A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis (ADhere-J)

Lilly

Status and phase: Completed; Phase 3

Conditions: Dermatitis, Atopic; Dermatitis; Skin Diseases; Eczema; Skin Diseases, Genetic

Treatments: Drug: Placebo; Drug: Topical Corticosteroid; Drug: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04760314

17953

J2T-JE-KGAL (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis.

Enrollment: 286 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have chronic Atopic Dermatitis (AD) that has been present for ≥1 year before the screening.

• Have moderate-to-severe AD, including all of the following:

  • EASI score ≥16 at the baseline
  • IGA score ≥3 (scale of 0 to 4) at the baseline
  • AD involvement on ≥10% of Body Surface Area (BSA) at the baseline

• Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:

  • Inability to achieve good disease control, defined as mild disease or better (for example, IGA ≤2) after use of at least a medium-potency topical corticosteroids (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent TCS), whichever is shorter. Topical corticosteroids may be used with or without Topical calcineurin inhibitors (TCI) and/or topical Janus Kinase (JAK) inhibitors.
  • Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and mycophenolate mofetil (MMF), will also be considered as surrogates for having inadequate response to topical therapy.

• Body weight ≥40 kilogram (kg)

Exclusion criteria

• Have a history of anaphylaxis
• Have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for >24 hours at baseline.
• Have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline.
• Evidence of acute or chronic hepatitis or known liver cirrhosis.
• Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at screening and a confirmed diagnosis of PCP.
• Have a history of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments.
• Have presence of significant uncontrolled neuropsychiatric disorder.
• Have been exposed to a live vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 3 patient groups, including a placebo group

Lebrikizumab 250 mg Every 4 weeks (Q4W)

Experimental group

Description:

Participants received 500 mg of Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12, in combination with topical corticosteroid. Week 16 responders entered maintenance period and continued with the same treatment. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.

Treatment:

Drug: Topical Corticosteroid

Drug: Lebrikizumab

Lebrikizumab 250 mg Every 2 weeks (Q2W)

Experimental group

Description:

Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14, in combination with topical corticosteroid. Week 16 responders entered maintenance period and were randomly allocated to receive 250 mg lebrikizumab Q2W or 250 mg lebrikizumab Q4W, in a 1:1 ratio. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.

Treatment:

Drug: Topical Corticosteroid

Drug: Lebrikizumab

Placebo

Placebo Comparator group

Description:

Participants received two SC injections of Placebo as a loading dose at Baseline in combination with topical corticosteroid and Week 2 followed by a single injection Q2W from Week 4 until Week 14. Week 16 responders entered maintenance period and continued with the same treatment. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.

Treatment:

Drug: Topical Corticosteroid

Drug: Placebo