Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT03533751
Last Updated: 2023-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
302 participants
INTERVENTIONAL
2018-06-19
2019-12-03
Brief Summary
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This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects with Moderate to Severe Atopic Dermatitis (AD).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.
Placebo
Administered by subcutaneous injection
Etokimab 20 mg SC Q4W
Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.
Etokimab
Humanized monoclonal antibody, administered by subcutaneous injection
Etokimab 300 mg load + 150 mg SC Q8W
Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.
Etokimab
Humanized monoclonal antibody, administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Etokimab 300 mg load + 150 mg SC Q4W
Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.
Etokimab
Humanized monoclonal antibody, administered by subcutaneous injection
Etokimab 600 mg load + 300 mg SC Q4W
Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Etokimab
Humanized monoclonal antibody, administered by subcutaneous injection
Interventions
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Etokimab
Humanized monoclonal antibody, administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m\^2) at screening.
3. Clinically confirmed diagnosis of AD.
4. Eczema Area and Severity Index (EASI) score ≥ 16, body surface area (BSA) involvement ≥ 10%, and an Investigator's Global Assessment (IGA) score (5-point scale) ≥ 3 at baseline.
5. Participants with a history of inadequate response to topical treatment, use of systemic treatments to treat AD, and/or for whom topical treatments are otherwise medically inadvisable.
6. Daily use of non-medicated emollient for at least 7 days prior to baseline.
Exclusion Criteria
2. Prior exposure to an anti-interleukin (IL)-33 antibody.
3. Exposure to an investigational or licensed or other anti T-helper 2 (Th2) type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer.
4. History of prior exposure to any investigational or biologic systemic treatment within 5 half lives of the screening or is currently enrolled in another clinical study.
5. Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening.
6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
18 Years
75 Years
ALL
No
Sponsors
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AnaptysBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Randazzo, MD
Role: STUDY_DIRECTOR
AnaptysBio, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Encino Research Group
Encino, California, United States
Irvine Center for Clinical Research, Inc.
Irvine, California, United States
Clinical Science Institute
Santa Monica, California, United States
Medical Research Center of Miami
Miami, Florida, United States
Compass Research Main
Orlando, Florida, United States
Moore Clinical Research Inc. - Brandon
Tampa, Florida, United States
Georgia Pollens Clinical Research Centers, Inc.
Albany, Georgia, United States
Dermatologic Surgery Specialists
Macon, Georgia, United States
Marietta Dermatology & The Skin Cancer Center - Marietta
Marietta, Georgia, United States
Advanced Medical Research, PC
Sandy Springs, Georgia, United States
Midwest Allergy, Sinus and Asthma, SC
Normal, Illinois, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Grekin Skin Institute - Warren
Warren, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Skin Specialists, PC
Omaha, Nebraska, United States
JDR Dermatology Research
Las Vegas, Nevada, United States
The Dermatology Group
Verona, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Forest Hills Dermatology Group
Forest Hills, New York, United States
SRG
New York, New York, United States
DermResearch Center of New York
Stony Brook, New York, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Ohio State University Clinical Trials Management Office
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Coppell Allergy and Asthma PA
Coppell, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Center for Medical Research
Houston, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Alberta DermaSurgery Centre
Edmonton, Alberta, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
ICLS Dermatology and Plastic Surgery
Oakville, Ontario, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
Windsor Clinical Research Inc.
Windsor, Ontario, Canada
Le centre de Recherche en Dermatologie du Drummondville
Drummondville, Quebec, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, Canada
CCR Brno, s.r.o.
Brno, , Czechia
CCR Czech, a.s.
Pardubice, , Czechia
CLINTRIAL s.r.o.
Prague, , Czechia
Dermatovenereology
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
Ústí nad Labem, , Czechia
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Klinikum der Ludwigs-Maximilians-Universitaet Muenchen
Munich, Bavaria, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, Hesse, Germany
Fachklinik Bad Bentheim Dermatologie
Bad Bentheim, Lower Saxony, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Lower Saxony, Germany
Universitaetsklinikum Bonn AoeR
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera gGmbH
Gera, Thuringia, Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, , Germany
Praxis fuer Haut- und Geschlechtskrankheiten
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
ClinicMed Daniluk, Nowak Spółka Jawna
Bialystok, , Poland
Centrum Badan Klinicznych P.I. House Sp. z o.o.
Gdansk, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Centrum Medyczne All-Med
Krakow, , Poland
Dermoklinika
Lodz, , Poland
NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
Lodz, , Poland
KO-MED Centra Kliniczne Lublin II
Lublin, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
Lublin, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
Laser Clinic S.C.
Szczecin, , Poland
Nasz Lekarz Przychodnie Medyczne
Torun, , Poland
Clinical Research Group Sp. z o.o.
Warsaw, , Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, , Poland
MAC UK Neurosciences Ltd / MAC Clinical Research
Manchester, Greater Manchester, United Kingdom
MAC UK Neuroscience Ltd / MAC Clinical Research Ltd
Cannock, Staffordshire, United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2018-000331-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANB020-005
Identifier Type: -
Identifier Source: org_study_id
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