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NCT05369403 | Active, not recruiting | Atopic Dermatitis


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

Eli Lilly and Company

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.

Condition or disease

Atopic Dermatitis

Intervention/treatment

Lebrikizumab

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 120 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2022
Estimated Primary Completion Date : January 11, 2024
Estimated Study Completion Date : December 2024
Arm Intervention/treatment

Experimental: Lebrikizumab

Participants will receive Lebrikizumab by subcutaneous (SC) injection.

Drug: Lebrikizumab

Ages Eligible for Study: 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Alabama

River Region Dermatology and Laser

Montgomery, Alabama, United States, 36117

Not yet recruiting

United States, Arizona

Medical Dermatology Specialists

Phoenix, Arizona, United States, 85006

Not yet recruiting

United States, California

First OC Dermatology

Fountain Valley, California, United States, 92708

Not yet recruiting

United States, California

Axon Clinical Research

Inglewood, California, United States, 90301

Not yet recruiting

United States, California

Avance Clinical Trials Inc

Laguna Niguel, California, United States, 92677

Not yet recruiting

United States, California

Dermatology Research Associates

Los Angeles, California, United States, 90045

Not yet recruiting

United States, California

Wallace Medical Group, Inc.

Los Angeles, California, United States, 90056

Not yet recruiting

United States, California

Clinical Science Institute

Santa Monica, California, United States, 90404

Not yet recruiting

United States, California

Cura Clinical Research

Sherman Oaks, California, United States, 91403

Not yet recruiting

United States, Connecticut

UConn Health

Farmington, Connecticut, United States, 06030

Not yet recruiting

United States, Florida

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, United States, 33436

Not yet recruiting

United States, Florida

Total Vein and Skin LLC

Boynton Beach, Florida, United States, 33437

Not yet recruiting

United States, Florida

Direct Helpers Research Center

Hialeah, Florida, United States, 33012

Not yet recruiting

United States, Florida

Skin Care Research, Inc

Hollywood, Florida, United States, 33021

Not yet recruiting

United States, Florida

Miami Dermatology and Laser Research

Miami, Florida, United States, 33173

Not yet recruiting

United States, Florida

Ziaderm Research, LLC.

North Miami Beach, Florida, United States, 33162

Not yet recruiting

United States, Florida

Olympian Clinical Research

Tampa, Florida, United States, 33614

Not yet recruiting

United States, Georgia

Skin Care Physicians of Georgia

Macon, Georgia, United States, 31217

Not yet recruiting

United States, Georgia

Advanced Medical Research

Sandy Springs, Georgia, United States, 30328

Not yet recruiting

United States, Illinois

Dundee Dermatology

West Dundee, Illinois, United States, 60118

Not yet recruiting

United States, Indiana

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

Not yet recruiting

United States, Louisiana

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, United States, 70605

Not yet recruiting

United States, Maryland

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States, 20850

Not yet recruiting

United States, Massachusetts

Allcutis Research, Inc.

Beverly, Massachusetts, United States, 01915

Not yet recruiting

United States, Michigan

Oakland Hills Dermatology

Auburn Hills, Michigan, United States, 48326

Not yet recruiting

United States, Michigan

The Derm Institute of West Michigan

Caledonia, Michigan, United States, 49316

Not yet recruiting

United States, Michigan

Revival Research Institute - Troy

Troy, Michigan, United States, 48084

Not yet recruiting

United States, Missouri

MediSearch Clinical Trials

Saint Joseph, Missouri, United States, 64506

Not yet recruiting

United States, New Hampshire

Allcutis Research, Inc

Portsmouth, New Hampshire, United States, 03801

Not yet recruiting

United States, New Jersey

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States, 08520

Not yet recruiting

United States, New York

Sadick Research Group

New York, New York, United States, 10075

Not yet recruiting

United States, New York

OptiSkin Medical

New York, New York, United States, 10128

Not yet recruiting

United States, Ohio

Dermatologists of Southwest Ohio

Bexley, Ohio, United States, 43209

Not yet recruiting

United States, Rhode Island

Clinical Partners, LLC

Johnston, Rhode Island, United States, 02919

Not yet recruiting

United States, Texas

Complete Dermatology

Sugar Land, Texas, United States, 77479

Not yet recruiting

United States, Washington

Premier Clinical Research

Spokane, Washington, United States, 99202

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