Dermatitis, AtopicPhase 3ADhere-JNCT04760314

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

A Phase 3 study testing Lebrikizumab and Topical Corticosteroid in people with Dermatitis, Atopic and Dermatitis, run by Eli Lilly and Company at 37 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Dermatitis, Atopic, Dermatitis, Eczema
What is being tested?: Lebrikizumab and Topical Corticosteroid
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 286 participants
Where: 37 sitesJapan
Study dates: 10 Mar 2021to 1 Feb 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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:

Show all 9Show fewer

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)

Who cannot join

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.

Show all 9Show fewer

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 locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

Japan37 sites

Yanagihara dermatology clinic
Ainokawa, Ichikawa-shi, Chiba, 272-0143
Yasumoto Dermatology Clinic
Chikushino-shi, Fukuoka, 818-0083
Akihabara Skin Clinic
Chiyoda-ku, Tokyo, 101-0021
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, 133-0057
Matsuda Tomoko Dermatological Clinic
Fukuoka, 819-0167
Hino Dermatology Clinic
Fukutsu, Fukuoka, 811-3217
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Kawashima Dermatology Clinic
Ichikawa-shi, Chiba, 272-0033
Ibaraki Medical Center
Inashiki-gun, Ibaraki, 300-0395
Mochida Dermatology Clinic
Izumiotsu-shi, Osaka, 595-0025
Noguchi Dermatology
Kashima-machi, Kamimashiki-gun, Kumamoto, 861-3101
Kosugi Dermatology Clinic
Kawasaki, Kanagawa, 211-0063
Dermatology Shimizu Clinic
Kobe, Hyōgo, 657-0846
Maruyama Dermatology Clinic
Koto-ku, Tokyo, 136-0074
Jyouzanhihuka・Hinyoukika Clinic
Kumamoto, Kumamoto, 860-0066
Kyoto Furitsu Medical University Hospital
Kyoto, 602 8566
Hamaguchi Skin Clinic
Machida-shi, Tokyo, 194-0013
Charme Clinique
Matsudo, Chiba, 270-2223
Mita Dermatology Clinic
Minato-Ku, Tokyo, 108-0014
Queen's Square Dermatology and Allergology
Nishi-ku, Yokohama-city, Kanagawa, 220-6208
KAJI Dermatology Clinic
Nonoichi-shi, Ishikawa-ken, 921-8801
Takagi Dermatology
Obihiro, Hokkaido, 080-0013
Sanrui Dermatology Clinic
Ohmiya-ku,Saitama-shi, Saitama, 330-0854
Osaka City University Hospital
Osaka, 545-8586
Goto Dermatology Clinic
Osaka, 554-0021
Tanpopo Dermatology Clinic
Ōta-ku, Tokyo, 143-0023
Kume Clinic
Sakai, Osaka, 593-8324
Sapporo Skin Clinic
Sapporo, Hokkaido, 060-0063
Kobayashi Skin Clinic
Sapporo, Hokkaido, 060-0807
Dokkyo Medical University Hospital
Shimotsuga-Gun, Tochigi, 321 0293
Yamate Dermatological Clinic
Shinjuku, Tokyo, 169-0075
Yoshihara Dermatology Clinic
Sumida-ku, Tokyo, 130-0014
Tachikawa Dermatology Clinic
Tachikawa-shi, Tokyo, 190-0023
Shirasaki Clinic
Takaoka-shi, Toyama, 9330871
Yoshikawa Dermatology Clinic
Takatsuki, Osaka, 569-0824
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825

Other trials in Japan

About this study

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

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.

