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 (ADmirable)

April 15, 2024 updated by: Eli Lilly and Company

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Total Skin and Beauty Dermatology Center, PC
        • Contact:
          • Phone Number: 205-380-6148
        • Principal Investigator:
          • James M Krell
      • Montgomery, Alabama, United States, 36117
        • Recruiting
        • River Region Dermatology and Laser
        • Principal Investigator:
          • Porcia Love
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • First OC Dermatology
        • Contact:
          • Phone Number: 714-531-2966
        • Principal Investigator:
          • Vivian Laquer
      • Fremont, California, United States, 94538
        • Recruiting
        • Center for Dermatology Clinical Research, Inc.
        • Contact:
          • Phone Number: 510-797-4111
        • Principal Investigator:
          • Sunil Dhawan
      • Inglewood, California, United States, 90301
        • Recruiting
        • Axon Clinical Research
        • Contact:
          • Phone Number: 424-309-9057
        • Principal Investigator:
          • Marcia Glenn
      • Laguna Niguel, California, United States, 92677
        • Recruiting
        • Avance Clinical Trials Inc
        • Principal Investigator:
          • Tanya Evans
        • Contact:
          • Phone Number: 949-844-0442
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates
        • Contact:
          • Phone Number: 310-337-7171
        • Principal Investigator:
          • Howard Sofen
      • Los Angeles, California, United States, 90056
        • Recruiting
        • Wallace Medical Group, Inc.
        • Principal Investigator:
          • Paul Wallace
      • Palmdale, California, United States, 93551
        • Recruiting
        • Cura Clinical Research
        • Principal Investigator:
          • Aram Kechichian
        • Contact:
          • Phone Number: 833-525-2872
      • Sacramento, California, United States, 95816
        • Recruiting
        • University of California Davis (UC Davis) Comprehensive Cancer Center
        • Contact:
          • Phone Number: 916-551-2633
        • Principal Investigator:
          • Emanual Maverakis
      • San Francisco, California, United States, 94127
        • Recruiting
        • San Francisco Research Institute
        • Contact:
          • Phone Number: 415-549-9362
        • Principal Investigator:
          • David Wong
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Clinical Science Institute
        • Contact:
          • Phone Number: 310-828-8887
        • Principal Investigator:
          • Paul Yamauchi
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Cura Clinical Research
        • Principal Investigator:
          • Michael Lin
        • Contact:
          • Phone Number: 310-550-6756
    • Connecticut
      • Farmington, Connecticut, United States, 06030-2840
        • Recruiting
        • UConn Health
        • Principal Investigator:
          • Jun Lu
        • Contact:
          • Phone Number: 8606793475
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Skin Care Research, Inc
        • Contact:
          • Phone Number: 561-948-3116
        • Principal Investigator:
          • Ann Reed
      • Boynton Beach, Florida, United States, 33436
        • Recruiting
        • Encore Medical Research of Boynton Beach
        • Principal Investigator:
          • Brian Jeffrey Feinstein
        • Contact:
          • Phone Number: 561-774-8799
      • Boynton Beach, Florida, United States, 33437
        • Recruiting
        • Total Vein and Skin Llc
        • Contact:
          • Phone Number: 561-739-5252
        • Principal Investigator:
          • Joshua Berlin
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Accel Research Sites
        • Principal Investigator:
          • Neil Sandhu
        • Contact:
          • Phone Number: 904-740-0770
      • Doral, Florida, United States, 33122
        • Recruiting
        • D&H Doral Research Center LLC
        • Contact:
          • Phone Number: 786-698-8508
        • Principal Investigator:
          • Brent Schillinger
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Skin Care Research, Inc
        • Contact:
          • Phone Number: 954-674-3535
        • Principal Investigator:
          • Eduardo Weiss
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Solutions Through Advanced Research
        • Principal Investigator:
          • Pearl Kwong
        • Contact:
          • Phone Number: 904-519-5292
      • Miami, Florida, United States, 33173
        • Recruiting
        • Miami Dermatology and Laser Research
        • Contact:
          • Phone Number: 305-279-6060
        • Principal Investigator:
          • Jill S Waibel
      • Miami, Florida, United States, 33137
        • Recruiting
        • Skin and Cancer Associates, LLP
        • Contact:
          • Phone Number: 305-531-5788
        • Principal Investigator:
          • Heather Woolery-Lloyd
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Savin Medical Group, LLC
        • Principal Investigator:
          • David Rodriguez
        • Contact:
          • Phone Number: 305-558-7559
      • Orlando, Florida, United States, 32819
        • Recruiting
        • PureSkin Dermatology
        • Principal Investigator:
          • Debra Grayman
    • Georgia
      • Macon, Georgia, United States, 31217
        • Recruiting
        • Skin Care Physicians of Georgia
        • Contact:
          • Phone Number: 478-742-2180
        • Principal Investigator:
          • David Cohen
      • Sandy Springs, Georgia, United States, 30328
        • Recruiting
        • Advanced Medical Research
        • Principal Investigator:
          • Jamie Weisman
        • Contact:
          • Phone Number: 404-355-1919
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Dawes Fretzin Clinical Research Group, LLC
        • Contact:
          • Phone Number: 317-516-5030
        • Principal Investigator:
          • Kenneth Dawes
    • Maryland
      • Columbia, Maryland, United States, 21104
        • Not yet recruiting
        • Kindred Hair and Skin
        • Principal Investigator:
          • Chesanha Kindred
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Recruiting
        • Allcutis Research, Inc.
        • Contact:
          • Phone Number: 978-969-6897
        • Principal Investigator:
          • David Greenstein
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • Recruiting
        • Oakland Hills Dermatology
        • Contact:
          • Phone Number: 248-858-2255
        • Principal Investigator:
          • Christofer Buatti
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute - Troy
        • Principal Investigator:
          • Ali Moiin
