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

Inclusion Criteria:

• Age 6 months to <12 years at screening.

• Body weight ≥9 kg at screening.

• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.

• History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 monthsfor subjects aged 6 months to <6 years at screening.

• Documented inadequate response to mid-strength TCS within 6 months before thescreening visit.

• AD involvement of ≥10% body surface area at screening and baseline according tocomponent A of SCORAD.

• An EASI score of ≥16 at screening and baseline.

• An IGA score of ≥3 at screening and baseline.

• A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) ora Scratch ObsRO average score of ≥4 (subjects aged <6 years at screening) during theweek prior to baseline.

Exclusion Criteria:

• Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinaseinhibitors (JAK) within 1 week prior to baseline.

• Treatment with bleach baths within 1 week prior to baseline.

• Treatment with the immunomodulatory medications systemicimmunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine,azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemiccorticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4weeks prior to baseline.

• Use of tanning beds or phototherapy within 4 weeks prior to baseline.

• Treatment with a live (attenuated) or non-live vaccine within 30 days prior to thebaseline visit.

• Active dermatologic conditions that may confound the diagnosis of AD or wouldinterfere with assessment of treatment such as seborrheic dermatitis, active skininfection, scabies, cutaneous T cell lymphoma, or psoriasis.

• Clinically significant active chronic or acute infection requiring treatment withsystemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks beforethe baseline visit.

• History of past or current hepatitis B or C including a positive hepatitis B or Ctest at screening.