Conditions: Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Skin Diseases, Genetic
Being tested: Lebrikizumab, Placebo, Topical Corticosteroid
Keywords: Corticosteroids
Medical subject headings: Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Skin Diseases, Genetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LebrikizumabDrug
Also called LY3650150
Administered SC
PlaceboDrug
Administered SC
Topical CorticosteroidDrug
Self-applied

Study groups in NCT04760314
Study group	Role	What they receive
Lebrikizumab 250 mg Every 4 weeks (Q4W)	Experimental	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. Receives: Drug: Lebrikizumab; Drug: Topical Corticosteroid
Lebrikizumab 250 mg Every 2 weeks (Q2W)	Experimental	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. Receives: Drug: Lebrikizumab; Drug: Topical Corticosteroid
Placebo	Placebo comparator	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. Receives: Drug: Placebo; Drug: Topical Corticosteroid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to Week 16
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.
Measured: Week 16

Secondary outcomes (6)

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.
Measured: Baseline to Week 16
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.
Measured: Week 16
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."
Measured: Baseline to Week 1
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."
Measured: Baseline to Week 2
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."
Measured: Baseline to Week 4
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."
Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 20211 Feb 2023

First posted18 Feb 2021
Study start10 Mar 2021
Primary completion31 Jul 2022
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 286 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04760314
Sponsor's protocol ID: 17953
Other IDs: J2T-JE-KGAL
Acronym: ADhere-J
Status last verified: Jul 2023
First submitted: 10 Feb 2021
Last updated: 23 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Katoh N, Tanaka A, Takahashi H, Shimizu R, Kataoka Y, Torisu-Itakura H, Morisaki Y, Yamamoto C, Igawa K. Long-term management of moderate-to-severe atopic dermatitis with lebrikizumab and concomitant topical corticosteroids: a 68-week randomized double-blind placebo-controlled phase III trial in Japan (ADhere-J). Br J Dermatol. 2025 Mar 18;192(4):597-610. doi: 10.1093/bjd/ljae394.
PubMed 39442013

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dermatitis, Atopic trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04760314
Acronym / sponsor ID: ADhere-J / 17953
Conditions: Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Skin Diseases, Genetic
Keywords: Corticosteroids
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 286 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 10 Mar 2021 (actual)
Primary completion: 31 Jul 2022 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 18 Feb 2021 (actual)
Results: Posted 23 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Lebrikizumab 250 mg Every 4 weeks (Q4W)	Experimental	Drug: Lebrikizumab, Drug: 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)	Experimental	Drug: Lebrikizumab, Drug: 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.
Placebo	Placebo comparator	Drug: Placebo, Drug: Topical 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.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

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:
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:
Body weight ≥40 kilogram (kg)

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LebrikizumabAlso: LY3650150Administered SC	Drug	Lebrikizumab 250 mg Every 2 weeks (Q2W), Lebrikizumab 250 mg Every 4 weeks (Q4W)
PlaceboAdministered SC	Drug	Placebo
Topical CorticosteroidSelf-applied	Drug	Lebrikizumab 250 mg Every 2 weeks (Q2W), Lebrikizumab 250 mg Every 4 weeks (Q4W), Placebo

Primary outcome

Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
Time frame: 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
Time frame: 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.

6 secondary outcomes

Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16
Time frame: Baseline to Week 16
Percentage of Participants Achieving EASI-90 at Week 16
Time frame: Week 16
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
Time frame: Baseline to Week 1
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2
Time frame: Baseline to Week 2
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4
Time frame: Baseline to Week 4
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16
Time frame: Baseline to Week 16

Results and safety

Results posted to the registry on 23 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Induction - Placebo	82	82
Induction - Lebrikizumab 250mg Q4W	81	80
Induction - Lebrikizumab 250mg Q2W	123	120
Maintenance Blinded Period - Placebo Responder/Placebo	0	0
Maintenance Blinded Period - Lebrikizumab Q4W Responder/Lebrikizumab Q4W	0	0
Maintenance Blinded Period - Lebrikizumab Q2W Responder/ Lebrikizumab Q4W	0	0
Maintenance Blinded Period - Lebrikizumab Q2W Responder/Lebrikizumab Q2W	0	0
Escape Arm Week 16 - Maintenance Open Label - Placebo Non Responder/Lebrikizumab 250 mg Q2W	0	0
Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q4W Nonresponder/Lebrikizumab 250mg Q2W	0	0
Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q2W Nonresponder/Lebrikizumab 250mg Q2W	0	0
Escape Arm Week 20 to 64 Maintenance Open Label Lebrikizumab 250 Q2W	0	0

