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

(INJECZTRA Trial)

Recruiting at 30 trial locations

Overseen By Clinical Disclosure

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: LEO Pharma

Must not be taking: Immunosuppressives, Corticosteroids, Biologics, others

Disqualifiers: Active skin infections, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

136 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if tralokinumab injections can safely and effectively treat moderate-to-severe atopic dermatitis in people aged 12 and older. The medication works by reducing skin inflammation through blocking a specific protein. Tralokinumab has been evaluated for its efficacy and safety in treating moderate-to-severe atopic dermatitis.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting. You must not use systemic immunosuppressive drugs, systemic corticosteroids, or certain topical treatments for a specified period before the trial begins.

Research Team

Medical Expert

Principal Investigator

LEO Pharma

Eligibility Criteria

Inclusion Criteria

Age 12 years and above

Subject able and willing to self-administer tralokinumab with Device A

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

Exclusion Criteria

Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an initial SC dose of 600 mg tralokinumab at baseline, followed by 300 mg every other week for 14 weeks

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Tralokinumab

Participant Groups

Group I: Tralokinumab subcutaneous dosing by an autoinjector Experimental Treatment 1 Intervention

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.

Tralokinumab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Adbry for:

• Moderate-to-severe atopic dermatitis

Approved in European Union as Adtralza for:

• Moderate-to-severe atopic dermatitis

Approved in Canada as Adtralza for:

• Moderate-to-severe atopic dermatitis

Who Is Running the Clinical Trial?

LEO Pharma

Lead Sponsor

Trials

275

Recruited

189,000+

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD