three phase 3 Eczema Tralokinumab trials (ECZTRA 1, ECZTRA 2, and ECZTRA 3), a dose-finding trial, and a vaccine response trial. The safety population had a mean age of 37 years; 43% of subjects were female, 67% were White, 21% were Asian, and 9% were Black. In terms of co-morbid conditions, 39% of the subjects had asthma, 49% had hay fever, 36% had food allergy, and 21% had allergic conjunctivitis at baseline. In these 5 atopic dermatitis trials, 1964 subjects were treated with subcutaneous injections of ADBRY, with or without concomitant topical corticosteroids (TCS).

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADBRY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. Risk Summary There are limited data from the use of ADBRY in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations ) . In an enhanced pre-and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after intravenous administration of tralokinumab-ldrm during organogenesis through parturition at doses up to 10 times the maximum recommended human dose (MRHD). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. 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.

Metabolism

In adults, the mean (SD) steady-state trough concentration of tralokinumab-ldrm ranged from 98.0 (41.1) mcg/mL to 101.4 (42.7) mcg/mL following administration of ADBRY at 300 mg every other week. Tralokinumab-ldrm exposure increased proportionally over a dosage range up to 2100 mg for a 70 kg subject (30 mg/kg IV) (3.5 times the maximum approved recommended dosage).

There is no specific treatment for ADBRY overdose. In the event of overdosage, contact Poison Control (1-800-222-1222) for latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

• Dec 27, 2021BLABLA761180Leo Pharma As

1. 1Dermatitis Atopic78214%
2. 2Drug Ineffective72313%
3. 3Pruritus60111%
4. 4Rash4287.7%
5. 5Injection Site Pain3085.6%
6. 6Eczema2845.1%
7. 7Dry Skin2394.3%
8. 8Erythema1923.5%
9. 9Injection Site Erythema1803.3%
10. 10Injection Site Pruritus1622.9%
11. 11Product Use In Unapproved Indication1572.8%
12. 12Injection Site Swelling1512.7%
13. 13Ocular Hyperaemia1492.7%
14. 14Eye Pruritus1482.7%
15. 15Arthralgia1462.6%

The 10 most recently updated of 45 ClinicalTrials.gov registrations naming Tralokinumab 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
• Tralokinumab for Dupilumab Failures
  Terminated · Phase 4 · Interventional · 7 enrolled · Psoriasis Treatment Center of Central New Jersey
  NCT06773455updated 2026-05-22
• Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
  Completed · Phase 2 · Interventional · 28 enrolled · LEO Pharma
  NCT05388760updated 2026-05-14
• Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
  Recruiting · Observational · 15 enrolled · Hôpitaux Drôme Nord
  NCT07568665updated 2026-05-06
• Ophthalmological Adverse Events of Tralokinumab in AD
  Completed · Observational · 100 enrolled · Nantes University Hospital
  NCT05682976updated 2026-05-01
• A Trial to Compare the Pharmacokinetics of Tralokinumab in Healthy Subjects
  Completed · Phase 1 · Interventional · 101 enrolled · LEO Pharma
  NCT04674826updated 2026-04-24
• Registry for Systemic Eczema Treatments
  Recruiting · Observational · 400 enrolled · Johns Hopkins University
  NCT06136767updated 2026-04-07
• A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis
  Recruiting · Phase 3 · Interventional · 195 enrolled · LEO Pharma
  NCT06311682updated 2026-03-20
• Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
  Recruiting · Observational · 30 enrolled · University Hospital Schleswig-Holstein
  NCT07444801updated 2026-03-03
• Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation
  Terminated · Phase 2 · Phase 3 · Interventional · 24 enrolled · University of Zurich
  NCT05378698updated 2026-02-06

Frequently asked questions

How does Tralokinumab work?

Tralokinumab-ldrm is a human IgG4 monoclonal antibody that specifically binds to human interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). IL-13 is a naturally occurring cytokine of the Type 2 immune response.

What is Tralokinumab used for?

According to FDA labeling, Tralokinumab carries indications including: ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY 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 Tralokinumab?

Tralokinumab is classified as Agents for dermatitis, excluding corticosteroids, Interleukin-13 Antagonist, Interleukin-13 Antagonists.

What are the brand names for Tralokinumab?

Tralokinumab is marketed under brand names including Adbry.

What are the contraindications for Tralokinumab?

Tralokinumab labeling lists contraindications including: ADBRY is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY [see Warnings and Precautions (5.1) ] . Known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.. Always consult the full prescribing information and a clinician.