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

Eli Lilly and Company90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

LebrikizumabDRUG

Administered SC

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (36)

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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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

Palmdale, California, United States

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, United States

Clinical Science Institute

Santa Monica, California, United States

...and 26 more locations

Time frame: 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

Time frame: Baseline to Week 24

Percentage Change From Baseline in Total EASI Score From Baseline to Week 16

Time frame: Baseline, Week 16

Percentage Change From Baseline in Total EASI Score From Baseline to Week 24

Time frame: Baseline, Week 24

Change From Baseline in Total EASI Score From Baseline to Week 16

Time frame: Baseline, Week 16

Change From Baseline in Total EASI Score From Baseline to Week 24

Time frame: 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.

Time frame: 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.

Time frame: 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."

Time frame: 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."

Time frame: 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."

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Baseline to Week 24

Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 16

Time frame: Baseline, Week 16

Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 24

Time frame: 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."

Time frame: 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."

Time frame: 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.

Time frame: Baseline, Week 16

Change From Baseline in POEM From Baseline to Week 24

Time frame: 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.

Time frame: Baseline, Week 16

Change From Baseline in DLQI From Baseline to Week 24

Time frame: 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).

Time frame: Baseline, Week 16

Change From Baseline in cDLQI From Baseline to Week 24

Time frame: 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.

Time frame: 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

Time frame: Baseline to Week 24