Clinical trial NCT04178967: Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab 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: 2019-11-26
Enrollment: 445
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 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


Eligibility criteria: Inclusion Criteria:

* Male or female adults and adolescents (≥12 years and ≥40 kg)
* Chronic atopic dermatitis (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 atopic dermatitis involvement at the baseline visit
* History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable

Exclusion Criteria:

* Prior treatment with dupilumab or tralokinumab
* Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
* 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 the following prior to the baseline visit:

  * An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
  * Cell-depleting biologics, including to rituximab, within 6 months of baseline
  * Other biologics within 5 half-lives (if known) or 16 weeks of baseline, 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, e.g., co-morbid severe uncontrolled asthma
* Evidence of active acute or chronic hepatitis
* History of human immunodeficiency virus (HIV) infection or positive HIV serology
* 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

Primary outcomes:
measure: Percentage of Participants With an Investigator 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 in EASI Score) From Baseline to Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2
timeFrame: Baseline to Week 2
measure: Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Percentage of Participants With an 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 EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage 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 Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage Change in EASI Score From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Percent Body Surface Area (BSA) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving EASI-90 From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving ≥4-point Improvement in DLQI From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage 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 Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants With a Pruritus NRS Score 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 Score 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 Score 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 Score of ≥5 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 Score 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 Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Percentage Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
timeFrame: Baseline, Week 16
measure: Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)
timeFrame: Predose at Week 52
measure: Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)
timeFrame: Baseline to Week 52
measure: Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 16 Who Continue to Exhibit an IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants From Those With a Pruritus NRS of ≥4-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants From Those With a Pruritus NRS of ≥5-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52
timeFrame: Baseline to Week 52
measure: Percentage Change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) From Baseline at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index
timeFrame: Baseline, Week 16
measure: Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (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-Adolescents
timeFrame: Baseline, Week 16
measure: Change From Baseline in PROMIS Anxiety at Week 16 - Adults
timeFrame: Baseline, Week 16
measure: Change From Baseline in PROMIS Depression at Week 16- Adolescents
timeFrame: Baseline, Week 16
measure: Change From Baseline in PROMIS Depression at Week 16- Adults
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: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Fresno
country: United States
facility: Woodward Centre
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: University Clinical Trials, Inc.
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology & Laser Clinic
state: California
city: Fort Myers
country: United States
facility: Clinical Physiology Associates, Clinical Study Center
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: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc
state: Georgia
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Baton Rouge
country: United States
facility: Meridian Clinical Research
state: Louisiana
city: Beverly
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Fridley
country: United States
facility: Associated Skin Care Specialists
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology 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: Exton
country: United States
facility: Dermatology and Skin Surgery Center
state: Pennsylvania
city: Hazleton
country: United States
facility: DermDOX
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Peak Research LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Dermatology & Laser Center of Charleston
state: South Carolina
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: Fort Worth
country: United States
facility: Innovate Research, LLC
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Murray
country: United States
facility: University of Utah MidValley Dematology
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Plovdiv
country: Bulgaria
facility: DCC Sveti Georgi
city: Sofia
country: Bulgaria
facility: Diagnostic and Consultation Center 14
city: Sofia
country: Bulgaria
facility: Alexandrovska University Hospital
city: Sofia
country: Bulgaria
facility: Euro Derma clinic
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: Medical centre Alitera-Med EOOD
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Barrie
country: Canada
facility: Simcoderm Medical & Surgical Dermatology Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North York
country: Canada
facility: North York Research Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen GmbH
state: Baden-Württemberg
city: Langenau
country: Germany
facility: Studienzentrum Dr.Beate Schwarz
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Hautarztpraxis am Löwenmarkt
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: licca Fachklinik
state: Bayern
city: Darmstadt
country: Germany
facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
state: Hessen
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: Niedersachsen
city: Osnabrück
country: Germany
facility: Klinische Forschung Osnabrück
state: Niedersachsen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Hautzentrum im Jahrhunderthaus
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universität Leipzig - Universitätsklinikum
state: Sachsen
city: Leipzig
country: Germany
facility: SIBAmed Studienzentrum GmbH & Co. KG
state: Saxony
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Augsburg
country: Germany
facility: Praxis Dr. Michael Dietlen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Campus Buch
city: Berlin
country: Germany
facility: ISA GmbH
city: Berlin
country: Germany
facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Morelia
country: Mexico
facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales
state: Michoacan Morelia
city: Aguascalientes
country: Mexico
facility: Derma Norte del Bajío, S.C.
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Kk Women'S and Childrens Hospital
city: Singapore
country: Singapore
facility: National Skin Centre NSC
city: Niaosong Dist
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
state: Kaohsiung City
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Institutional Review B
city: New Taipei City
country: Taiwan
facility: Taipei Medical University- Shuang Ho Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2
city: Rivne
country: Ukraine
facility: Rivne Regional Dermatology and Venereology Dispensary
city: Uzhhorod
country: Ukraine
facility: Treatment-diagnostic center PE "Asclepius"
city: Zaporizhzhya
country: Ukraine
facility: Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council
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: