Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Tralokinumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03363854

LP0162-1339

2017-002065-21 (EudraCT Number)

Details and patient eligibility

About

Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to 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, and health-related quality of life 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 32 weeks.

Enrollment: 380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 and above.
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
• History of AD for ≥1 year.
• Subjects who have a recent history of inadequate response to treatment with topical medications.
• AD involvement of ≥10% body surface area at screening and baseline.
• Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

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.
• Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
• Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
• Treatment with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
• Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer prior to randomisation.
• Active skin infection 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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380 participants in 5 patient groups, including a placebo group

Tralokinumab(initial)responders-> Tralokinumab(continuation A)

Experimental group

Description:

Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.

Treatment:

Drug: Tralokinumab

Tralokinumab(initial)responders-> Tralokinumab(continuation B)

Experimental group

Description:

Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen B.

Treatment:

Drug: Tralokinumab

Tralokinumab(initial)non-respon-> Tralokinumab(continuation A)

Experimental group

Description:

Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.

Treatment:

Drug: Tralokinumab

Placebo (initial)non-respon-> Tralokinumab(continuation A)

Experimental group

Description:

Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.

Treatment:

Drug: Placebo

Drug: Tralokinumab

Placebo(initial)responders-> Placebo(continuation A)

Placebo Comparator group

Description:

Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 32 (continuation period): Placebo continuation SC injection regimen A.

Treatment:

Drug: Placebo