Tralokinumab Administered With Device A in Adults and Adolescents With Moderate-to-severe Atopic Dermatitis

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

Detailed Description
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This is a single-arm, phase 3 trial designed to evaluate the efficacy and safety of tralokinumab when administered with device A 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.

Official Title
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An Open-label, Single-arm, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Administered With Device A in Subjects With Moderate-to-severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Tralokinumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tralokinumab subcutaneous dosing with Device A<br>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. | Drug: Tralokinumab<br>* Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) 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 Week 16 | 
| At least 75% reduction in Eczema Area and Severity Index (EASI75) 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 | At Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent adverse events (AEs) from baseline to Week 16 | An AE will be considered treatment emergent if it started after the first injection of trial drug | From Week 0 to Week 16 | 
| Presence of treatment-emergent anti-drug antibodies (ADA) from baseline to Week 16 | Serum samples for determination of presence or absence of ADA will be analysed using a validated bioanalytical method | From Week 0 to Week 16 |