        • Contact:
          • Phone Number: 248-564-1485
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Milan Anadkat
        • Contact:
          • Phone Number: 314-362-8171
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists, P.C
        • Principal Investigator:
          • Joel Schlessinger
        • Contact:
          • Phone Number: 402-697-6597
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • Allcutis Research
        • Contact:
          • Phone Number: 603-319-8863
        • Principal Investigator:
          • Abel Jarell
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Sadick Research Group
        • Contact:
          • Phone Number: 212-772-7242
        • Principal Investigator:
          • Neil Sadick
      • New York, New York, United States, 10075
        • Not yet recruiting
        • Weil Cornell Medicine Dermatology Research
        • Contact:
          • Phone Number: 646-962-2090
        • Principal Investigator:
          • Alexis Andrew
    • North Carolina
      • Wilmington, North Carolina, United States, 28411
        • Recruiting
        • Wilmington Health Family Medicine
        • Contact:
          • Phone Number: 910-815-6108
        • Principal Investigator:
          • James Appel
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Not yet recruiting
        • Temple University Hospital
        • Principal Investigator:
          • Candrice Heath
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • Dermatology & Laser Center of Charleston
        • Principal Investigator:
          • Todd Schlesinger
        • Contact:
          • Phone Number: 854-333-5455
    • Texas
      • Arlington, Texas, United States, 76011
        • Recruiting
        • Arlington Research Center, Inc
        • Contact:
          • Phone Number: 817-795-7546
        • Principal Investigator:
          • Angela Moore
      • Houston, Texas, United States, 77074
        • Recruiting
        • Clinical Trial Network
        • Contact:
          • Phone Number: 713-484-6947
        • Principal Investigator:
          • Mushtaq Khan
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Dermatology Clinical Research Center of San Antonio
        • Principal Investigator:
          • Steven Davis
        • Contact:
          • Phone Number: 210-614-3355
      • San Antonio, Texas, United States, 78218
        • Recruiting
        • Texas Dermatology and Laser Specialists
        • Contact:
          • Phone Number: 210-852-2779
        • Principal Investigator:
          • John Browning
      • San Antonio, Texas, United States, 78213
        • Recruiting
        • Progressive Clinical Research
        • Principal Investigator:
          • Mark Stewart Lee
        • Contact:
          • Phone Number: 12106145557
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Complete Dermatology
        • Contact:
          • Phone Number: 281-240-4313
        • Principal Investigator:
          • Bartley Gill
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Clinical Research, Inc.
        • Contact:
          • Phone Number: 757-625-0151
        • Principal Investigator:
          • David M. Pariser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lebrikizumab
Participants will receive Lebrikizumab subcutaneously (SC).
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 from baseline in EASI)
Time Frame: Baseline to Week 16
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a ≥75% Reduction from Baseline in EASI-75
Time Frame: Baseline to Week 24
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
Time Frame: Baseline to Week 16
Baseline to Week 16
Percentage of Participants with an IGA score of 0 or 1 and a Reduction ≥2 Points from Baseline
Time Frame: Baseline to Week 24
Baseline to Week 24
Percentage Change from Baseline in total EASI
Time Frame: Baseline, Week 16
Baseline, Week 16
Percentage Change from Baseline in total EASI
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in total EASI
Time Frame: Baseline, Week 16
Baseline, Week 16
Change from Baseline in total EASI
Time Frame: Baseline, Week 24
Baseline, Week 24
Percentage of Participants Achieving a ≥90% Reduction from Baseline in EASI-90
Time Frame: Baseline to Week 16
Baseline to Week 16
Percentage of Participants Achieving a ≥90% Reduction from Baseline in EASI-90
Time Frame: Baseline to Week 24
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
Time Frame: Baseline to Week 16
Baseline to Week 16
Percentage of Participants with a Pruritus NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline
Time Frame: Baseline to Week 24
Baseline to Week 24
Percentage of Participants with a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline
Time Frame: Baseline to Week 16
Baseline to Week 16
Percentage of Participants with a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline
Time Frame: Baseline to Week 24
Baseline to Week 24
Percentage Change from Baseline in Pruritus NRS Score
Time Frame: Baseline, Week 16
Baseline, Week 16
Percentage Change from Baseline in Pruritus NRS Score
Time Frame: Baseline, Week 24
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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 24
Baseline to Week 24
Percentage Change from Baseline in Sleep-Loss Scale Score
Time Frame: Baseline, Week 16
Baseline, Week 16
Percentage Change from Baseline in Sleep-Loss Scale Score
Time Frame: Baseline, Week 24
Baseline, Week 24
Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 24
Baseline to Week 24
Change from Baseline in Patient-Oriented Eczema Measure (POEM)
Time Frame: Baseline, Week 16
Baseline, Week 16
Change from Baseline in POEM
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Dermatology Life Quality Index (DLQI)
Time Frame: Baseline, Week 16
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
Time Frame: Baseline, Week 24
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)
Time Frame: Baseline, Week 16
Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.
Baseline, Week 16
Change from Baseline in cDLQI
Time Frame: Baseline, Week 24
Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study
Baseline, Week 24
Percentage of Participants with a DLQI of ≥4 points at Baseline Who Achieve a ≥4-point Improvement in DLQI
Time Frame: Baseline to Week 16
Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
Baseline to Week 16
Percentage of Participants with a DLQI of ≥4 points at Baseline Who Achieve a ≥4-point Improvement in DLQI
Time Frame: Baseline to Week 24
Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 12, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18500
  • J2T-MC-KGBP (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

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 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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