Clinical trial NCT05194540: Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2022-01-18
Enrollment: 136
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
timeFrame: At Week 16
measure: At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16
timeFrame: From Week 0 to Week 16
measure: Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
timeFrame: From Week 0 to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: LEO Pharma Investigator
state: Alabama
city: Birmingham
country: United States
facility: LEO Pharma Investigator
state: Alabama
city: Fort Smith
country: United States
facility: LEO Pharma Investigator
state: Arkansas
city: Fountain Valley
country: United States
facility: LEO Pharma Investigator
state: California
city: Fremont
country: United States
facility: LEO Pharma Investigator
state: California
city: Inglewood
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: LEO Pharma Investigator
state: California
city: San Diego
country: United States
facility: LEO Pharma Investigator
state: California
city: San Diego
country: United States
facility: LEO Pharma Investigator
state: California
city: Santa Ana
country: United States
facility: LEO Pharma Investigator
state: California
city: Centennial
country: United States
facility: LEO Pharma Investigator
state: Colorado
city: Farmington
country: United States
facility: LEO Pharma Investigator
state: Connecticut
city: Hialeah
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Sanford
country: United States
facility: LEO Pharma Investigator
state: Florida
city: Libertyville
country: United States
facility: LEO Pharma Investigator
state: Illinois
city: Overland Park
country: United States
facility: LEO Pharma Investigator
state: Kansas
city: Bangor
country: United States
facility: LEO Pharma Investigator
state: Maine
city: Detroit
country: United States
facility: LEO Pharma Investigator
state: Michigan
city: Portsmouth
country: United States
facility: LEO Pharma Investigator
state: New Hampshire
city: Cortland
country: United States
facility: LEO Pharma Investigator
state: New York
city: Horseheads
country: United States
facility: LEO Pharma Investigator
state: New York
city: Bexley
country: United States
facility: LEO Pharma Investigator
state: Ohio
city: Toledo
country: United States
facility: LEO Pharma Investigator
state: Ohio
city: Tulsa
country: United States
facility: LEO Pharma Investigator
state: Oklahoma
city: Portland
country: United States
facility: LEO Pharma Investigator
state: Oregon
city: Dallas
country: United States
facility: LEO Pharma Investigator
state: Texas
city: Frisco
country: United States
facility: LEO Pharma Investigator
state: Texas
city: San Antonio
country: United States
facility: LEO Pharma Investigator
state: Texas
city: Webster
country: United States
facility: LEO Pharma Investigator
state: Texas
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: