Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: EtokimabDrug: Placebo
- Registration Number
- NCT03533751
- Lead Sponsor
- AnaptysBio, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Etokimab 20 mg SC Q4W Etokimab Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks. Etokimab 300 mg load + 150 mg SC Q8W Etokimab 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 600 mg load + 300 mg SC Q4W Etokimab Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. Placebo Placebo Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks. Etokimab 300 mg load + 150 mg SC Q8W Placebo 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 300 mg load + 150 mg SC Q4W Etokimab Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score Baseline and 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).
- Secondary Outcome Measures
Name Time Method 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 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 ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16 Baseline and 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 Baseline and 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.
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 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
1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting
2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting
3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present
4. 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 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
1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting
2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting
3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present
4. 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.Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 Baseline and 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) From first dose to Week 24 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.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 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).
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16 Baseline and 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).
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 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).
Trial Locations
- Locations (81)
Ohio State University Clinical Trials Management Office
🇺🇸Columbus, Ohio, United States
Laser Clinic S.C.
🇵🇱Szczecin, Poland
Clinical Research Group Sp. z o.o.
🇵🇱Warszawa, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
🇵🇱Wrocław, Poland
Dermoklinika
🇵🇱Łódź, Poland
Medical Research Center of Miami
🇺🇸Miami, Florida, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
SRG
🇺🇸New York, New York, United States
Irvine Center for Clinical Research, Inc.
🇺🇸Irvine, California, United States
Grekin Skin Institute - Warren
🇺🇸Warren, Michigan, United States
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Baden Wuerttemberg, Germany
KO-MED Centra Kliniczne Lublin II
🇵🇱Lublin, Poland
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Dermatovenereology
🇨🇿Praha, Czechia
Centrum Badan Klinicznych P.I. House Sp. z o.o.
🇵🇱Gdańsk, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"
🇵🇱Lublin, Poland
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
🇩🇪Berlin, Germany
Praxis fuer Haut- und Geschlechtskrankheiten
🇩🇪Berlin, Germany
Universitaetsklinikum Leipzig AoeR
🇩🇪Leipzig, Sachsen, Germany
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
🇨🇿Ústí Nad Labem, Czechia
SRH Wald-Klinikum Gera gGmbH
🇩🇪Gera, Thueringen, Germany
Centrum Medyczne All-Med
🇵🇱Kraków, Poland
Nasz Lekarz Przychodnie Medyczne
🇵🇱Toruń, Poland
ClinicMed Daniluk, Nowak Spółka Jawna
🇵🇱Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Centrum Medyczne Medyk
🇵🇱Rzeszów, Poland
Fachklinik Bad Bentheim Dermatologie
🇩🇪Bad Bentheim, Niedersachsen, Germany
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Klinikum der Ludwigs-Maximilians-Universitaet Muenchen
🇩🇪Muenchen, Bayern, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Hessen, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
🇩🇪Dresden, Niedersachsen, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
🇩🇪Kiel, Schleswig Holstein, Germany
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
🇩🇪Luebeck, Schleswig Holstein, Germany
Advanced Medical Research, PC
🇺🇸Sandy Springs, Georgia, United States
Encino Research Group
🇺🇸Encino, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Dermatologic Surgery Specialists
🇺🇸Macon, Georgia, United States
Georgia Pollens Clinical Research Centers, Inc.
🇺🇸Albany, Georgia, United States
Marietta Dermatology & The Skin Cancer Center - Marietta
🇺🇸Marietta, Georgia, United States
Midwest Allergy, Sinus and Asthma, SC
🇺🇸Normal, Illinois, United States
Kansas City Dermatology, PA
🇺🇸Overland Park, Kansas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Forest Hills Dermatology Group
🇺🇸Forest Hills, New York, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
DermResearch Center of New York
🇺🇸Stony Brook, New York, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Wilmington Dermatology Center
🇺🇸Wilmington, North Carolina, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
Center for Medical Research
🇺🇸Houston, Texas, United States
Coppell Allergy and Asthma PA
🇺🇸Coppell, Texas, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Windsor Clinical Research Inc.
🇨🇦Windsor, Ontario, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
ICLS Dermatology and Plastic Surgery
🇨🇦Oakville, Ontario, Canada
Ottawa Allergy Research Corporation
🇨🇦Ottawa, Ontario, Canada
CCR Czech, a.s.
🇨🇿Pardubice, Czechia
CLINTRIAL s.r.o.
🇨🇿Praha 10, Czechia
CCR Brno, s.r.o.
🇨🇿Brno, Czechia
Fakultni nemocnice v Motole
🇨🇿Prague, Czechia
Universitaetsklinikum Bonn AoeR
🇩🇪Bonn, Nordrhein Westfalen, Germany
MAC UK Neurosciences Ltd / MAC Clinical Research
🇬🇧Manchester, Greater Manchester, United Kingdom
NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie
🇵🇱Łódź, Poland
MAC UK Neuroscience Ltd / MAC Clinical Research Ltd
🇬🇧Cannock, Staffordshire, United Kingdom
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Compass Research Main
🇺🇸Orlando, Florida, United States
DermResearch, PLLC
🇺🇸Louisville, Kentucky, United States
Moore Clinical Research Inc. - Brandon
🇺🇸Tampa, Florida, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
JDR Dermatology Research
🇺🇸Las Vegas, Nevada, United States
The Dermatology Group
🇺🇸Verona, New Jersey, United States
Centre de Recherche Dermatologique du Quebec Metropolitain
🇨🇦Québec, Quebec, Canada
Alberta DermaSurgery Centre
🇨🇦Edmonton, Alberta, Canada
Le centre de Recherche en Dermatologie du Drummondville
🇨🇦Drummondville, