Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA)

This is a single-arm, phase 3 trial designed to evaluate the efficacy and safety of tralokinumab when administered by an autoinjector in adults and adolescent subjects with moderate-to-severe AD. At baseline, the subjects will receive an initial SC dose of 600 mg tralokinumab. For the rest of the treatment period, all subjects will self-administer a dose of 300 mg tralokinumab every other week for 14 weeks.

Inclusion criteria

• Age 12 years and above.
• Subject able and willing to self-administer tralokinumab with Device A.
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
• History of AD for ≥1 year.
• A recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medication or for whom topical treatments are otherwise medically inadvisable.
• AD involvement of ≥10% body surface area at screening and baseline.
• An EASI score of ≥12 at screening and ≥16 at baseline.
• An IGA score of ≥3 at screening and at baseline.
• Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.

Exclusion criteria

• Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
• Use of tanning beds or phototherapy within 4 weeks prior to baseline.
• Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to baseline.
• Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to baseline.
• Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline.
• Active skin infections within 1 week prior to baseline.
• Clinically significant infection within 4 weeks prior to baseline.
• A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
• Tuberculosis requiring treatment within 12 months prior to screening.
• Known primary immunodeficiency disorder.