Clinical trial NCT05372419: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index 75 (≥75% Reduction From Baseline in EASI) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving EASI 75 at Week 24
timeFrame: Week 24
measure: 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
timeFrame: Baseline to Week 16
measure: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Percentage Change From Baseline in Total EASI Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in Total EASI Score From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Total EASI Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Total EASI Score From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving EASI-90 From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: 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
timeFrame: Baseline to Week 16
measure: Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Percentage Change in Pruritus NRS Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: 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
timeFrame: Baseline to Week 16
measure: 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
timeFrame: Baseline to Week 24
measure: Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline inPatient-Oriented Eczema Measure (POEM) From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in POEM From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in DLQI From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in cDLQI From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 24
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Inglewood
country: United States
facility: Axon Clinical Research
state: California
city: Laguna Niguel
country: United States
facility: Avance Clinical Trials Inc
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group, Inc.
state: California
city: Palmdale
country: United States
facility: Cura Clinical Research
state: California
city: Sacramento
country: United States
facility: University of California Davis (UC Davis) Comprehensive Cancer Center
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Sherman Oaks
country: United States
facility: Cura Clinical Research
state: California
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research, Inc
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group, LLC
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Orlando
country: United States
facility: PureSkin Dermatology
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Beverly
country: United States
facility: Allcutis Research, Inc.
state: Massachusetts
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute - Troy
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, P.C
state: Nebraska
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Wilmington
country: United States
facility: Wilmington Health Family Medicine
state: North Carolina
city: Charleston
country: United States
facility: Dermatology & Laser Center of Charleston
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: