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

NCT05369403 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 18499J2T-MC-KGBO
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 37

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.

Conditions

Atopic Dermatitis

Keywords

Eczema

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) 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). The EASI-75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.

  Week 16

Secondary Outcomes (27)

• 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 EASI Total Score From Baseline to Week 16

  Baseline, Week 16

• Percentage Change From Baseline in 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. 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 a 75% reduction in the EASI score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until 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:

• 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.

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 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (37)

River Region Dermatology and Laser

Montgomery, Alabama, 36117, United States

Location

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, 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

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

Total Vein and Skin LLC

Boynton Beach, Florida, 33437, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Hollywood Dermatology

Hollywood, Florida, 33021, United States

Location

Miami Dermatology and Laser Research

Miami, Florida, 33173, United States

Location

Ziaderm Research, LLC.

North Miami Beach, Florida, 33162, United States

Location

Olympian Clinical Research

Tampa, Florida, 33615, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Advanced Medical Research

Sandy Springs, Georgia, 30328, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, 20850, United States

Location

Allcutis Research, Inc.

Beverly, Massachusetts, 01915, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

The Derm Institute of West Michigan

Caledonia, Michigan, 49316, United States

Location

Revival Research Institute - Troy

Troy, Michigan, 48084, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Allcutis Research, Inc

Portsmouth, New Hampshire, 03801, United States

Location

Windsor Dermatology, P.C.

East Windsor, New Jersey, 08520, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

OptiSkin Medical

New York, New York, 10128, United States

Location

Dermatologists of Greater Columbus

Bexley, Ohio, 43209, United States

Location

Dermatology and Skin Surgery Center, PC

Exton, Pennsylvania, 19341, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Complete Dermatology

Sugar Land, Texas, 77479, United States

Location

Spokane Dermatology Clinic

Spokane, Washington, 99202, United States

Location

Related Publications (1)

• Silverberg JI, Ackerman L, Bagel J, Stein Gold L, Blauvelt A, Rosmarin D, Chovatiya R, Zirwas M, Yosipovitch G, Waibel J, Murase JE, Lockshin B, Weisman J, Atwater AR, Proper J, Silk M, Pierce E, Piruzeli MLB, Montmayeur S, Schuster C, Zhong J, Rueda MJ, Pillai S, Simpson E. Lebrikizumab Improves Clinical Manifestations, Symptoms, and Quality of Life in Patients with Moderate-to-Severe Atopic Dermatitis Previously Treated with Dupilumab: Results from the ADapt Study. Dermatol Ther (Heidelb). 2026 Feb;16(2):1309-1330. doi: 10.1007/s13555-025-01644-3. Epub 2026 Jan 19.

  PMID: 41553700 DERIVED

Related Links

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

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 6, 2022
• First Posted: May 11, 2022
• Study Start: December 19, 2022
• Primary Completion: January 11, 2024
• Study Completion: February 5, 2025
• Last Updated: February 25, 2026
• Results First Posted: March 19, 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: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (37)