Tralokinumab Administered With Device A in Adults and Adolescents With Moderate-to-severe Atopic Dermatitis (INJECZTRA)
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|ClinicalTrials.gov Identifier: NCT05194540|
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : February 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Tralokinumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 13, 2022|
|Estimated Primary Completion Date :||July 24, 2023|
|Estimated Study Completion Date :||October 20, 2023|
Experimental: Tralokinumab subcutaneous dosing with Device A
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.
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
- Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16 [ Time Frame: 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 [ Time Frame: 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
- Number of treatment-emergent adverse events (AEs) from baseline to Week 16 [ Time Frame: From Week 0 to Week 16 ]An AE will be considered treatment emergent if it started after the first injection of trial drug
- Presence of treatment-emergent anti-drug antibodies (ADA) from baseline to Week 16 [ Time Frame: From Week 0 to Week 16 ]Serum samples for determination of presence or absence of ADA will be analysed using a validated bioanalytical method
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|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05194540
|Contact: Clinical Disclosure||(+1) firstname.lastname@example.org|
|Study Director:||Medical Expert||LEO Pharma|
|Responsible Party:||LEO Pharma|
|Other Study ID Numbers:||
U1111-1283-2072 ( Other Identifier: World Health Organization (WHO) )
|First Posted:||January 18, 2022 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||De-identified IPD can be made available to researchers in a closed environment for a specified period of time.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||Data is available to request after results of the trial are available on leopharmatrials.com|
|Access Criteria:||Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases