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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Etokimab
Placebo
Sponsored by
AnaptysBio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring ANB020, etokimab, eczema, moderate to severe

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female subjects 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 kg/m2 at screening.
  3. Clinically confirmed diagnosis 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. Subjects 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-IL-33 antibody.
  3. Exposure to an investigational or licensed or other anti 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.

Sites / Locations

  • University of Alabama at Birmingham
  • Applied Research Center of Arkansas
  • Encino Research Group
  • Irvine Center for Clinical Research, Inc.
  • Clinical Science Institute
  • Medical Research Center of Miami
  • Compass Research Main
  • Moore Clinical Research Inc. - Brandon
  • Georgia Pollens Clinical Research Centers, Inc.
  • Dermatologic Surgery Specialists
  • Marietta Dermatology & The Skin Cancer Center - Marietta
  • Advanced Medical Research, PC
  • Midwest Allergy, Sinus and Asthma, SC
  • Kansas City Dermatology, PA
  • DermResearch, PLLC
  • Beth Israel Deaconess Medical Center
  • Great Lakes Research Group, Inc.
  • Grekin Skin Institute - Warren
  • Washington University School of Medicine
  • Skin Specialists, PC
  • JDR Dermatology Research
  • The Dermatology Group
  • Albuquerque Clinical Trials, Inc.
  • Forest Hills Dermatology Group
  • SRG
  • DermResearch Center of New York
  • Wilmington Dermatology Center
  • Ohio State University Clinical Trials Management Office
  • Lynn Health Science Institute
  • Vital Prospects Clinical Research Institute, P.C.
  • Clinical Research Institute of Southern Oregon, PC
  • Clinical Partners, LLC
  • Coppell Allergy and Asthma PA
  • Dermatology Treatment and Research Center
  • Center for Medical Research
  • Progressive Clinical Research, PA
  • Clinical Research Partners, LLC
  • Alberta DermaSurgery Centre
  • Lynderm Research Inc.
  • ICLS Dermatology and Plastic Surgery
  • Ottawa Allergy Research Corporation
  • Windsor Clinical Research Inc.
  • Le centre de Recherche en Dermatologie du Drummondville
  • Centre de Recherche Dermatologique du Quebec Metropolitain
  • CCR Brno, s.r.o.
  • CCR Czech, a.s.
  • Fakultni nemocnice v Motole
  • CLINTRIAL s.r.o.
  • Dermatovenereology
  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
  • Universitaetsklinikum Tuebingen
  • Klinikum der Ludwigs-Maximilians-Universitaet Muenchen
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Fachklinik Bad Bentheim Dermatologie
  • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Universitaetsklinikum Bonn AoeR
  • Universitaetsklinikum Leipzig AoeR
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck
  • SRH Wald-Klinikum Gera gGmbH
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Praxis fuer Haut- und Geschlechtskrankheiten
  • Universitaetsklinikum Hamburg-Eppendorf
  • ClinicMed Daniluk, Nowak Spółka Jawna
  • Uniwersyteckie Centrum Kliniczne
  • Centrum Badan Klinicznych P.I. House Sp. z o.o.
  • Centrum Medyczne All-Med
  • KO-MED Centra Kliniczne Lublin II
  • Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
  • Centrum Medyczne Medyk
  • Laser Clinic S.C.
  • Nasz Lekarz Przychodnie Medyczne
  • Clinical Research Group Sp. z o.o.
  • Wojewodzki Szpital Specjalistyczny we Wroclawiu
  • Dermoklinika
  • NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
  • MAC UK Neurosciences Ltd / MAC Clinical Research
  • MAC UK Neuroscience Ltd / MAC Clinical Research Ltd
  • Ninewells Hospital
  • Royal Victoria Infirmary
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Etokimab 20 mg SC Q4W

Etokimab 300 mg load + 150 mg SC Q8W

Etokimab 300 mg load + 150 mg SC Q4W

Etokimab 600 mg load + 300 mg SC Q4W

Arm Description

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

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

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.

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
April 27, 2018
Last Updated
April 26, 2023
Sponsor
AnaptysBio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03533751
Brief Title
Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Acronym
ATLAS
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
December 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnaptysBio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
ANB020, etokimab, eczema, moderate to severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.
Arm Title
Etokimab 20 mg SC Q4W
Arm Type
Experimental
Arm Description
Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.
Arm Title
Etokimab 300 mg load + 150 mg SC Q8W
Arm Type
Experimental
Arm Description
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.
Arm Title
Etokimab 300 mg load + 150 mg SC Q4W
Arm Type
Experimental
Arm Description
Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.
Arm Title
Etokimab 600 mg load + 300 mg SC Q4W
Arm Type
Experimental
Arm Description
Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Intervention Type
Biological
Intervention Name(s)
Etokimab
Other Intervention Name(s)
ANB020
Intervention Description
Humanized monoclonal antibody, administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
Description
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).
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16
Description
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).
Time Frame
Baseline and Week 16
Title
Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16
Description
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).
Time Frame
Baseline and Week 16
Title
Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16
Description
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).
Time Frame
Baseline and Week 16
Title
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
Description
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.
Time Frame
Baseline and Week 16
Title
Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16
Description
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.
Time Frame
Week 16
Title
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
Description
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.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
Description
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).
Time Frame
Baseline and Week 16
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
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.
Time Frame
From first dose to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Randazzo, MD
Organizational Affiliation
AnaptysBio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Encino Research Group
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Irvine Center for Clinical Research, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Medical Research Center of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Compass Research Main
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Moore Clinical Research Inc. - Brandon
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Georgia Pollens Clinical Research Centers, Inc.
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Dermatologic Surgery Specialists
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Marietta Dermatology & The Skin Cancer Center - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1047
Country
United States
Facility Name
Advanced Medical Research, PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Midwest Allergy, Sinus and Asthma, SC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Kansas City Dermatology, PA
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215-2314
Country
United States
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Grekin Skin Institute - Warren
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
JDR Dermatology Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
The Dermatology Group
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044-2946
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Forest Hills Dermatology Group
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
SRG
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
DermResearch Center of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Ohio State University Clinical Trials Management Office
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Coppell Allergy and Asthma PA
City
Coppell
State/Province
Texas
ZIP/Postal Code
75019
Country
United States
Facility Name
Dermatology Treatment and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Center for Medical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Alberta DermaSurgery Centre
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
ICLS Dermatology and Plastic Surgery
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Ottawa Allergy Research Corporation
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Facility Name
Windsor Clinical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Le centre de Recherche en Dermatologie du Drummondville
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 5L4
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec Metropolitain
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
CCR Brno, s.r.o.
City
Brno
Country
Czechia
Facility Name
CCR Czech, a.s.
City
Pardubice
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Prague
Country
Czechia
Facility Name
CLINTRIAL s.r.o.
City
Praha 10
Country
Czechia
Facility Name
Dermatovenereology
City
Praha
Country
Czechia
Facility Name
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
City
Ústí Nad Labem
Country
Czechia
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
State/Province
Baden Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum der Ludwigs-Maximilians-Universitaet Muenchen
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Fachklinik Bad Bentheim Dermatologie
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
State/Province
Niedersachsen
ZIP/Postal Code
1307
Country
Germany
Facility Name
Universitaetsklinikum Bonn AoeR
City
Bonn
State/Province
Nordrhein Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitaetsklinikum Leipzig AoeR
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
4103
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
State/Province
Schleswig Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
City
Luebeck
State/Province
Schleswig Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
SRH Wald-Klinikum Gera gGmbH
City
Gera
State/Province
Thueringen
ZIP/Postal Code
7548
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis fuer Haut- und Geschlechtskrankheiten
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
ClinicMed Daniluk, Nowak Spółka Jawna
City
Bialystok
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
Country
Poland
Facility Name
Centrum Badan Klinicznych P.I. House Sp. z o.o.
City
Gdańsk
Country
Poland
Facility Name
Centrum Medyczne All-Med
City
Kraków
Country
Poland
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
City
Lublin
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszów
Country
Poland
Facility Name
Laser Clinic S.C.
City
Szczecin
Country
Poland
Facility Name
Nasz Lekarz Przychodnie Medyczne
City
Toruń
Country
Poland
Facility Name
Clinical Research Group Sp. z o.o.
City
Warszawa
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny we Wroclawiu
City
Wrocław
Country
Poland
Facility Name
Dermoklinika
City
Łódź
Country
Poland
Facility Name
NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
City
Łódź
Country
Poland
Facility Name
MAC UK Neurosciences Ltd / MAC Clinical Research
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
MAC UK Neuroscience Ltd / MAC Clinical Research Ltd
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.anaptysbio.com
Description
Related Info
URL
http://www.atlasatopicdermatitisstudy.com
Description
Related Info

Learn more about this trial

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

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