A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Eli Lilly and Company86 enrolled

Overview

The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.

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: * All participants must have prior treatment with dupilumab meeting one of the following conditions: * Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months. * Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment. * Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment. * 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. 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 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 Dupilumab treatment within 4 weeks prior to baseline * Had prior treatment with tralokinumab. * Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline * Treatment with any of the following agents within 4 weeks prior to the baseline * systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants) * small molecules (e.g. JAK inhibitors) * phototherapy and photochemotherapy for AD

Locations (37)

Outcomes

Primary Outcomes

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) 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). The EASI-75 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

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.

Time frame: Baseline to Week 16

Data from ClinicalTrials.gov

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River Region Dermatology and Laser

Montgomery, Alabama, United States

Medical Dermatology Specialists

Phoenix, Arizona, United States

First OC Dermatology

Fountain Valley, 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

Clinical Science Institute

Santa Monica, California, United States

Cura Clinical Research

Sherman Oaks, California, United States

UConn Health

Farmington, Connecticut, United States

...and 27 more locations

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 EASI Total Score From Baseline to Week 16

Time frame: Baseline, Week 16

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

Time frame: Baseline, Week 24

Change in EASI Score From Baseline to Week 16

Time frame: Baseline, Week 16

Change in EASI Score From Baseline to Week 24

Time frame: Baseline, Week 24

Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) 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). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.

Time frame: 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). 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 at Least 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 at Least 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 of ≥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 of ≥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."

Time frame: Baseline to Week 24

Percentage Change From Baseline 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

Time frame: Baseline, Week 24

Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 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 of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24

Time frame: Baseline to Week 24

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

Time frame: Baseline, Week 16

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

Time frame: Baseline, Week 24

Change From Baseline in Skin Pain NRS 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, Week 16

Change From Baseline in Skin Pain NRS 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, 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

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, 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 Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7\*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease.

Time frame: Baseline, Week 16

Percentage Change From Baseline in SCORAD From Baseline to Week 24

SCORAD is a validated tool for assessing the extent and intensity of AD. It consists of three components: A) the extent of AD as a percentage of each body area, with a maximum score of 100%; B) the severity of six specific symptoms (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) rated from 0 (none) to 3 (severe) for a maximum of 18 points; and C) the subjective assessment of itch and sleeplessness on a visual analog scale (VAS) from 0 (no itch/sleeplessness) to 10 (worst imaginable itch/sleeplessness) with a maximum score of 20. The total SCORAD score is calculated as A/5 + 7\*B/2 + C, ranging from 0 (no disease) to 103 (severe disease).

Time frame: Baseline, Week 24