A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden

Purpose

The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy. Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening visit. - Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline. - Have pruritus numeric rating scale (NRS) ≥6 at baseline. - Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline. - Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) at screening and baseline. - Based on investigator judgement, have a history of inadequate response to treatment with topical medications, or determination that topical treatments are otherwise medically inadvisable. - For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) at baseline.

Exclusion Criteria

  • Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator). - Have known liver cirrhosis and/or chronic hepatitis of any etiology. - History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks. - Are diagnosed with active endoparasitic infections or at high risk of these infections. - Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per the investigator's judgment. - Have presence of skin comorbidities that may interfere with study assessments. - Have a severe concomitant illness(es) that in the investigator's judgment would adversely affect the participant's participation in the study. - Have had any of the following types of infection within 3 months of screening or develop any of these infections during screening: - Serious (requiring hospitalization, and/or intravenous or equivalent oral antibiotic treatment). - Opportunistic - Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over. - Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer). - Recurring (including, but not limited to, recurring cellulitis and chronic osteomyelitis). - Have an active or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit or superficial skin infections within 1 week before the baseline visit. - Have had any prior treatment with a biologic therapy for AD. - Have had treatment with any of the following agents within 4 weeks prior to the baseline visit: - systemic immunosuppressive or immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma, - azathioprine, methotrexate, and other immunosuppressants) - small molecules (for example, Janus kinase inhibitors [topical or systemic]), or - phototherapy and photochemotherapy for AD. - Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to baseline.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lebrikizumab 		Lebrikizumab administered subcutaneously (SC).
  • Drug: Lebrikizumab
    Administered SC
    Other names:
    • LY3650150

Recruiting Locations

Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham 4049979, Alabama 4829764 35203
Contact:
205-380-6148

Research Solutions of Arizona
Litchfield Park 5302053, Arizona 5551752 85340
Contact:
623-512-4340

Alliance Dermatology and Mohs Center
Phoenix 5308655, Arizona 5551752 85032
Contact:
602-971-0268

California Dermatology & Clinical Research Institute
Encinitas 5346646, California 5332921 92024
Contact:
760 203-3839 et 101

First OC Dermatology Research Inc
Fountain Valley 5350207, California 5332921 92708
Contact:
714-531-2966

Dermatology Research Associates
Los Angeles 5368361, California 5332921 90045
Contact:
310-337-7171

NorCal Clinical Research
Rocklin 5388319, California 5332921 95765
Contact:
916-524-1216

Suncoast Research Associates
Doral 4153471, Florida 4155751 33172
Contact:
786-623-3135

Encore Medical Research
Hollywood 4158928, Florida 4155751 33024
Contact:
954-400-1725

Solutions Through Advanced Research
Jacksonville 4160021, Florida 4155751 32256
Contact:
904-619-8157

Life Arc Research Centers - Miami
Miami 4164138, Florida 4155751 33126
Contact:
305-874-7401

MCR Research
Miami 4164138, Florida 4155751 33126
Contact:
305-456-4760

Health Clinical Research
Miami 4164138, Florida 4155751 33176
Contact:
786-280-1977

Deluxe Health Center
Miami Lakes 4164186, Florida 4155751 33014
Contact:
305-209-1268

Renstar Medical Research
Ocala 4166673, Florida 4155751 34470
Contact:
352-629-5800

Leading Edge Dermatology
Plantation 4168782, Florida 4155751 33317
Contact:
954-371-2208

Research Institute of the Southeast
West Palm Beach 4177887, Florida 4155751 33401
Contact:
561-655-9055

Dermatology Affiliates Research Institute
Atlanta 4180439, Georgia 4197000 30305
Contact:
404-806-5291

DeNova Research
Chicago 4887398, Illinois 4896861 60602

Southern Indiana Clinical Research Center
Columbus 4256038, Indiana 4921868 47201
Contact:
812-418-7493

Dawes Fretzin Clinical Research Group, LLC
Indianapolis 4259418, Indiana 4921868 46250
Contact:
317-516-5030

Southern Indiana Clinical Trials
New Albany 4262045, Indiana 4921868 47150
Contact:
502-373-8133

Equity Medical - Bowling Green
Bowling Green 4285268, Kentucky 6254925 42104
Contact:
270-213-7777

Allergy & Asthma Specialists, P.S.C.
Owensboro 4303436, Kentucky 6254925 42301
Contact:
270-684-6144

Foxhall Research Center
Chevy Chase 4351335, Maryland 4361885 20815

Great Lakes Research Group, Inc.
Bay City 4985180, Michigan 5001836 48706
Contact:
989-895-9100

Revival Research Institute, LLC
Troy 5012639, Michigan 5001836 48084
Contact:
248-590-0298

Albuquerque Clinical Trials, Inc.
Albuquerque 5454711, New Mexico 5481136 87102
Contact:
505-224-7407

Equity Medical
New York 5128581, New York 5128638 10023

Hickory Dermatology Research Center
Hickory 4470778, North Carolina 4482348 28602

Wright State Physicians
Fairborn 4511263, Ohio 5165418 45324
Contact:
937-245-7500

ObjectiveHealth - Goodlettsville Dermatology Research
Goodlettsville 4625282, Tennessee 4662168 37072

John Peter Smith Hospital
Fort Worth 4691930, Texas 4736286 76104

Reveal Research Institute - Frisco
Frisco 4692559, Texas 4736286 75033
Contact:
469-225-9920

Biopharma Informatic, LLC
Houston 4699066, Texas 4736286 77084
Contact:
281-944-3610

Prime Clinical Research - Mansfield
Mansfield 4709013, Texas 4736286 76063
Contact:
817-907-7330

Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio 4726206, Texas 4736286 78235
Contact:
210-852-2779

Jordan Valley Dermatology & Research Center
South Jordan 5781770, Utah 5549030 84095

Dr. Samuel Sanchez PSC
Caguas 4563008, Puerto Rico 00725
Contact:
787-746-3136

Caribbean Medical Research Center
San Juan 4568127, Puerto Rico 00918

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com