Atopic DermatitisPhase 3ADmirableNCT05372419
A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color
A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis, run by Eli Lilly and Company at 36 sites in United States.
Trial summary
The main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (AD) and skin of color. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 36 sitesUnited States
- Study dates
- 12 Jan 2023to 17 Feb 2025
- Phase
- Phase 3
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
- Participants must be ≥12 years of age inclusive, at the time of signing the informed consent/assent.
- Participants who are self-reported race other than White, including but not limited to persons who self-identify as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander.
- Participants who are Fitzpatrick phototype IV-VI
- Participants who have chronic AD that has been present for ≥1 year before screening.
- Have EASI ≥16 at baseline
- Have IGA score ≥3 (Scale of 0 to 4) at baseline
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- Have ≥10% body surface area (BSA) of AD involvement at baseline
- Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
- Adolescents body weight must be ≥40 kg at baseline.
- Are willing and able to comply with all clinic visits and study-related procedures and questionnaires.
- Contraceptive use - Male and/or female
- Male participants are not required to use any contraception except in compliance with specific local government study requirements.
- Female participants of child-bearing potential: must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of study drug. Women of non-child-bearing potential (non-WOCBP) may participate without any contraception requirements.
Who cannot join
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- Have a current infection or chronic infection with hepatitis B virus (HBV) at screening, that is, positive for hepatitis B surface antigen (HBsAg) and/or polymerase chain reaction positive for HBV DNA
- Have a current infection with hepatitis C virus (HCV) at screening, that is, positive for HCV RNA
- Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator).
- Have uncontrolled asthma that
- might require bursts of oral or systemic corticosteroids, or
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- required the following due to ≥1 exacerbations within 12 months before baseline
- systemic (oral and/or parenteral) corticosteroid treatment, or
- hospitalization for >24 hours.
- Have known liver cirrhosis and/or chronic hepatitis of any etiology.
- Had prior treatment with dupilumab
- Had prior treatment with tralokinumab
- Treatment with topical agents (corticosteroids, calcineurin inhibitors, JAK inhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline.
- Treatment with any of the following agents within 4 weeks prior to the baseline:
- systemic immunosuppressive/immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants);
- small molecules (for example, Janus Kinase (JAK) inhibitors);
- phototherapy and photochemotherapy for AD.
- History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Arlington Research Center, Inc
Arlington, Texas, 76011
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
Allcutis Research, Inc.
Beverly, Massachusetts, 01915
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Encore Medical Research of Boynton Beach
Boynton Beach, Florida, 33436
Dermatology & Laser Center of Charleston
Charleston, South Carolina, 29407
UConn Health
Farmington, Connecticut, 06030-2840
First OC Dermatology
Fountain Valley, California, 92708
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
Skin Care Research, Inc
Hollywood, Florida, 33021
Clinical Trial Network
Houston, Texas, 77074
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Axon Clinical Research
Inglewood, California, 90301
Solutions Through Advanced Research
Jacksonville, Florida, 32256
Avance Clinical Trials Inc
Laguna Niguel, California, 92677
Dermatology Research Associates
Los Angeles, California, 90045
Wallace Medical Group, Inc.
Los Angeles, California, 90056
Skin Care Physicians of Georgia
Macon, Georgia, 31217
Miami Dermatology and Laser Research
Miami, Florida, 33173
Savin Medical Group, LLC
Miami Lakes, Florida, 33014
Sadick Research Group
New York, New York, 10075
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Skin Specialists, P.C
Omaha, Nebraska, 68144
PureSkin Dermatology
Orlando, Florida, 32819
Cura Clinical Research
Palmdale, California, 93551
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95816
Progressive Clinical Research
San Antonio, Texas, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Advanced Medical Research
Sandy Springs, Georgia, 30328
Clinical Science Institute
Santa Monica, California, 90404
Cura Clinical Research
Sherman Oaks, California, 91403
Washington University School of Medicine
St Louis, Missouri, 63110
Complete Dermatology
Sugar Land, Texas, 77479
Revival Research Institute - Troy
Troy, Michigan, 48084
Wilmington Health Family Medicine
Wilmington, North Carolina, 28411
About this study
Official title: An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color
The main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (AD) and skin of color.
- Conditions
- Atopic Dermatitis
- Being tested
- Lebrikizumab
- Keywords
- Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Also called LY3650150, DRM06
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab 250 mg Q2W | Experimental | Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Receives: Drug: Lebrikizumab |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W | Experimental | Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met. Receives: Drug: Lebrikizumab |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Experimental | Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met. Receives: Drug: Lebrikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Eczema Area and Severity Index 75 (≥75% Reduction From Baseline in EASI) at Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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) at each time point. The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.
Measured: Week 16
Secondary outcomes (29)
Percentage of Participants Achieving EASI 75 at Week 24
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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) at each time point. The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.
Measured: Week 24
Percentage of Participants With an Investigator's 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 AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point.
Measured: Baseline to Week 16
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point.
Measured: Baseline to Week 24
Percentage Change From Baseline in Total EASI Score From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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) at each time point.
Measured: Baseline, Week 16
Percentage Change From Baseline in Total EASI Score From Baseline to Week 24
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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) at each time point.
Measured: Baseline, Week 24
Change From Baseline in Total EASI Score From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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) at each time point.
Measured: Baseline, Week 16
Change From Baseline in Total EASI Score From Baseline to Week 24
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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) at each time point.
Measured: Baseline, Week 24
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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) at each time point. The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.
Measured: Baseline to Week 16
Percentage of Participants Achieving EASI-90 From Baseline to Week 24
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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) at each time point. The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.
Measured: Baseline to Week 24
Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 16
Pruritus NRS is 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
Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24
Pruritus NRS is 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 24
Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 16
Pruritus NRS is 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
Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 24
Pruritus NRS is 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. Assessments were recorded daily by the participant using an electronic diary.
Measured: Baseline to Week 24
Percentage Change in Pruritus NRS Score From Baseline to Week 16
Pruritus NRS is 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." Assessments were recorded daily by the participant using an electronic diary.
Measured: Baseline, Week 16
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24
Pruritus NRS is 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." Assessments were recorded daily by the participant using an electronic diary.
Measured: Baseline, Week 24
Percentage of Participants With a Sleep-Loss Scale Score of ≥2 Points at Baseline Who Achieve a 2-point Reduction From Baseline to Week 16
Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.
Measured: Baseline to Week 16
Percentage of Participants With a Sleep-Loss Scale Score of ≥2 Points at Baseline Who Achieve a 2-point Reduction From Baseline to Week 24
Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.
Measured: Baseline to Week 24
Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 16
Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.
Measured: Baseline, Week 16
Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 24
Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.
Measured: Baseline, Week 24
Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 16
The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable."
Measured: Baseline to Week 16
Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24
The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable."
Measured: Baseline to Week 24
Change From Baseline in Patient-Oriented Eczema Measure (POEM) From Baseline to Week 16
The POEM is a simple, participant-reported, 7-item scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the past week. Response categories include "No days," "1-2 days," "3-4 days," "5-6 days," and "Every day" with corresponding scores of 0, 1, 2, 3, and 4, respectively The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.
Measured: Baseline, Week 16
Change From Baseline in POEM From Baseline to Week 24
The POEM is a simple, participant-reported, 7-item scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the past week. Response categories include "No days," "1-2 days," "3-4 days," "5-6 days," and "Every day" with corresponding scores of 0, 1, 2, 3, and 4, respectively The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.
Measured: Baseline, Week 24
Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16
The DLQI questionnaire designed for participants aged >=16 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
Measured: Baseline, Week 16
Change From Baseline in DLQI From Baseline to Week 24
The DLQI questionnaire designed for participants aged >=16 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
Measured: Baseline, Week 24
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) From Baseline to Week 16
The CDLQI questionnaire designed for participants aged <16 years and It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).
Measured: Baseline, Week 16
Change From Baseline in cDLQI From Baseline to Week 24
The CDLQI questionnaire designed for participants aged <16 years and It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).
Measured: Baseline, Week 24
Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 16
The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment over the previous week. Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively. Questions 3-10 have an additional response category of "not relevant," which is scored as "0." Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life.
Measured: Baseline to Week 16
Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 24
The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment over the previous week. Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively. Questions 3-10 have an additional response category of "not relevant," which is scored as "0." Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start12 Jan 2023
- Primary completion3 May 2024
- Study completion17 Feb 2025
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 Atopic DermatitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372419
- Sponsor's protocol ID
- 18500
- Other IDs
- J2T-MC-KGBP
- Acronym
- ADmirable
- Status last verified
- Feb 2026
- First submitted
- 9 May 2022
- Last updated
- 9 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Alexis A, Moiin A, Waibel J, Wallace P, Cohen D, Laquer V, Kwong P, Atwater AR, Schuster C, Proper J, Silk M, Pierce E, Pillai S, Rueda MJ, Moore A; ADmirable Investigators. Efficacy and Safety of Lebrikizumab in Adult and Adolescent Patients with Skin of Color and Moderate-to-Severe Atopic Dermatitis: Results from the Phase IIIb, Open-Label ADmirable Study. Am J Clin Dermatol. 2025 Sep;26(5):803-817. doi: 10.1007/s40257-025-00970-8. Epub 2025 Jul 15.
PubMed 40665146