Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis (ECZTRA 8)

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Tralokinumab; Other: Topical corticosteroids (TCS); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04587453

LP0162-1343

Details and patient eligibility

About

Primary objective:

To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS.

To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 16 weeks.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

• Japanese subject aged 18 years and above.
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
• History of AD for 1 year or more.
• A recent history (within 1 year before screening) of inadequate response to treatment with topical medication.
• AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD.
• Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

Key exclusion criteria:

• Subjects for whom TCS are medically inadvisable e.g. due to important side effects or safety risks in the opinion of the investigator.
• Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
• Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
• Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to randomisation.
• Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.
• Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation.
• Active skin infections within 1 week prior to randomisation.
• Clinically significant infection within 4 weeks prior to randomisation.
• A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
• Tuberculosis requiring treatment within the 12 months prior to screening.
• Known primary immunodeficiency disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Tralokinumab+TCS

Experimental group

Description:

Week 0 to Week 16: Tralokinumab will be given as subcutaneous injections. Participants will receive tralokinumab loading dose on Day 0 followed by multiple tralokinumab injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.

Treatment:

Other: Topical corticosteroids (TCS)

Drug: Tralokinumab

Placebo+TCS

Placebo Comparator group

Description:

Week 0 to Week 16: Placebo will be given as subcutaneous injections. Participants will receive placebo loading dose on Day 0 followed by multiple placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.

Treatment:

Drug: Placebo

Other: Topical corticosteroids (TCS)