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:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 57 Locations for this study

See Locations Near You

Total Skin and Beauty Dermatology Center, PC
Birmingham Alabama, 35205, United States More Info
Contact
205-380-6148
James Krell
Principal Investigator
River Region Dermatology and Laser
Montgomery Alabama, 36117, United States More Info
Contact
407-442-0243
Porcia Love
Principal Investigator
Medical Dermatology Specialists
Phoenix Arizona, 85006, United States More Info
Contact
602-354-4248
Lindsay Ackerman
Principal Investigator
First OC Dermatology
Fountain Valley California, 92708, United States More Info
Vivian Laquer
Principal Investigator
Center For Dermatology Clinical Research, Inc.
Fremont California, 94538, United States More Info
Contact
510-797-4111
Sunil Dhawan
Principal Investigator
Axon Clinical Research
Inglewood California, 90301, United States More Info
Contact
909-447-9317
Marcia J Glenn
Principal Investigator
Avance Trials
Laguna Niguel California, 92677, United States More Info
Contact
818-859-2792
Tanya Evans
Principal Investigator
Dermatology Research Associates
Los Angeles California, 90045, United States More Info
Howard Sofen
Principal Investigator
Wallace Medical Group, Inc.
Los Angeles California, 90056, United States More Info
Contact
213-699-9444
Paul Wallace
Principal Investigator
UCSF Medical Center at Mission Bay
San Francisco California, 94115, United States More Info
Contact
415-353-9684
Tina Bhutani
Principal Investigator
Clinical Science Institute
Santa Monica California, 90404, United States More Info
Contact
3108288887
Paul Steven Yamauchi
Principal Investigator
Cura Clinical Research
Sherman Oaks California, 91403, United States More Info
Contact
833-525-2872
Michael Lin
Principal Investigator
UConn Health
Farmington Connecticut, 06030, United States More Info
Jun Lu
Principal Investigator
Skin Care Research, Inc
Boca Raton Florida, 33486, United States More Info
Contact
561-948-3116
Ann Reed
Principal Investigator
Encore Medical Research of Boynton Beach
Boynton Beach Florida, 33436, United States More Info
Contact
5614984407
Brian Jeffrey Feinstein
Principal Investigator
Total Vein and Skin, LLC
Boynton Beach Florida, 33437, United States More Info
Contact
561-739-5255
Joshua Berlin
Principal Investigator
Access Research Institute
Brooksville Florida, 34613, United States More Info
Contact
352-691-1140
Oliver M. Reed
Principal Investigator
Doral Medical Research
Doral Florida, 33166, United States More Info
Ashleigh Siegel
Principal Investigator
Direct Helpers Medical Center
Hialeah Florida, 33012, United States More Info
Contact
305-828-3555
Frank Don
Principal Investigator
Skin Care Research, Inc
Hollywood Florida, 33021, United States More Info
Contact
561-750-9873
Eduardo T Weiss
Principal Investigator
Altus Research
Lake Worth Florida, 33461, United States More Info
Contact
567-704-2933
Thomas Ross
Principal Investigator
Olympian Clinical Research
Largo Florida, 33770, United States More Info
Matthew Zook
Principal Investigator
Savin Medical Group, LLC
Miami Lakes Florida, 33014, United States More Info
Contact
608-848-8900
David A Rodriguez
Principal Investigator
Century Research LLC
Miami Florida, 33173, United States More Info
Contact
786-351-7572
Danielle Nicolazzo
Principal Investigator
Miami Dermatology and Laser Research
Miami Florida, 33173, United States More Info
Contact
305-279-6060
Jill S Waibel
Principal Investigator
Tory Sullivan, MD PA
North Miami Beach Florida, 33162, United States More Info
Contact
305-652-8600
Tory Sullivan
Principal Investigator
Research Institute of the southeast
West Palm Beach Florida, 33401, United States More Info
Contact
561-655-9055
Kenneth Beer
Principal Investigator
Skin Care Physicians of Georgia
Macon Georgia, 31217, United States More Info
Contact
478-742-2180
David Cohen
Principal Investigator
Marietta Dermatology Clinical Research
Marietta Georgia, 30060, United States More Info
Contact
770-422-1013
Mark Knautz
Principal Investigator
Advanced Medical Research
Sandy Springs Georgia, 30328, United States More Info
Jamie Debra Weisman
Principal Investigator
NorthShore University HealthSystem
Skokie Illinois, 60077, United States More Info
Contact
847-663-8536
Joel Joyce
Principal Investigator
Dundee Dermatology
West Dundee Illinois, 60118, United States More Info
Contact
847-851-8889
Paul Getz
Principal Investigator
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46250, United States More Info
Contact
3175165030
Scott Alfred Fretzin
Principal Investigator
Skin Sciences, PLLC
Louisville Kentucky, 40217, United States More Info
Contact
502-4519-000
Leon H Kircik
Principal Investigator
Dermatology Specialists Research
Louisville Kentucky, 40241, United States More Info
Contact
502-585-9059
Cindy Owen
Principal Investigator
Dr. Shondra Smith MD
Lake Charles Louisiana, 70605, United States More Info
Contact
337-477-0011
Shondra L Smith
Principal Investigator
Best Clinical Trials
New Orleans Louisiana, 70115, United States More Info
Contact
504-897-5211
William C Claiborne
Principal Investigator
Dermatology and Skin Cancer Specialists, LLC
Rockville Maryland, 20850, United States More Info
Contact
301-355-3183
Benjamin Lockshin
Principal Investigator
ActivMed Practices and Research
Beverly Massachusetts, 01915, United States More Info
Contact
978-927-5254
David S Greenstein
Principal Investigator
Oakland Hills Dermatology
Auburn Hills Michigan, 48326, United States More Info
Contact
248-756-3500
Christofer Buatti
Principal Investigator
Great Lakes Research Group, Inc.
Bay City Michigan, 48706, United States More Info
Brent Boyce
Principal Investigator
The Derm Institute of West Michigan
Caledonia Michigan, 49316, United States More Info
Contact
616-3260-114
Kristi Hawley
Principal Investigator
Revival Research Institute - Troy
Troy Michigan, 48084, United States More Info
Ali Moiin
Principal Investigator
MediSearch Clinical Trials
Saint Joseph Missouri, 64506, United States More Info
Contact
816-364-1515
Melody Stone
Principal Investigator
Skin Specialists, P.C
Omaha Nebraska, 68144, United States More Info
Joel Schlessinger
Principal Investigator
ActivMed Practices and Research
Portsmouth New Hampshire, 03801, United States More Info
Contact
603-319-8863
Abel Jarell
Principal Investigator
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States More Info
Contact
609-443-4500
Jerry Bagel
Principal Investigator
Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
Hackensack New Jersey, 07601, United States More Info
Contact
201-951-0701
David J Goldberg
Principal Investigator
Rochester Skin Lymphoma Medical Group, PLLC
Fairport New York, 14450, United States More Info
Contact
585-364-1188
Brian Poligone
Principal Investigator
Sadick Research Group
New York New York, 10075, United States More Info
Contact
212-517-9566
Neil S Sadick
Principal Investigator
Markowitz Medical
New York New York, 10128, United States More Info
Contact
212-828-3120
Orit Markowitz
Principal Investigator
Dermatologists of Greater Columbus
Bexley Ohio, 43209, United States More Info
Matthew James Zirwas
Principal Investigator
The Pennsylvania Centre for Dermatology, LLC
Exton Pennsylvania, 19341, United States More Info
Contact
610-7237-159
Scott Gottlieb
Principal Investigator
Clinical Partners, LLC
Johnston Rhode Island, 02919, United States More Info
Contact
4014543800
Kathleen Pieroni Gordon
Principal Investigator
Arlington Research Center, Inc
Arlington Texas, 76011, United States More Info
Angela Y Moore
Principal Investigator
Complete Dermatology
Sugar Land Texas, 77479, United States More Info
Contact
281-757-6351
Bartley J Gill
Principal Investigator
Premier Clinical Research
Spokane Washington, 99202, United States More Info
William P. Werschler
Principal Investigator
West Virginia Research Institute
Morgantown West Virginia, 26505, United States More Info
Contact
304-598-3888
Rola Gharib
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT05369403

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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