Clinical trial NCT03443024: A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Dermira, Inc.
First posted: 2018-02-22
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16
timeFrame: Week 16
measure: 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)
timeFrame: Week 16
measure: Percentage of Participants With EASI <7 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving EASI50 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving EASI90 at Week 16
timeFrame: Week 16
measure: Percent Change From Baseline in the Sleep Loss Scale Score
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16
timeFrame: Week 16
measure: Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center
state: Arizona
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center-Medical Dermatology Clinic
state: California
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Washington
country: United States
facility: George Washington Medical Faculty Associates
state: District of Columbia
city: Boynton Beach
country: United States
facility: Total Vein and Skin
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD PA
state: Florida
city: Sanford
country: United States
facility: International Clinical Research - US, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Integrated Clinical Research, LLC
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research, Inc.
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC
state: Georgia
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC
state: Maryland
city: Beverly
country: United States
facility: ActivMed Practices & Research, Inc.
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Las Vegas
country: United States
facility: JDR Dermatology Research
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Schweiger Dermatology, PLLC
state: New York
city: New York
country: United States
facility: Icahn School of Medicine
state: New York
city: New York
country: United States
facility: Sadick Research Group, LLC.
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc.
state: New York
city: Charlotte
country: United States
facility: Piedmont Plastic Surgery and Dermatology
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center
state: Tennessee
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Austin
country: United States
facility: Westlake Dermatology Clinical Research Center
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research
state: Texas
city: Houston
country: United States
facility: The University of Texas Health
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: Guttman-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.