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

Phase 3

Completed

Brief Summary: The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Tralokinumab subcutaneous dosing by an autoinjector	Tralokinumab	An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.

Primary Outcome Measures

Name	Time	Method
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	At Week 16	IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16	At Week 16	Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition

Secondary Outcome Measures

Name	Time	Method
Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16	From Week 0 to Week 16	Serum samples for determination of presence or absence of ADA will be analysed using a validated bioanalytical method
Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16	From Week 0 to Week 16	An AE will be considered treatment emergent if it started after the first injection of trial drug