Clinical trial NCT03533751: Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: ANB020
etokimab
eczema
moderate to severe
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of etokimab in adult participants with atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

1. Male or female participants must be 18 to 75 years of age, at the time of signing the informed consent.
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:

1. Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants Who Achieved a Reduction of ≥ 2 Points From Baseline in the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16
timeFrame: Week 16
measure: Number of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: From first dose to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Encino
country: United States
facility: Encino Research Group
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research, Inc.
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Miami
country: United States
facility: Medical Research Center of Miami
state: Florida
city: Orlando
country: United States
facility: Compass Research Main
state: Florida
city: Tampa
country: United States
facility: Moore Clinical Research Inc. - Brandon
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc.
state: Georgia
city: Macon
country: United States
facility: Dermatologic Surgery Specialists
state: Georgia
city: Marietta
country: United States
facility: Marietta Dermatology & The Skin Cancer Center - Marietta
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC
state: Georgia
city: Normal
country: United States
facility: Midwest Allergy, Sinus and Asthma, SC
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute - Warren
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Las Vegas
country: United States
facility: JDR Dermatology Research
state: Nevada
city: Verona
country: United States
facility: The Dermatology Group
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: SRG
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York
state: New York
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Clinical Trials Management Office
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Coppell
country: United States
facility: Coppell Allergy and Asthma PA
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Houston
country: United States
facility: Center for Medical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: ICLS Dermatology and Plastic Surgery
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corporation
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research Inc.
state: Ontario
city: Drummondville
country: Canada
facility: Le centre de Recherche en Dermatologie du Drummondville
state: Quebec
city: Québec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain
state: Quebec
city: Brno
country: Czechia
facility: CCR Brno, s.r.o.
city: Pardubice
country: Czechia
facility: CCR Czech, a.s.
city: Prague
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha 10
country: Czechia
facility: CLINTRIAL s.r.o.
city: Praha
country: Czechia
facility: Dermatovenereology
city: Ústí Nad Labem
country: Czechia
facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden Wuerttemberg
city: Muenchen
country: Germany
facility: Klinikum der Ludwigs-Maximilians-Universitaet Muenchen
state: Bayern
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
state: Hessen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim Dermatologie
state: Niedersachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn AoeR
state: Nordrhein Westfalen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AoeR
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
state: Schleswig Holstein
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck
state: Schleswig Holstein
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera gGmbH
state: Thueringen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Berlin
country: Germany
facility: Praxis fuer Haut- und Geschlechtskrankheiten
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Spółka Jawna
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdańsk
country: Poland
facility: Centrum Badan Klinicznych P.I. House Sp. z o.o.
city: Kraków
country: Poland
facility: Centrum Medyczne All-Med
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Lublin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
city: Rzeszów
country: Poland
facility: Centrum Medyczne Medyk
city: Szczecin
country: Poland
facility: Laser Clinic S.C.
city: Toruń
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warszawa
country: Poland
facility: Clinical Research Group Sp. z o.o.
city: Wrocław
country: Poland
facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu
city: Łódź
country: Poland
facility: Dermoklinika
city: Łódź
country: Poland
facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
city: Manchester
country: United Kingdom
facility: MAC UK Neurosciences Ltd / MAC Clinical Research
state: Greater Manchester
city: Cannock
country: United Kingdom
facility: MAC UK Neuroscience Ltd / MAC Clinical Research Ltd
state: Staffordshire
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: AnaptysBio, Inc.
name: Bruce Randazzo, MD
role: STUDY_DIRECTOR
References: