Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

NCT03533751 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: ANB020-0052018-000331-27
• Study Type: interventional
• Target: 302
• Locations: 6 countries
• Sites: 81

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).

Conditions

Atopic Dermatitis

Keywords

ANB020; etokimab; eczema; moderate to severe

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score

  EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).

  Baseline and Week 16

Secondary Outcomes (10)

• Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16

  Baseline and Week 16

• Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16

  Baseline and Week 16

• Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16

  Baseline and Week 16

• 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

  Baseline and Week 16

• Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16

  Week 16

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.

Drug: Placebo

Etokimab 20 mg SC Q4W

EXPERIMENTAL

Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.

Biological: Etokimab

Etokimab 300 mg load + 150 mg SC Q8W

EXPERIMENTAL

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.

Biological: Etokimab; Drug: Placebo

Etokimab 300 mg load + 150 mg SC Q4W

EXPERIMENTAL

Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.

Biological: Etokimab

Etokimab 600 mg load + 300 mg SC Q4W

EXPERIMENTAL

Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.

Biological: Etokimab

Interventions

Etokimab BIOLOGICAL

Humanized monoclonal antibody, administered by subcutaneous injection

Also known as: ANB020

Etokimab 20 mg SC Q4W; Etokimab 300 mg load + 150 mg SC Q4W; Etokimab 300 mg load + 150 mg SC Q8W; Etokimab 600 mg load + 300 mg SC Q4W

Placebo DRUG

Administered by subcutaneous injection

Etokimab 300 mg load + 150 mg SC Q8W; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants must be 18 to 75 years of age, at the time of signing the informed consent.
• Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m\^2) at screening.
• Clinically confirmed diagnosis of AD.
• 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.
• 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.
• Daily use of non-medicated emollient for at least 7 days prior to baseline.

You may not qualify if:

• Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
• Prior exposure to an anti-interleukin (IL)-33 antibody.
• 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.
• 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.
• 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.
• History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.

Sponsors & Collaborators

• AnaptysBio, Inc.: lead

Study Sites (81)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Encino Research Group

Encino, California, 91436, United States

Location

Irvine Center for Clinical Research, Inc.

Irvine, California, 92614, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Medical Research Center of Miami

Miami, Florida, 33134, United States

Location

Compass Research Main

Orlando, Florida, 32806, United States

Location

Moore Clinical Research Inc. - Brandon

Tampa, Florida, 33609, United States

Location

Georgia Pollens Clinical Research Centers, Inc.

Albany, Georgia, 31707, United States

Location

Dermatologic Surgery Specialists

Macon, Georgia, 31217, United States

Location

Marietta Dermatology & The Skin Cancer Center - Marietta

Marietta, Georgia, 30060-1047, United States

Location

Advanced Medical Research, PC

Sandy Springs, Georgia, 30328, United States

Location

Midwest Allergy, Sinus and Asthma, SC

Normal, Illinois, 61761, United States

Location

Kansas City Dermatology, PA

Overland Park, Kansas, 66215-2314, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5400, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Grekin Skin Institute - Warren

Warren, Michigan, 48088, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63141, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

The Dermatology Group

Verona, New Jersey, 07044-2946, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

SRG

New York, New York, 10021, United States

Location

DermResearch Center of New York

Stony Brook, New York, 11790, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28403, United States

Location

Ohio State University Clinical Trials Management Office

Columbus, Ohio, 43210, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Coppell Allergy and Asthma PA

Coppell, Texas, 75019, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Center for Medical Research

Houston, Texas, 77056, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78213, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23220, United States

Location

Alberta DermaSurgery Centre

Edmonton, Alberta, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

ICLS Dermatology and Plastic Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

Ottawa Allergy Research Corporation

Ottawa, Ontario, K1G 6C6, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Le centre de Recherche en Dermatologie du Drummondville

Drummondville, Quebec, J2B 5L4, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

CCR Brno, s.r.o.

Brno, Czechia

Location

CCR Czech, a.s.

Pardubice, Czechia

Location

CLINTRIAL s.r.o.

Prague, Czechia

Location

Dermatovenereology

Prague, Czechia

Location

Fakultni nemocnice v Motole

Prague, Czechia

Location

Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.

Ústí nad Labem, Czechia

Location

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum der Ludwigs-Maximilians-Universitaet Muenchen

Munich, Bavaria, 80337, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, 60590, Germany

Location

Fachklinik Bad Bentheim Dermatologie

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Lower Saxony, 1307, Germany

Location

Universitaetsklinikum Bonn AoeR

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Universitaetsklinikum Leipzig AoeR

Leipzig, Saxony, 4103, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitaetsklinikum Schleswig Holstein - Campus Luebeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

SRH Wald-Klinikum Gera gGmbH

Gera, Thuringia, 7548, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117, Germany

Location

Praxis fuer Haut- und Geschlechtskrankheiten

Berlin, 13055, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

ClinicMed Daniluk, Nowak Spółka Jawna

Bialystok, Poland

Location

Centrum Badan Klinicznych P.I. House Sp. z o.o.

Gdansk, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Centrum Medyczne All-Med

Krakow, Poland

Location

Dermoklinika

Lodz, Poland

Location

NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

Lodz, Poland

Location

KO-MED Centra Kliniczne Lublin II

Lublin, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"

Lublin, Poland

Location

Centrum Medyczne Medyk

Rzeszów, Poland

Location

Laser Clinic S.C.

Szczecin, Poland

Location

Nasz Lekarz Przychodnie Medyczne

Torun, Poland

Location

Clinical Research Group Sp. z o.o.

Warsaw, Poland

Location

Wojewodzki Szpital Specjalistyczny we Wroclawiu

Wroclaw, Poland

Location

MAC UK Neurosciences Ltd / MAC Clinical Research

Manchester, Greater Manchester, M13 9NQ, United Kingdom

Location

MAC UK Neuroscience Ltd / MAC Clinical Research Ltd

Cannock, Staffordshire, WS11 0BN, United Kingdom

Location

Ninewells Hospital

Dundee, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Project Leader
• Organization: AnaptysBio, Inc.

info@anaptysbio.com

858-362-6295

Study Officials

• Bruce Randazzo, MD

  AnaptysBio, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 23, 2018
• Study Start: June 19, 2018
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (13); PL (13); US (37); GB (5); CA (7); CZ (6)