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

Phase 3
Completed
Conditions
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Eczema
Interventions
Drug: Lebrikizumab
Drug: Placebo
Drug: Topical Corticosteroid
Registration Number
NCT04760314
Lead Sponsor
Eli Lilly and Company
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
286
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)

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lebrikizumab 250 mg Every 4 weeks (Q4W)LebrikizumabParticipants 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.
Lebrikizumab 250 mg Every 2 weeks (Q2W)LebrikizumabParticipants 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.
PlaceboPlaceboParticipants 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.
PlaceboTopical CorticosteroidParticipants 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.
Lebrikizumab 250 mg Every 4 weeks (Q4W)Topical CorticosteroidParticipants 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.
Lebrikizumab 250 mg Every 2 weeks (Q2W)Topical CorticosteroidParticipants 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.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16Baseline to Week 16

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16Week 16

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).

The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

Secondary Outcome Measures
NameTimeMethod
Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16Baseline to Week 16

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).

Least Square (LS) Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.

Percentage of Participants Achieving EASI-90 at Week 16Week 16

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).

The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.

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 1Baseline to Week 1

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16Baseline to Week 16

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2Baseline to Week 2

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4Baseline to Week 4

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Trial Locations

Locations (37)

Hiroshima University Hospital

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Hiroshima-shi, Hiroshima-ken, Japan

KAJI Dermatology Clinic

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Nonoichi-shi, Ishikawa, Japan

Kosugi Dermatology Clinic

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Kawasaki, Kanagawa, Japan

Charme Clinique

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Matsudo, Chiba, Japan

Hino Dermatology Clinic

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Fukutsu, Fukuoka, Japan

Dermatology Shimizu Clinic

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Kobe, Hyogo, Japan

Mochida Dermatology Clinic

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Izumiotsu-shi, Osaka, Japan

Goto Dermatology Clinic

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Osaka, Japan

Akihabara Skin Clinic

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Chiyoda-ku, Tokyo, Japan

Yasumoto Dermatology Clinic

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Chikushino-city, Fukuoka, Japan

Takagi Dermatology

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Obihiro, Hokkaido, Japan

Ibaraki Medical Center

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Inashiki-gun, Ibaraki, Japan

Jyouzanhihuka・Hinyoukika Clinic

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Kumamoto Shi, Kumamoto, Japan

Osaka Habikino Medical Center

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Habikino, Osaka, Japan

Sanrui Dermatology Clinic

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Ohmiya-ku,Saitama-shi, Saitama, Japan

Dokkyo Medical University Hospital

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Shimotsuga-Gun, Tochigi, Japan

Yamate Dermatological Clinic

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Shinjuku, Tokyo, Japan

Kawashima Dermatology Clinic

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Ichikawa-shi, Chiba, Japan

Sapporo Skin Clinic

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Sapporo, Hokkaido, Japan

Kume Clinic

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Sakai City, Osaka, Japan

Matsuda Tomoko Dermatological Clinic

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Fukuoka, Japan

Osaka City University Hospital

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Osaka, Japan

Yoshihara Dermatology Clinic

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Sumida-ku, Tokyo, Japan

Yanagihara dermatology clinic

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Ainokawa, Ichikawa-shi, Chiba, Japan

Nomura Dermatology Clinic

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Yokohama-shi, Kanagawa, Japan

Tachikawa Dermatology Clinic

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Tachikawa-shi, Tokyo, Japan

Sumire Dermatology Clinic

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Edogawa-ku, Tokyo, Japan

Kobayashi Skin Clinic

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Sapporo-shi, Hokkaido, Japan

Queen's Square Dermatology and Allergology

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Nishi-ku, Yokohama-city, Kanagawa, Japan

Noguchi Dermatology

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Kashima-machi, Kamimashiki-gun, Kumamoto, Japan

Yoshikawa Dermatology Clinic

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Takatsuki, Osaka, Japan

Maruyama Dermatology Clinic

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Koto-ku, Tokyo, Japan

Mita Dermatology Clinic

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Minato-Ku, Tokyo, Japan

Hamaguchi Skin Clinic

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Machida-shi, Tokyo, Japan

Tanpopo Dermatology Clinic

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Ota-ku, Tokyo, Japan

Shirasaki Clinic

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Takaoka-shi, Toyama, Japan

Kyoto Furitsu Medical University Hospital

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Kyoto-shi, Japan

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