Back to resultsA Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis (ADhere-J)
Primary Purpose
Dermatitis, Atopic, Dermatitis, Eczema
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Lebrikizumab
Placebo
Topical Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Corticosteroids
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.
Sites / Locations
- Yanagihara dermatology clinic
- Kawashima Dermatology Clinic
- Charme Clinique
- Yasumoto Dermatology Clinic
- Hino Dermatology Clinic
- Hiroshima University Hospital
- Takagi Dermatology
- Kobayashi Skin Clinic
- Sapporo Skin Clinic
- Dermatology Shimizu Clinic
- Ibaraki Medical Center
- KAJI Dermatology Clinic
- Kosugi Dermatology Clinic
- Queen's Square Dermatology and Allergology
- Nomura Dermatology Clinic
- Noguchi Dermatology
- Jyouzanhihuka・Hinyoukika Clinic
- Osaka Habikino Medical Center
- Mochida Dermatology Clinic
- Kume Clinic
- Yoshikawa Dermatology Clinic
- Sanrui Dermatology Clinic
- Dokkyo Medical University Hospital
- Akihabara Skin Clinic
- Sumire Dermatology Clinic
- Maruyama Dermatology Clinic
- Hamaguchi Skin Clinic
- Mita Dermatology Clinic
- Tanpopo Dermatology Clinic
- Yamate Dermatological Clinic
- Yoshihara Dermatology Clinic
- Tachikawa Dermatology Clinic
- Shirasaki Clinic
- Matsuda Tomoko Dermatological Clinic
- Kyoto Furitsu Medical University Hospital
- Osaka City University Hospital
- Goto Dermatology Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Lebrikizumab 250 mg Every 4 weeks (Q4W)
Lebrikizumab 250 mg Every 2 weeks (Q2W)
Placebo
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline 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 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
Percent Change in Eczema Area Severity Index (EASI) Score From Baseline 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 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 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 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 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."
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline 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."
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04760314
Brief Title
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis
Acronym
ADhere-J
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Skin Diseases, Genetic
Keywords
Corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lebrikizumab 250 mg Every 4 weeks (Q4W)
Arm Type
Experimental
Arm 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.
Arm Title
Lebrikizumab 250 mg Every 2 weeks (Q2W)
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lebrikizumab
Other Intervention Name(s)
LY3650150
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Topical Corticosteroid
Intervention Description
Self-applied
Primary Outcome Measure Information:
Title
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
Description
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.
Time Frame
Baseline to Week 16
Title
Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16
Description
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.
Time Frame
Baseline to Week 16
Title
Percentage of Participants Achieving EASI-90 at Week 16
Description
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.
Time Frame
Week 16
Title
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
Description
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."
Time Frame
Baseline to Week 1
Title
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2
Description
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."
Time Frame
Baseline to Week 2
Title
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4
Description
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."
Time Frame
Baseline to Week 4
Title
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16
Description
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."
Time Frame
Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Yanagihara dermatology clinic
City
Ainokawa, Ichikawa-shi
State/Province
Chiba
ZIP/Postal Code
272-0143
Country
Japan
Facility Name
Kawashima Dermatology Clinic
City
Ichikawa-shi
State/Province
Chiba
ZIP/Postal Code
272-0033
Country
Japan
Facility Name
Charme Clinique
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2223
Country
Japan
Facility Name
Yasumoto Dermatology Clinic
City
Chikushino-city
State/Province
Fukuoka
ZIP/Postal Code
818-0083
Country
Japan
Facility Name
Hino Dermatology Clinic
City
Fukutsu
State/Province
Fukuoka
ZIP/Postal Code
811-3217
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
State/Province
Hiroshima-ken
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Takagi Dermatology
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Kobayashi Skin Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0807
Country
Japan
Facility Name
Sapporo Skin Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Dermatology Shimizu Clinic
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
657-0846
Country
Japan
Facility Name
Ibaraki Medical Center
City
Inashiki-gun
State/Province
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
Facility Name
KAJI Dermatology Clinic
City
Nonoichi-shi
State/Province
Ishikawa
ZIP/Postal Code
921-8801
Country
Japan
Facility Name
Kosugi Dermatology Clinic
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-0063
Country
Japan
Facility Name
Queen's Square Dermatology and Allergology
City
Nishi-ku, Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
220-6208
Country
Japan
Facility Name
Nomura Dermatology Clinic
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Noguchi Dermatology
City
Kashima-machi, Kamimashiki-gun
State/Province
Kumamoto
ZIP/Postal Code
861-3101
Country
Japan
Facility Name
Jyouzanhihuka・Hinyoukika Clinic
City
Kumamoto Shi
State/Province
Kumamoto
ZIP/Postal Code
860-0066
Country
Japan
Facility Name
Osaka Habikino Medical Center
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Mochida Dermatology Clinic
City
Izumiotsu-shi
State/Province
Osaka
ZIP/Postal Code
595-0025
Country
Japan
Facility Name
Kume Clinic
City
Sakai City
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Yoshikawa Dermatology Clinic
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-0824
Country
Japan
Facility Name
Sanrui Dermatology Clinic
City
Ohmiya-ku,Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330-0854
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-Gun
State/Province
Tochigi
ZIP/Postal Code
321 0293
Country
Japan
Facility Name
Akihabara Skin Clinic
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-0021
Country
Japan
Facility Name
Sumire Dermatology Clinic
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
133-0057
Country
Japan
Facility Name
Maruyama Dermatology Clinic
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Facility Name
Hamaguchi Skin Clinic
City
Machida-shi
State/Province
Tokyo
ZIP/Postal Code
194-0013
Country
Japan
Facility Name
Mita Dermatology Clinic
City
Minato-Ku
State/Province
Tokyo
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
Tanpopo Dermatology Clinic
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
Yamate Dermatological Clinic
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
169-0075
Country
Japan
Facility Name
Yoshihara Dermatology Clinic
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-0014
Country
Japan
Facility Name
Tachikawa Dermatology Clinic
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
190-0023
Country
Japan
Facility Name
Shirasaki Clinic
City
Takaoka-shi
State/Province
Toyama
ZIP/Postal Code
9330871
Country
Japan
Facility Name
Matsuda Tomoko Dermatological Clinic
City
Fukuoka
ZIP/Postal Code
819-0167
Country
Japan
Facility Name
Kyoto Furitsu Medical University Hospital
City
Kyoto-shi
ZIP/Postal Code
602 8566
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Goto Dermatology Clinic
City
Osaka
ZIP/Postal Code
554-0021
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/6Snw910hnAdavPQabysPCL
Description
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis (ADhere-J)
Learn more about this trial
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis
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