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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 : July 15, 2022
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 : 120 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 : January 6, 2023
Estimated Study Completion Date : May 8, 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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United States, Alabama
LEO Pharma Investigator Recruiting
Birmingham, Alabama, United States, 35205
Contact: LEO P Investigator         
LEO Pharma Investigator Recruiting
Birmingham, Alabama, United States, 35209
United States, Arkansas
LEO Pharma Investigator Recruiting
Fort Smith, Arkansas, United States, 72916
United States, California
LEO Pharma Investigator Recruiting
Fountain Valley, California, United States, 92708
LEO Pharma Investigator Recruiting
Fremont, California, United States, 94538
LEO Pharma Investigator Recruiting
Los Angeles, California, United States, 90025
LEO Pharma Investigator Recruiting
San Diego, California, United States, 92103
LEO Pharma Investigator Recruiting
San Diego, California, United States, 92130
LEO Pharma Investigator Recruiting
Santa Ana, California, United States, 92701
United States, Colorado
LEO Pharma Investigator Recruiting
Centennial, Colorado, United States, 80111
United States, Connecticut
LEO Pharma Investigator Recruiting
Farmington, Connecticut, United States, 06030
Contact: LEO P Investigator         
United States, Florida
LEO Pharma Investigator Recruiting
Sanford, Florida, United States, 32771
Contact: LEO P Investigator         
United States, Illinois
LEO Pharma Investigator Recruiting
Libertyville, Illinois, United States, 60048
Contact: LEO P Investigator         
United States, Kansas
LEO Pharma Investigator Recruiting
Overland Park, Kansas, United States, 66210
United States, Maine
LEO Pharma Investigator Recruiting
Bangor, Maine, United States, 04401
United States, Massachusetts
LEO Pharma Investigator Recruiting
Brighton, Massachusetts, United States, 02135
Contact: LEO P Investigator         
United States, Michigan
LEO Pharma Investigator Recruiting
Detroit, Michigan, United States, 48202
Contact: LEO P Investigator         
United States, Nebraska
LEO Pharma Investigator Recruiting
Omaha, Nebraska, United States, 68144
United States, New Hampshire
LEO Pharma Investigator Recruiting
Portsmouth, New Hampshire, United States, 03801
United States, New York
LEO Pharma Investigator Recruiting
Cortland, New York, United States, 13045
LEO Pharma Investigator Recruiting
Horseheads, New York, United States, 14845
United States, Ohio
LEO Pharma Investigator Recruiting
Bexley, Ohio, United States, 43209
LEO Pharma Investigator Recruiting
Toledo, Ohio, United States, 43617
United States, Oklahoma
LEO Pharma Investigator Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
LEO Pharma Investigator Recruiting
Portland, Oregon, United States, 97210
United States, Texas
LEO Pharma Investigator Recruiting
Dallas, Texas, United States, 75225
LEO Pharma Investigator Recruiting
Frisco, Texas, United States, 75034
LEO Pharma Investigator Recruiting
San Antonio, Texas, United States, 78218
LEO Pharma Investigator Recruiting
Webster, Texas, United States, 77598
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
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: January 2022
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