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

JRCT ID: jRCT2031200389

Registered date:01/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 10/03/2021
• Target sample size: 280
• Study type: Interventional

Intervention(s)

Lebrikizumab Regimen A subcutaneous (SC)injection + Topical Corticosteroids (TCS)
Lebrikizumab Regimen B SC injection + TCS
Placebo SC injection + TCS

Outcome(s)

Primary Outcome

1.Percentage of Participants with an Investigators Global Assessment (IGA) score of 0 or 1 and a reduction >=2 points from Baseline to Week 16
Percentage of participants with an IGA score of 0 or 1 and a reduction >=2 points from Baseline to Week 16
[Time Frame: Baseline to Week 16]
2.Percentage of Participants achieving Eczema Area Severity Index-75 (EASI-75) (>=75% reduction in EASI score) from Baseline to Week 16
Percentage of Participants achieving EASI-75 (>=75% reduction in EASI score) from Baseline to Week 16
[Time Frame: Baseline to Week 16]

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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 Inhibitor (TCIs) 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)

Exclude 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, antiparasitic, 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 the baseline visit or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT04760314