Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Tralokinumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03761537

LP0162-1346

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 severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).

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 to placebo in combination with TCS.

To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

Enrollment: 277 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 or more
• Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
• AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
• Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
• Subjects must have 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 TCSs are medically inadvisable in the opinion of the investigator
• Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
• Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
• Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
• Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
• History of any active skin infection within 1 week prior to randomisation
• History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
• A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
• Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
• History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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277 participants in 2 patient groups, including a placebo group

Tralokinumab + TCS

Experimental group

Description:

4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

Treatment:

Drug: Tralokinumab

Placebo + TCS

Placebo Comparator group

Description:

4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

Treatment:

Other: Placebo