Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT04250350
Last Updated: 2023-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2020-02-11
2022-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lebrikizumab 250 mg
Participants received two subcutaneous (SC) injections of 250 milligram(mg) Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Lebrikizumab
Subcutaneous injection
Interventions
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Lebrikizumab
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.
6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
Exclusion Criteria
2. Treatment with the following prior to the baseline visit:
1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
2. Dupilumab within 8 weeks.
3. B-cell-depleting biologics, including to rituximab, within 6 months.
4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.
5. Evidence of active acute or chronic hepatitis
6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
12 Years
17 Years
ALL
No
Sponsors
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Dermira, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Arkansas Research Trials, LLC
North Little Rock, Arkansas, United States
Hope Clinical Research
Canoga Park, California, United States
First OC Dermatology
Fountain Valley, California, United States
MD Studies
Fountain Valley, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
C&R Research Services USA
Coral Gables, Florida, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, United States
Pediatric Skin Research, LLC
Coral Gables, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
Well Pharma Medical Research Corp.
Miami, Florida, United States
Sanchez Clinical Research Inc
Miami, Florida, United States
Miami Dermatology and Laser Research
Miami, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Georgia Pollens Clinical Research Centers, Inc
Albany, Georgia, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Georgia Skin & Cancer Clinic
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates LLC
Normal, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Kansas Medical Clinic
Topeka, Kansas, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
Tulane Univ School of Med
New Orleans, Louisiana, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
St Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, United States
Central Dermatology PC
St Louis, Missouri, United States
ALLCUTIS Research
Portsmouth, New Hampshire, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Advanced Asthma and Allergy
Watertown, New York, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Central States Research
Tulsa, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, United States
Arlington Research Center, Inc
Arlington, Texas, United States
Encore Imaging & Medical Research
Houston, Texas, United States
Cutis Wellness Dermatology
Laredo, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Acclaim Dermatology, PLLC
Sugar Land, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
PI-Coor Clinical Research, LLC
Burke, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Woden Dermatology
Phillip, Australian Capital Territory, Australia
The Skin Hospital
Sydney, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Royal Childrens Hospital Melbourne
Parkville, Victoria, Australia
Burswood Dermatology
Victoria Park, Western Australia, Australia
Captain Stirling Medical Centre
Nedlands, , Australia
Institute for Skin Advancement
Calgary, Alberta, Canada
CARe Clinic
Red Deer, Alberta, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
The Centre for Clinical Trials, Inc
Oakville, Ontario, Canada
AvantDerm
Toronto, Ontario, Canada
Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
Krakow, Lesser Poland Voivodeship, Poland
Diamond Clinic
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland
Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
Iwonicz-Zdrój, Podkarpackie Voivodeship, Poland
Provita Sp. z o.o
Katowice, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin, , Poland
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw, , Poland
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz, Łódź Voivodeship, Poland
Gabinet Dermatlogiczny. Beata Krecisz
Kielce, Świętokrzyskie Voivodeship, Poland
Countries
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References
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Paller AS, Flohr C, Eichenfield LF, Irvine AD, Weisman J, Soung J, Pinto Correia A, Natalie CR, Rodriguez Capriles C, Pierce E, Reifeis S, Gontijo Lima R, Armengol Tubau C, Laquer V, Weidinger S. Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study. Dermatol Ther (Heidelb). 2023 Jul;13(7):1517-1534. doi: 10.1007/s13555-023-00942-y. Epub 2023 Jun 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (ADore)
Other Identifiers
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J2T-DM-KGAE
Identifier Type: OTHER
Identifier Source: secondary_id
DRM06-AD17
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004301-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17804
Identifier Type: -
Identifier Source: org_study_id
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