Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
ADore
An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
4 other identifiers
interventional
206
4 countries
70
Brief Summary
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2020
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
January 31, 2020
CompletedStudy Start
First participant enrolled
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2022
CompletedResults Posted
Study results publicly available
February 24, 2023
CompletedFebruary 24, 2023
January 1, 2023
2.2 years
January 30, 2020
December 15, 2022
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)
The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Week 52
Secondary Outcomes (11)
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline
Week 52
Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)
Week 52
Percentage Change From Baseline in EASI Score
Baseline, Week 52
Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score)
Week 52
Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score)
Week 52
- +6 more secondary outcomes
Study Arms (1)
Lebrikizumab 250 mg
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female adolescent (≥12 years to \<18 years, and weighing ≥40 kg).
- Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
- Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
- ≥10% body surface area (BSA) of AD involvement at the baseline visit.
- History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
You may not qualify if:
- Participation in a prior lebrikizumab clinical study.
- Treatment with the following prior to the baseline visit:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- Dupilumab within 8 weeks.
- B-cell-depleting biologics, including to rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- Uncontrolled chronic disease that might require bursts of oral corticosteroids.
- Evidence of active acute or chronic hepatitis
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- 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.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Dermira, Inc.collaborator
Study Sites (70)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
MD Studies
Fountain Valley, California, 92708, United States
Integrative Skin Science and Research
Sacramento, California, 95825, United States
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego, California, 92123, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
IMMUNOe International Research Centers
Centennial, Colorado, 80112, United States
C&R Research Services USA
Coral Gables, Florida, 33134, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134, United States
Pediatric Skin Research, LLC
Coral Gables, Florida, 33146, United States
Encore Medical Research
Hollywood, Florida, 33021, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256, United States
Well Pharma Medical Research Corp.
Miami, Florida, 33143, United States
Sanchez Clinical Research Inc
Miami, Florida, 33157, United States
Miami Dermatology and Laser Research
Miami, Florida, 33173, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Georgia Pollens Clinical Research Centers, Inc
Albany, Georgia, 31707, United States
Advanced Medical Research
Sandy Springs, Georgia, 30328, United States
Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419, United States
Northwestern University
Chicago, Illinois, 60611, United States
Sneeze, Wheeze, & Itch Associates LLC
Normal, Illinois, 61761, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Kansas Medical Clinic
Topeka, Kansas, 66614, United States
Skin Sciences, PLLC
Louisville, Kentucky, 40217, United States
Tulane Univ School of Med
New Orleans, Louisiana, 70112, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, 20850, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
St Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, 49085, United States
Central Dermatology PC
St Louis, Missouri, 63117, United States
ALLCUTIS Research
Portsmouth, New Hampshire, 03801, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11415, United States
Advanced Asthma and Allergy
Watertown, New York, 13601, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, 19103, United States
Arlington Research Center, Inc
Arlington, Texas, 76011, United States
Encore Imaging & Medical Research
Houston, Texas, 77065, United States
Cutis Wellness Dermatology
Laredo, Texas, 78041, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Acclaim Dermatology, PLLC
Sugar Land, Texas, 77497, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
The Skin Hospital
Sydney, New South Wales, 02010, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Royal Childrens Hospital Melbourne
Parkville, Victoria, 3052, Australia
Burswood Dermatology
Victoria Park, Western Australia, 06100, Australia
Captain Stirling Medical Centre
Nedlands, 6009, Australia
Institute for Skin Advancement
Calgary, Alberta, T3A 2N1, Canada
CARe Clinic
Red Deer, Alberta, T4N 6V7, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X3, Canada
The Centre for Clinical Trials, Inc
Oakville, Ontario, L6J7W5, Canada
AvantDerm
Toronto, Ontario, M5A3R6, Canada
Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
Krakow, Lesser Poland Voivodeship, 30-033, Poland
Diamond Clinic
Krakow, Lesser Poland Voivodeship, 31-559, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625, Poland
Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440, Poland
Provita Sp. z o.o
Katowice, 40-611, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin, 20-081, Poland
CityClinic Przychodnia Lekarsko-Psychologiczna
Wroclaw, 50-566, Poland
Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Lodz, Łódź Voivodeship, 90-436, Poland
Gabinet Dermatlogiczny. Beata Krecisz
Kielce, Świętokrzyskie Voivodeship, 25-155, Poland
Related Publications (1)
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.
PMID: 37318750DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2020
First Posted
January 31, 2020
Study Start
February 11, 2020
Primary Completion
April 20, 2022
Study Completion
June 22, 2022
Last Updated
February 24, 2023
Results First Posted
February 24, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.