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

NCT05194540 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: LP0162-1338U1111-1283-2072
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 29

Brief Summary

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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16

  From Week 0 to Week 16

• Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16

  From Week 0 to Week 16

Study Arms (1)

Tralokinumab subcutaneous dosing by an autoinjector

EXPERIMENTAL

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

Interventions

Tralokinumab DRUG

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

Tralokinumab subcutaneous dosing by an autoinjector

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (29)

LEO Pharma Investigator

Birmingham, Alabama, 35205, United States

Location

LEO Pharma Investigator

Birmingham, Alabama, 35209, United States

Location

LEO Pharma Investigator

Fort Smith, Arkansas, 72916, United States

Location

LEO Pharma Investigator

Fountain Valley, California, 92708, United States

Location

LEO Pharma Investigator

Fremont, California, 94538, United States

Location

LEO Pharma Investigational Site

Inglewood, California, 90301, United States

Location

LEO Pharma Investigator

Los Angeles, California, 90025, United States

Location

LEO Pharma Investigator

San Diego, California, 92103, United States

Location

LEO Pharma Investigator

San Diego, California, 92130, United States

Location

LEO Pharma Investigator

Santa Ana, California, 92701, United States

Location

LEO Pharma Investigator

Centennial, Colorado, 80111, United States

Location

LEO Pharma Investigator

Farmington, Connecticut, 06032, United States

Location

LEO Pharma Investigational Site

Hialeah, Florida, 33012, United States

Location

LEO Pharma Investigator

Sanford, Florida, 32771, United States

Location

LEO Pharma Investigator

Libertyville, Illinois, 60048, United States

Location

LEO Pharma Investigator

Overland Park, Kansas, 66210, United States

Location

LEO Pharma Investigator

Bangor, Maine, 04401, United States

Location

LEO Pharma Investigator

Detroit, Michigan, 48202, United States

Location

LEO Pharma Investigator

Portsmouth, New Hampshire, 03801, United States

Location

LEO Pharma Investigator

Cortland, New York, 13045, United States

Location

LEO Pharma Investigator

Horseheads, New York, 14845, United States

Location

LEO Pharma Investigator

Bexley, Ohio, 43209, United States

Location

LEO Pharma Investigator

Toledo, Ohio, 43617, United States

Location

LEO Pharma Investigator

Tulsa, Oklahoma, 74136, United States

Location

LEO Pharma Investigator

Portland, Oregon, 97210, United States

Location

LEO Pharma Investigator

Dallas, Texas, 75225, United States

Location

LEO Pharma Investigator

Frisco, Texas, 75034, United States

Location

LEO Pharma Investigator

San Antonio, Texas, 78218, United States

Location

LEO Pharma Investigator

Webster, Texas, 77598, United States

Location

Related Publications (1)

• Soung J, Laquer V, Zirwas M, van Iperen P, Stinson JC, Albertsen KL, Stein Gold L. The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA). Dermatol Ther (Heidelb). 2025 Sep;15(9):2631-2644. doi: 10.1007/s13555-025-01490-3. Epub 2025 Jul 18.

  PMID: 40681936 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Disclosure
• Organization: Leo Pharma

disclosure@leo-pharma.com

+45 44945888

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: January 13, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 21, 2023
• Last Updated: March 11, 2025
• Results First Posted: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)