Clinical trial NCT04760314: A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab When Used in Combination With Topical Corticosteroid Treatment in Japanese Patients With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Keywords: Corticosteroids
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-02-18
Enrollment: 286
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving EASI-90 at Week 16
timeFrame: Week 16
measure: Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2
timeFrame: Baseline to Week 2
measure: Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Ainokawa, Ichikawa-shi
country: Japan
facility: Yanagihara dermatology clinic
state: Chiba
city: Ichikawa-shi
country: Japan
facility: Kawashima Dermatology Clinic
state: Chiba
city: Matsudo
country: Japan
facility: Charme Clinique
state: Chiba
city: Chikushino-city
country: Japan
facility: Yasumoto Dermatology Clinic
state: Fukuoka
city: Fukutsu
country: Japan
facility: Hino Dermatology Clinic
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima-ken
city: Obihiro
country: Japan
facility: Takagi Dermatology
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Kobayashi Skin Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Skin Clinic
state: Hokkaido
city: Kobe
country: Japan
facility: Dermatology Shimizu Clinic
state: Hyogo
city: Inashiki-gun
country: Japan
facility: Ibaraki Medical Center
state: Ibaraki
city: Nonoichi-shi
country: Japan
facility: KAJI Dermatology Clinic
state: Ishikawa
city: Kawasaki
country: Japan
facility: Kosugi Dermatology Clinic
state: Kanagawa
city: Nishi-ku, Yokohama-city
country: Japan
facility: Queen's Square Dermatology and Allergology
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Kashima-machi, Kamimashiki-gun
country: Japan
facility: Noguchi Dermatology
state: Kumamoto
city: Kumamoto Shi
country: Japan
facility: Jyouzanhihuka・Hinyoukika Clinic
state: Kumamoto
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Izumiotsu-shi
country: Japan
facility: Mochida Dermatology Clinic
state: Osaka
city: Sakai City
country: Japan
facility: Kume Clinic
state: Osaka
city: Takatsuki
country: Japan
facility: Yoshikawa Dermatology Clinic
state: Osaka
city: Ohmiya-ku,Saitama-shi
country: Japan
facility: Sanrui Dermatology Clinic
state: Saitama
city: Shimotsuga-Gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Akihabara Skin Clinic
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Sumire Dermatology Clinic
state: Tokyo
city: Koto-ku
country: Japan
facility: Maruyama Dermatology Clinic
state: Tokyo
city: Machida-shi
country: Japan
facility: Hamaguchi Skin Clinic
state: Tokyo
city: Minato-Ku
country: Japan
facility: Mita Dermatology Clinic
state: Tokyo
city: Ota-ku
country: Japan
facility: Tanpopo Dermatology Clinic
state: Tokyo
city: Shinjuku
country: Japan
facility: Yamate Dermatological Clinic
state: Tokyo
city: Sumida-ku
country: Japan
facility: Yoshihara Dermatology Clinic
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Tachikawa Dermatology Clinic
state: Tokyo
city: Takaoka-shi
country: Japan
facility: Shirasaki Clinic
state: Toyama
city: Fukuoka
country: Japan
facility: Matsuda Tomoko Dermatological Clinic
city: Kyoto-shi
country: Japan
facility: Kyoto Furitsu Medical University Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Goto Dermatology Clinic
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: