Clinical trial NCT04250337: Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Dermira, Inc.
First posted: 2020-01-31
Enrollment: 228
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, parallel group, placebo controlled
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

1. Male or female adult and adolescents (≥12 years to \<18 years, and weighing ≥40 kg).
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.

Exclusion Criteria:

1. Participation in a prior lebrikizumab clinical study.
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.

Primary outcomes:
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16
timeFrame: Baseline to Week 16
measure: Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percent Change in EASI Score From Baseline at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline to Week 16 in Percent Body Surface Area (BSA)
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving EASI-90 at Week 4
timeFrame: Baseline to Week 4
measure: Percent Change in Sleep-loss Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Sleep-loss Score at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
timeFrame: Baseline to Week 2
measure: Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
timeFrame: Baseline to Week 2
measure: Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points
timeFrame: Baseline to Week 16
measure: Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index
timeFrame: Baseline, Week 16
measure: Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults
timeFrame: Baseline, Week 16
measure: Change From Baseline in PROMIS Depression at Week 16 - Adults
timeFrame: Baseline, Week 16
measure: Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics
timeFrame: Baseline, Week 16
measure: Change From Baseline in PROMIS Depression at Week 16 - Pediatrics
timeFrame: Baseline, Week 16
measure: Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma
timeFrame: Baseline, Week 16
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Beverly Hills
country: United States
facility: Wallace Medical Group, Inc.
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group + Research Center
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine University of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center, INC
state: California
city: San Diego
country: United States
facility: ACRC Studies
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Washington
country: United States
facility: Foxhall Dermatology
state: District of Columbia
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Gainesville
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Medical Center
state: Florida
city: Hialeah
country: United States
facility: The Community Research of South Florida
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Vitae Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corp.
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists
state: Maryland
city: Beverly
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Fivenson Dermatology
state: Michigan
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Portsmouth
country: United States
facility: ALLCUTIS Research
state: New Hampshire
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Medford
country: United States
facility: Clinical Research Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Portland
country: United States
facility: OHSU Center for Health and Healing
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: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Montreal
country: Canada
facility: International Dermatology Research
state: Quebec
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hessen
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
state: Lower Saxony
city: Dresden
country: Germany
facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
state: Saxony
city: Berlin
country: Germany
facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Wroclaw
country: Poland
facility: DermMEDICA Sp. z o.o.
state: Dolnoslaskie
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
state: Malopolska
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
state: Podkarpackie
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy sp. z o.o.
state: Pomorskie
city: Ossy
country: Poland
facility: Labderm s.c.
state: Slaskie
city: Kielce
country: Poland
facility: Gabinet Dermatlogiczny. Beata Krecisz
state: Swietokrzyskie
city: Gdansk
country: Poland
facility: Clinica Vitae Sp. z o.o.
state: Woj. Pomorskie
city: Warszawa
country: Poland
facility: Clinical Research Group Sp. z o.o.
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA
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: