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

Atopic Dermatitis Clinical Trial

— INJECZTRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194540
• Other study ID #: LP0162-1338
• Secondary ID: U1111-1283-2072
• Status: Completed
• Phase: Phase 3
• Start date: January 13, 2022
• Est. completion date: June 21, 2023

Study information

• Verified date: June 2024
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 21, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.>

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	LEO Pharma Investigator	Bangor	Maine
United States	LEO Pharma Investigator	Bexley	Ohio
United States	LEO Pharma Investigator	Birmingham	Alabama
United States	LEO Pharma Investigator	Birmingham	Alabama
United States	LEO Pharma Investigator	Centennial	Colorado
United States	LEO Pharma Investigator	Cortland	New York
United States	LEO Pharma Investigator	Dallas	Texas
United States	LEO Pharma Investigator	Detroit	Michigan
United States	LEO Pharma Investigator	Farmington	Connecticut
United States	LEO Pharma Investigator	Fort Smith	Arkansas
United States	LEO Pharma Investigator	Fountain Valley	California
United States	LEO Pharma Investigator	Fremont	California
United States	LEO Pharma Investigator	Frisco	Texas
United States	LEO Pharma Investigational Site	Hialeah	Florida
United States	LEO Pharma Investigator	Horseheads	New York
United States	LEO Pharma Investigational Site	Inglewood	California
United States	LEO Pharma Investigator	Libertyville	Illinois
United States	LEO Pharma Investigator	Los Angeles	California
United States	LEO Pharma Investigator	Overland Park	Kansas
United States	LEO Pharma Investigator	Portland	Oregon
United States	LEO Pharma Investigator	Portsmouth	New Hampshire
United States	LEO Pharma Investigator	San Antonio	Texas
United States	LEO Pharma Investigator	San Diego	California
United States	LEO Pharma Investigator	San Diego	California
United States	LEO Pharma Investigator	Sanford	Florida
United States	LEO Pharma Investigator	Santa Ana	California
United States	LEO Pharma Investigator	Toledo	Ohio
United States	LEO Pharma Investigator	Tulsa	Oklahoma
United States	LEO Pharma Investigator	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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