A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
3 other identifiers
interventional
280
1 country
58
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2018
Shorter than P25 for phase_2
58 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
Study Start
First participant enrolled
January 30, 2018
CompletedFirst Submitted
Initial submission to the registry
February 16, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2019
CompletedResults Posted
Study results publicly available
May 4, 2021
CompletedMay 4, 2021
July 1, 2020
1 year
February 16, 2018
April 9, 2021
April 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Eczema Area and Severity Index (EASI)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using analysis of covariance (ANCOVA) with the factor of treatment and the baseline EASI as covariate. Note: Missing values were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation.
Baseline, Week 16
Secondary Outcomes (11)
Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16
Week 16
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale)
Week 16
Percentage of Participants With EASI <7 at Week 16
Week 16
Percentage of Participants Achieving EASI50 at Week 16
Week 16
Percentage of Participants Achieving EASI90 at Week 16
Week 16
- +6 more secondary outcomes
Study Arms (4)
125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)
EXPERIMENTAL125 mg Lebrikizumab administered subcutaneously (SC) once Q4W. Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-milliliter (mL) of 125 mg/mL Lebrikizumab and 1-mL placebo). Week 2: Four 1-mL SC injections placebo. Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo. Weeks 6, 10, 14: Two 1-mL SC placebo.
250 mg Lebrikizumab - Q4W
EXPERIMENTAL250 mg Lebrikizumab administered SC once Q4W. Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 2: Four 1-mL SC injections of placebo. Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab). Weeks 6, 10, 14: Two 1-mL injections of placebo.
250 mg Lebrikizumab - Every 2 Weeks (Q2W)
EXPERIMENTAL250 mg Lebrikizumab administered SC once Q2W. Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab).
Group 4 - Placebo
PLACEBO COMPARATORPlacebo administered SC once Q2W. Baseline and Week 2: Four 1-mL SC injections of placebo. Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.
Interventions
Sterile liquid solution administered subcutaneously.
Solution administered subcutaneously.
Eligibility Criteria
You may qualify if:
- Male or female, 18 years or older.
- Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
- Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
- ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.
You may not qualify if:
- Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD.
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.
- Treatment with:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
- Dupilumab within 3 months prior to baseline visit.
- Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
- Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).
- Use of prescription moisturizers within 7 days of the baseline visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Dermira, Inc.collaborator
Study Sites (58)
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255, United States
Dermatology Trial Associates
Bryant, Arkansas, 72022, United States
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
University of Southern California
Los Angeles, California, 90033, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Stanford Medicine Outpatient Center-Medical Dermatology Clinic
Redwood City, California, 94063, United States
Center for Dermatology and Laser Surgery
Sacramento, California, 95819, United States
UCSD Dermatology
San Diego, California, 92122, United States
TCR Medical Corporation
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Total Vein and Skin
Boynton Beach, Florida, 33437, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134, United States
Olympian Clinical Research
Largo, Florida, 33770, United States
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162, United States
International Clinical Research - US, LLC
Sanford, Florida, 32771, United States
Integrated Clinical Research, LLC
West Palm Beach, Florida, 33406, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060, United States
Advanced Medical Research, PC
Sandy Springs, Georgia, 30328, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Kansas City Dermatology, PA
Overland Park, Kansas, 66215, United States
Skin Sciences, PLLC
Louisville, Kentucky, 40217, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70808, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, 20850, United States
ActivMed Practices & Research, Inc.
Beverly, Massachusetts, 01915, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Somerset Skin Centre
Troy, Michigan, 48084, United States
JDR Dermatology Research
Las Vegas, Nevada, 89148, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, 03801, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Schweiger Dermatology, PLLC
New York, New York, 10022, United States
Icahn School of Medicine
New York, New York, 10029, United States
Sadick Research Group, LLC.
New York, New York, 10075, United States
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790, United States
Piedmont Plastic Surgery and Dermatology
Charlotte, North Carolina, 28277, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Wilmington Dermatology Center
Wilmington, North Carolina, 28405, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
Rivergate Dermatology Clinical Research Center
Goodlettsville, Tennessee, 37072, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
Westlake Dermatology Clinical Research Center
Austin, Texas, 78746, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
Menter Dermatology Research
Dallas, Texas, 75246, United States
The University of Texas Health
Houston, Texas, 77030, United States
Progressive Clinical Research, PA
San Antonio, Texas, 78213, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, 77598, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Dermatology Associates of Seattle
Seattle, Washington, 98101, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Related Publications (2)
Rams A, Baldasaro J, Bunod L, Delbecque L, Strzok S, Meunier J, ElMaraghy H, Sun L, Pierce E. Assessing Itch Severity: Content Validity and Psychometric Properties of a Patient-Reported Pruritus Numeric Rating Scale in Atopic Dermatitis. Adv Ther. 2024 Apr;41(4):1512-1525. doi: 10.1007/s12325-024-02802-3. Epub 2024 Feb 16.
PMID: 38363461DERIVEDGuttman-Yassky E, Blauvelt A, Eichenfield LF, Paller AS, Armstrong AW, Drew J, Gopalan R, Simpson EL. Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis: A Phase 2b Randomized Clinical Trial. JAMA Dermatol. 2020 Apr 1;156(4):411-420. doi: 10.1001/jamadermatol.2020.0079.
PMID: 32101256DERIVED
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 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2018
First Posted
February 22, 2018
Study Start
January 30, 2018
Primary Completion
February 7, 2019
Study Completion
May 23, 2019
Last Updated
May 4, 2021
Results First Posted
May 4, 2021
Record last verified: 2020-07
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 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.