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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Lebrikizumab

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • River Region Dermatology and Laser
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists
      • Principal Investigator: Lindsay Ackerman
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Inglewood, California, United States, 90301
      • Axon Clinical Research
    • Laguna Niguel, California, United States, 92677
      • Avance Clinical Trials Inc
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90056
      • Wallace Medical Group, Inc.
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
      • Contact: Phone Number: 3108288887
    • Sherman Oaks, California, United States, 91403
      • Cura Clinical Research
  • Connecticut
    • Farmington, Connecticut, United States, 06030-2840
      • UConn Health
  • Florida
    • Boynton Beach, Florida, United States, 33436
      • Encore Medical Research of Boynton Beach
    • Boynton Beach, Florida, United States, 33437
      • Total Vein and Skin Llc
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Hollywood, Florida, United States, 33021
      • Hollywood Dermatology
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Research
    • North Miami Beach, Florida, United States, 33162
      • Ziaderm Research, LLC.
    • Tampa, Florida, United States, 33615
      • Olympian Clinical Research
  • Georgia
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research
  • Illinois
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Dermatology and Advanced Aesthetics
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Dermatology and Skin Cancer Specialists, LLC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Allcutis Research, Inc.
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology
    • Caledonia, Michigan, United States, 49316
      • The Derm Institute of West Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute - Troy
      • Principal Investigator: Ali Moiin
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Allcutis Research, Inc
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Windsor Dermatology, P.C.
  • New York
    • New York, New York, United States, 10075
      • Sadick Research Group
    • New York, New York, United States, 10128
      • OptiSkin Medical
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Dermatologists of Greater Columbus
      • Principal Investigator: Matthew James Zirwas
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Dermatology and Skin Surgery Center, PC
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • Texas
    • Sugar Land, Texas, United States, 77479
      • Complete Dermatology
  • Washington
    • Spokane, Washington, United States, 99202
      • Spokane Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab; Participants will receive Lebrikizumab by subcutaneous (SC) injection.	Drug: Lebrikizumab; Administered SC; Other Names: LY3650150; DRM06

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >75% Reduction in EASI Score	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change from Baseline in Pruritus NRS Score		Baseline, Week 16
Percentage Change from Baseline in Pruritus NRS Score		Baseline, Week 24
Change from Baseline in Dermatology Life Quality Index (DLQI)	Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.	Baseline, Week 16
Change from Baseline in DLQI	Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.	Baseline, Week 24
Change from Baseline in Children's Dermatology Life Quality Index (cDLQI)	Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.	Baseline, Week 16
Percentage of Participants Achieving EASI-75		Baseline to Week 24
Percentage of Participants with an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points from Baseline		Baseline to Week 16
Percentage of Participants with an IGA Score of 0 or 1 and a Reduction ≥2 Points from Baseline		Baseline to Week 24
Percentage Change from Baseline in EASI		Baseline, Week 16
Percentage Change from Baseline in EASI		Baseline, Week 24
Change from Baseline in EASI		Baseline, Week 16
Change from Baseline in EASI		Baseline, Week 24
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline		Baseline to Week 16
Percentage of Participants Achieving EASI-90 from Baseline		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		Baseline to Week 16
Percentage of Participants with a Pruritus NRS of ≥4 points at Baseline Who Achieve at least 4-point Reduction		Baseline to Week 24
Percentage of Participants with a Pruritus NRS of ≥3 points at Baseline Who Achieve at least 3-point Reduction		Baseline to Week 16
Percentage of Participants with a Pruritus NRS of ≥3 points at Baseline Who Achieve at least 3-point Reduction		Baseline to Week 24
Percentage of Participants with a Sleep-Loss Scale of ≥2 points at Baseline Who Achieve at least 2-point Reduction		Baseline to Week 16
Percentage of Participants with a Sleep-Loss Scale of ≥2 points at Baseline Who Achieve at least 2-point Reduction		Baseline to Week 24
Change from Baseline in Sleep-Loss Scale		Baseline, Week 16
Change from Baseline in Sleep-Loss Scale		Baseline, Week 24
Change from Baseline in Skin Pain NRS		Baseline, Week 16
Change from Baseline in Skin Pain NRS		Baseline, Week 24
Change from Baseline in cDLQI	Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.	Baseline, Week 24
Percentage Change from Baseline in SCORing Atopic Dermatitis (SCORAD)		Baseline, Week 16
Percentage Change from Baseline in SCORAD		Baseline, Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Actual): January 11, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Eczema
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 18499; J2T-MC-KGBO (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No