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

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

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Biological: Etokimab

Detailed Description

This is a multi-center, 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
• Enrollment (Actual): 302
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Alberta Dermasurgery Centre
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc.
    • Oakville, Ontario, Canada, L6J 7W5
      • ICLS Dermatology and Plastic Surgery
    • Ottawa, Ontario, Canada, K1G 6C6
      • Ottawa Allergy Research Corporation
    • Windsor, Ontario, Canada, N8W 5L7
      • Windsor Clinical Research Inc.
  • Quebec
    • Drummondville, Quebec, Canada, J2B 5L4
      • Le centre de Recherche en Dermatologie du Drummondville
    • Québec, Quebec, Canada, G1V 4X7
      • Centre De Recherche Dermatologique Du Quebec Metropolitain
• Czechia
  • Brno, Czechia
    • CCR Brno, s.r.o.
  • Pardubice, Czechia
    • CCR Czech, a.s.
  • Prague, Czechia
    • Fakultni nemocnice v Motole
  • Praha, Czechia
    • Dermatovenereology
  • Praha 10, Czechia
    • CLINTRIAL s.r.o.
  • Ústí Nad Labem, Czechia
    • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Berlin, Germany, 13055
    • Praxis fuer Haut- und Geschlechtskrankheiten
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Baden Wuerttemberg
    • Tuebingen, Baden Wuerttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen
  • Bayern
    • Muenchen, Bayern, Germany, 80337
      • Klinikum der Ludwigs-Maximilians-Universitaet Muenchen
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Klinikum Der Johann Wolfgang Goethe-Universitaet
  • Niedersachsen
    • Bad Bentheim, Niedersachsen, Germany, 48455
      • Fachklinik Bad Bentheim Dermatologie
    • Dresden, Niedersachsen, Germany, 1307
      • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Nordrhein Westfalen
    • Bonn, Nordrhein Westfalen, Germany, 53105
      • Universitaetsklinikum Bonn AoeR
  • Sachsen
    • Leipzig, Sachsen, Germany, 4103
      • Universitaetsklinikum Leipzig AoeR
  • Schleswig Holstein
    • Kiel, Schleswig Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
    • Luebeck, Schleswig Holstein, Germany, 23538
      • Universitaetsklinikum Schleswig Holstein - Campus Luebeck
  • Thueringen
    • Gera, Thueringen, Germany, 7548
      • SRH Wald-Klinikum Gera gGmbH
• Poland
  • Bialystok, Poland
    • ClinicMed Daniluk, Nowak Spółka Jawna
  • Gdansk, Poland
    • Uniwersyteckie Centrum Kliniczne
  • Gdańsk, Poland
    • Centrum Badan Klinicznych P.I. House Sp. z o.o.
  • Kraków, Poland
    • Centrum Medyczne ALL-MED
  • Lublin, Poland
    • KO-MED Centra Kliniczne Lublin II
  • Lublin, Poland
    • Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
  • Rzeszów, Poland
    • Centrum Medyczne MEDYK
  • Szczecin, Poland
    • Laser Clinic S.C.
  • Toruń, Poland
    • Nasz Lekarz Przychodnie Medyczne
  • Warszawa, Poland
    • Clinical Research Group Sp. z o.o.
  • Wrocław, Poland
    • Wojewodzki Szpital Specjalistyczny We Wroclawiu
  • Łódź, Poland
    • Dermoklinika
  • Łódź, Poland
    • NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
• United Kingdom
  • Dundee, United Kingdom
    • Ninewells Hospital
  • Newcastle Upon Tyne, United Kingdom
    • Royal Victoria Infirmary
  • Oxford, United Kingdom
    • Churchill Hospital
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9NQ
      • MAC UK Neurosciences Ltd / MAC Clinical Research
  • Staffordshire
    • Cannock, Staffordshire, United Kingdom, WS11 0BN
      • MAC UK Neuroscience Ltd / MAC Clinical Research Ltd
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • California
    • Encino, California, United States, 91436
      • Encino Research Group
    • Irvine, California, United States, 92614
      • Irvine Center for Clinical Research, Inc.
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Miami, Florida, United States, 33134
      • Medical Research Center of Miami
    • Orlando, Florida, United States, 32806
      • Compass Research Main
    • Tampa, Florida, United States, 33609
      • Moore Clinical Research Inc. - Brandon
  • Georgia
    • Albany, Georgia, United States, 31707
      • Georgia Pollens Clinical Research Centers, Inc.
    • Macon, Georgia, United States, 31217
      • Dermatologic Surgery Specialists
    • Marietta, Georgia, United States, 30060-1047
      • Marietta Dermatology & The Skin Cancer Center - Marietta
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research, PC
  • Illinois
    • Normal, Illinois, United States, 61761
      • Midwest Allergy, Sinus and Asthma, SC
  • Kansas
    • Overland Park, Kansas, United States, 66215-2314
      • Kansas City Dermatology, PA
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch, PLLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute - Warren
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • JDR Dermatology Research
  • New Jersey
    • Verona, New Jersey, United States, 07044-2946
      • The Dermatology Group
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10021
      • SRG
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Clinical Trials Management Office
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Oregon
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of Southern Oregon, PC
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • Texas
    • Coppell, Texas, United States, 75019
      • Coppell Allergy and Asthma PA
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center
    • Houston, Texas, United States, 77056
      • Center for Medical Research
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research, PA
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Clinical Research Partners, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.	Drug: Placebo; Administered by subcutaneous injection
Experimental: Etokimab 20 mg SC Q4W; Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.	Biological: Etokimab; Humanized monoclonal antibody, administered by subcutaneous injection; Other Names: ANB020
Experimental: 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.	Drug: Placebo; Administered by subcutaneous injection; Biological: Etokimab; Humanized monoclonal antibody, administered by subcutaneous injection; Other Names: ANB020
Experimental: 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.	Biological: Etokimab; Humanized monoclonal antibody, administered by subcutaneous injection; Other Names: ANB020
Experimental: 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.	Biological: Etokimab; Humanized monoclonal antibody, administered by subcutaneous injection; Other Names: ANB020

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16	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
Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16	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
Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16	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
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	The vIGA-AD is a static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present; Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting; Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting; Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present; Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present. Number of participants with ≥2 points reduction in vIGA-AD is presented.	Baseline and Week 16
Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16	vIGA-AD is static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present; Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting; Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting; Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present; Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread. Oozing or crusting may be present Participants who achieved vIGA-AD response of 0 (clear) or 1 (almost clear) are reported.	Week 16
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	Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.	Baseline and Week 16
Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16	Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.	Baseline and Week 16
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as extent of disease (0 [no disease]-102 [worst disease]). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 (none) to 18 (severe intensity). Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (itch: 0 [no itch] to 10 [worst imaginable itch] and sleeplessness: 0 [no sleeplessness] to 10 [worst imaginable sleeplessness]) (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 (no AD present) to 103.4 (worst).	Baseline and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.	Baseline and Week 16
Number of Participants Who Experienced an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent adverse event (TEAE) is any AE that started or worsened in severity on or after the date and time of the study drug administration. A serious adverse event (SAE) is as any untoward medical occurrence that, at any dose: Resulted in death;; Was life-threatening;; Required inpatient hospitalization or prolongation of existing hospitalization;; Resulted in persistent disability/incapacity;; Was a congenital anomaly/birth defect.	From first dose to Week 24

Other Outcome Measures

Outcome Measure	Time Frame
Cmax - peak ANB020 concentration in serum following multiple dose administration	Through study completion, Week 24
Ctrough - trough ANB020 concentration in serum	Through study completion, Week 24
Clast - last positive (quantifiable) ANB020 concentration in serum	Through study completion, Week 24

Collaborators and Investigators

• Sponsor: AnaptysBio, Inc.
• Investigators: Study Director: Bruce Randazzo, MD, AnaptysBio, Inc.

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: eczema; moderate to severe; ANB020; etokimab
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ANB020-005; 2018-000331-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No