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

NCT05372419 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 18500J2T-MC-KGBP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 36

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.

Conditions

Atopic Dermatitis

Keywords

Eczema

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Eczema Area and Severity Index 75 (≥75% Reduction From Baseline in EASI) 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) at each time point. The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.

  Week 16

Secondary Outcomes (29)

• Percentage of Participants Achieving EASI 75 at Week 24

  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

  Baseline to Week 16

• Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24

  Baseline to Week 24

• Percentage Change From Baseline in Total EASI Score From Baseline to Week 16

  Baseline, Week 16

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

  Baseline, Week 24

Study Arms (3)

Lebrikizumab 250 mg Q2W

EXPERIMENTAL

Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.

Drug: Lebrikizumab

Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W

EXPERIMENTAL

Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.

Drug: Lebrikizumab

Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W

EXPERIMENTAL

Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.

Drug: Lebrikizumab

Interventions

Lebrikizumab DRUG

Administered SC

Also known as: LY3650150, DRM06

Lebrikizumab 250 mg Q2W; Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W; Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (36)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Axon Clinical Research

Inglewood, California, 90301, United States

Location

Avance Clinical Trials Inc

Laguna Niguel, California, 92677, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Wallace Medical Group, Inc.

Los Angeles, California, 90056, United States

Location

Cura Clinical Research

Palmdale, California, 93551, United States

Location

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, 95816, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Cura Clinical Research

Sherman Oaks, California, 91403, United States

Location

UConn Health

Farmington, Connecticut, 06030-2840, United States

Location

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, 33436, United States

Location

Skin Care Research, Inc

Hollywood, Florida, 33021, United States

Location

Solutions Through Advanced Research

Jacksonville, Florida, 32256, United States

Location

Miami Dermatology and Laser Research

Miami, Florida, 33173, United States

Location

Savin Medical Group, LLC

Miami Lakes, Florida, 33014, United States

Location

PureSkin Dermatology

Orlando, Florida, 32819, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Advanced Medical Research

Sandy Springs, Georgia, 30328, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Allcutis Research, Inc.

Beverly, Massachusetts, 01915, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Revival Research Institute - Troy

Troy, Michigan, 48084, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Skin Specialists, P.C

Omaha, Nebraska, 68144, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Wilmington Health Family Medicine

Wilmington, North Carolina, 28411, United States

Location

Dermatology & Laser Center of Charleston

Charleston, South Carolina, 29407, United States

Location

Arlington Research Center, Inc

Arlington, Texas, 76011, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Complete Dermatology

Sugar Land, Texas, 77479, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

• Alexis A, Moiin A, Waibel J, Wallace P, Cohen D, Laquer V, Kwong P, Atwater AR, Schuster C, Proper J, Silk M, Pierce E, Pillai S, Rueda MJ, Moore A; ADmirable Investigators. Efficacy and Safety of Lebrikizumab in Adult and Adolescent Patients with Skin of Color and Moderate-to-Severe Atopic Dermatitis: Results from the Phase IIIb, Open-Label ADmirable Study. Am J Clin Dermatol. 2025 Sep;26(5):803-817. doi: 10.1007/s40257-025-00970-8. Epub 2025 Jul 15.

  PMID: 40665146 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800- 545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: January 12, 2023
• Primary Completion: May 3, 2024
• Study Completion: February 17, 2025
• Last Updated: March 9, 2026
• Results First Posted: June 11, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

US (36)