Primary outcome: Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Time frame: Baseline to Week 16. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Induction - Placebo n = 82	Induction - Lebrikizumab 250 mg Q4W n = 81	Induction - Lebrikizumab 250 mg Q2W n = 123
Value	6.1 (0.9 to 11.3)	29.1 (19.2 to 39.1)	33.4 (25.0 to 41.8)

Induction - Placebo vs Induction - Lebrikizumab 250 mg Q4W: Risk Difference (RD): 22.6 (95% CI 11.6 to 33.6), p <0.001, Cochran-Mantel-Haenszel
Induction - Placebo vs Induction - Lebrikizumab 250 mg Q2W: Risk Difference (RD): 27.3 (95% CI 17.5 to 37.0), p <0.001, Cochran-Mantel-Haenszel

Population analysed: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.

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

Time frame: Week 16. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Induction - Placebo n = 82	Induction - Lebrikizumab 250 mg Q4W n = 81	Induction - Lebrikizumab 250 mg Q2W n = 123
Value	13.4 (6.0 to 20.8)	47.2 (36.3 to 58.1)	51.2 (42.3 to 60.1)

Induction - Placebo vs Induction - Lebrikizumab 250 mg Q4W: Risk Difference (RD): 33.2 (95% CI 20.6 to 45.8), p <0.001, Cochran-Mantel-Haenszel
Induction - Placebo vs Induction - Lebrikizumab 250 mg Q2W: Risk Difference (RD): 37.6 (95% CI 26.2 to 49.0), p <0.001, Cochran-Mantel-Haenszel

Population analysed: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up To Week 68.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Induction - Placebo	2 of 82 (2.4%)	52 of 82 (63.4%)	0 of 82
Induction - Lebrikizumab 250mg Q4W	0 of 81 (0%)	49 of 81 (60.5%)	0 of 81
Induction - Lebrikizumab 250mg Q2W	1 of 123 (0.8%)	93 of 123 (75.6%)	0 of 123
Maintenance Blinded Period - Lebrikizumab Q4W Responder/Lebrikizumab Q4W	1 of 38 (2.6%)	31 of 38 (81.6%)	0 of 38
Maintenance Blinded Period - Lebrikizumab Q2W Responder/ Lebrikizumab Q4W	0 of 33 (0%)	25 of 33 (75.8%)	0 of 33
Maintenance Blinded Period - Lebrikizumab Q2W Responder/Lebrikizumab Q2W	1 of 32 (3.1%)	29 of 32 (90.6%)	0 of 32
Maintenance Blinded Period - Placebo Responder/Placebo	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11
Escape Arm Week 16 - Maintenance Open Label - Placebo Non Responder/Lebrikizumab 250 mg Q2W	1 of 71 (1.4%)	63 of 71 (88.7%)	0 of 71
Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q4W Nonresponder/Lebrikizumab 250mg Q2W	2 of 42 (4.8%)	36 of 42 (85.7%)	0 of 42
Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q2W Nonresponder/Lebrikizumab 250mg Q2W	1 of 55 (1.8%)	49 of 55 (89.1%)	0 of 55
Escape Arm Week 20 to 64 Maintenance Open Label Lebrikizumab 250 Q2W	1 of 8 (12.5%)	6 of 8 (75%)	0 of 8

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39442013Katoh N, Tanaka A, Takahashi H, Shimizu R, Kataoka Y, Torisu-Itakura H, Morisaki Y, Yamamoto C, Igawa K. Long-term management of moderate-to-severe atopic dermatitis with lebrikizumab and concomitant topical corticosteroids: a 68-week randomized double-blind placebo-controlled phase III trial in Japan (ADhere-J). Br J Dermatol. 2025 Mar 18;192(4):597-610. doi: 10.1093/bjd/ljae394.
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis (ADhere-J)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lebrikizumab and Topical Corticosteroid in people with Dermatitis, Atopic and Dermatitis, run by Eli Lilly and Company at 37 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04760314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.