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Trial record 1 of 6 for:    tralokinumab | Recruiting, Not yet recruiting Studies | Atopic Dermatitis
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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
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tralokinumab Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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.
Drug: Tralokinumab
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




Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Clinical Disclosure (+1) 877-557-1168 clinicaltrialscontactus@leo-pharma.com

Locations
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Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT05194540    
Other Study ID Numbers: LP0162-1338
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.
Supporting Materials: Study Protocol
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.
URL: http://leopharmatrials.com/en

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases