Clinical trial NCT05369403: A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Official title: An Open-Label, Study to Evaluate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 86
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) 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 EASI Total Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in EASI Score From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in EASI Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in 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 at Least 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 at Least 4-point Reduction From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants With a Pruritus NRS of ≥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 of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Percentage Change From Baseline 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 of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: 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
timeFrame: Baseline to Week 24
measure: Change From Baseline in Sleep-Loss Scale From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Sleep-Loss Scale From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Skin Pain NRS From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Skin Pain NRS 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 Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in SCORAD From Baseline to Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: River Region Dermatology and Laser
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Fountain Valley
country: United States
facility: First OC Dermatology
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: 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: Boynton Beach
country: United States
facility: Total Vein and Skin LLC
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hollywood
country: United States
facility: Hollywood Dermatology
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: North Miami Beach
country: United States
facility: Ziaderm Research, LLC.
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
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: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Lake Charles
country: United States
facility: Dermatology and Advanced Aesthetics
state: Louisiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC
state: Maryland
city: Beverly
country: United States
facility: Allcutis Research, Inc.
state: Massachusetts
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Caledonia
country: United States
facility: The Derm Institute of West Michigan
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute - Troy
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Portsmouth
country: United States
facility: Allcutis Research, Inc
state: New Hampshire
city: East Windsor
country: United States
facility: Windsor Dermatology, P.C.
state: New Jersey
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: New York
country: United States
facility: OptiSkin Medical
state: New York
city: Bexley
country: United States
facility: Dermatologists of Greater Columbus
state: Ohio
city: Exton
country: United States
facility: Dermatology and Skin Surgery Center, PC
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Sugar Land
country: United States
facility: Complete Dermatology
state: Texas
city: Spokane
country: United States
facility: Spokane Dermatology Clinic
state: Washington
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: