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

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Lebrikizumab

Registration Number: NCT05372419

Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

Inclusion Criteria

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
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.

Exclusion Criteria

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
- 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lebrikizumab 250 mg Q2W	Lebrikizumab	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Eczema Area and Severity Index 75 (≥75% Reduction From Baseline in EASI) at Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24	Baseline, 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. Results for Week 24 data will be presented at the time of reporting the final results.
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	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.
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	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. Results for Week 24 data will be presented at the time of reporting the final results.
Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 16	Baseline, 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.
Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 24	Baseline, 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. Results for Week 24 data will be presented at the time of reporting the final results.
Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 16	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."
Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24	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." Results for Week 24 data will be presented at the time of reporting the final results.
Change From Baseline inPatient-Oriented Eczema Measure (POEM) From Baseline to Week 16	Baseline, 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.
Percentage of Participants Achieving EASI 75 at Week 24	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. Results for Week 24 data will be presented at the time of reporting the final results.
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	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.
Percentage Change From Baseline in Total EASI Score From Baseline to Week 16	Baseline, 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.
Percentage Change From Baseline in Total EASI Score From Baseline to Week 24	Baseline, 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. Results for Week 24 data will be presented at the time of reporting the final results.
Change From Baseline in Total EASI Score From Baseline to Week 16	Baseline, 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.
Change From Baseline in Total EASI Score From Baseline to Week 24	Baseline, 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. Results for Week 24 data will be presented at the time of reporting the final results.
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16	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.
Percentage of Participants Achieving EASI-90 From Baseline to Week 24	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. Results for Week 24 data will be presented at the time of reporting the final results.
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	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."
Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24	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." Results for Week 24 data will be presented at the time of reporting the final results.
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24	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. Results for Week 24 data will be presented at the time of reporting the final results.
Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 16	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."
Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 24	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. Results for Week 24 data will be presented at the time of final results reporting.
Percentage Change in Pruritus NRS Score From Baseline to Week 16	Baseline, 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.
Change From Baseline in POEM From Baseline to Week 24	Baseline, 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. Results for Week 24 data will be presented at the time of reporting the final results.
Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16	Baseline, 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.
Change From Baseline in DLQI From Baseline to Week 24	Baseline, 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. Results for Week 24 data will be presented at the time of reporting the final results.
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) From Baseline to Week 16	Baseline, 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).
Change From Baseline in cDLQI From Baseline to Week 24	Baseline, 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). Results for Week 24 data will be presented at the time of reporting the final results.
Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 16	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.
Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 24	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. Results for Week 24 data will be presented at the time of reporting the final results.

Trial Locations

Locations (35): Total Skin and Beauty Dermatology Center, PC
🇺🇸
Birmingham, Alabama, United States
First OC Dermatology
🇺🇸
Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc.
🇺🇸
Fremont, California, United States
Axon Clinical Research
🇺🇸
Inglewood, California, United States
Avance Clinical Trials Inc
🇺🇸
Laguna Niguel, California, United States
Dermatology Research Associates
🇺🇸
Los Angeles, California, United States
Wallace Medical Group, Inc.
🇺🇸
Los Angeles, California, United States
Cura Clinical Research
🇺🇸
Sherman Oaks, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
🇺🇸
Sacramento, California, United States
Clinical Science Institute
🇺🇸
Santa Monica, California, United States
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Total Skin and Beauty Dermatology Center, PC
🇺🇸Birmingham, Alabama, United States