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

An Open-label, Single-arm, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Subjects With Moderate-to-severe Atopic Dermatitis

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Tralokinumab

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • LEO Pharma Investigator
    • Birmingham, Alabama, United States, 35209
      • LEO Pharma Investigator
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • LEO Pharma Investigator
  • California
    • Fountain Valley, California, United States, 92708
      • LEO Pharma Investigator
    • Fremont, California, United States, 94538
      • LEO Pharma Investigator
    • Inglewood, California, United States, 90301
      • LEO Pharma Investigational Site
    • Los Angeles, California, United States, 90025
      • LEO Pharma Investigator
    • San Diego, California, United States, 92103
      • LEO Pharma Investigator
    • San Diego, California, United States, 92130
      • LEO Pharma Investigator
    • Santa Ana, California, United States, 92701
      • LEO Pharma Investigator
  • Colorado
    • Centennial, Colorado, United States, 80111
      • LEO Pharma Investigator
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • LEO Pharma Investigator
  • Florida
    • Hialeah, Florida, United States, 33012
      • LEO Pharma Investigational Site
    • Sanford, Florida, United States, 32771
      • LEO Pharma Investigator
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • LEO Pharma Investigator
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • LEO Pharma Investigator
  • Maine
    • Bangor, Maine, United States, 04401
      • LEO Pharma Investigator
  • Michigan
    • Detroit, Michigan, United States, 48202
      • LEO Pharma Investigator
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • LEO Pharma Investigator
  • New York
    • Cortland, New York, United States, 13045
      • LEO Pharma Investigator
    • Horseheads, New York, United States, 14845
      • LEO Pharma Investigator
  • Ohio
    • Bexley, Ohio, United States, 43209
      • LEO Pharma Investigator
    • Toledo, Ohio, United States, 43617
      • LEO Pharma Investigator
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • LEO Pharma Investigator
  • Oregon
    • Portland, Oregon, United States, 97210
      • LEO Pharma Investigator
  • Texas
    • Dallas, Texas, United States, 75225
      • LEO Pharma Investigator
    • Frisco, Texas, United States, 75034
      • LEO Pharma Investigator
    • San Antonio, Texas, United States, 78218
      • LEO Pharma Investigator
    • Webster, Texas, United States, 77598
      • LEO Pharma Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tralokinumab subcutaneous dosing by an autoinjector; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): June 6, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: LP0162-1338; U1111-1283-2072 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No