Tralokinumab Administered With Device A in Adults and Adolescents With Moderate-to-severe Atopic Dermatitis

• Status: Not yet recruiting
• Trial end date: 2023-01-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection with Device A in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

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.