Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT05369403

Recruitment Status:

Active, not recruiting

Sponsor:

Eli Lilly and Company

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There are 36 Locations for this study

See Locations Near You

River Region Dermatology and Laser
Montgomery Alabama, 36117, United States
Medical Dermatology Specialists
Phoenix Arizona, 85006, United States
First OC Dermatology
Fountain Valley California, 92708, United States
Axon Clinical Research
Inglewood California, 90301, United States
Avance Clinical Trials Inc
Laguna Niguel California, 92677, United States
Dermatology Research Associates
Los Angeles California, 90045, United States
Wallace Medical Group, Inc.
Los Angeles California, 90056, United States
Clinical Science Institute
Santa Monica California, 90404, United States
Cura Clinical Research
Sherman Oaks California, 91403, United States
UConn Health
Farmington Connecticut, 06030, United States
Encore Medical Research of Boynton Beach
Boynton Beach Florida, 33436, United States
Total Vein and Skin LLC
Boynton Beach Florida, 33437, United States
Direct Helpers Research Center
Hialeah Florida, 33012, United States
Skin Care Research, Inc
Hollywood Florida, 33021, United States
Miami Dermatology and Laser Research
Miami Florida, 33173, United States
Ziaderm Research, LLC.
North Miami Beach Florida, 33162, United States
Olympian Clinical Research
Tampa Florida, 33614, United States
Skin Care Physicians of Georgia
Macon Georgia, 31217, United States
Advanced Medical Research
Sandy Springs Georgia, 30328, United States
Dundee Dermatology
West Dundee Illinois, 60118, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46250, United States
Dermatology and Advanced Aesthetics
Lake Charles Louisiana, 70605, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville Maryland, 20850, United States
Allcutis Research, Inc.
Beverly Massachusetts, 01915, United States
Oakland Hills Dermatology
Auburn Hills Michigan, 48326, United States
The Derm Institute of West Michigan
Caledonia Michigan, 49316, United States
Revival Research Institute - Troy
Troy Michigan, 48084, United States
MediSearch Clinical Trials
Saint Joseph Missouri, 64506, United States
Allcutis Research, Inc
Portsmouth New Hampshire, 03801, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Sadick Research Group
New York New York, 10075, United States
OptiSkin Medical
New York New York, 10128, United States
Dermatologists of Southwest Ohio
Bexley Ohio, 43209, United States
Clinical Partners, LLC
Johnston Rhode Island, 02919, United States
Complete Dermatology
Sugar Land Texas, 77479, United States
Premier Clinical Research
Spokane Washington, 99202, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT05369403

Recruitment Status:

Active, not recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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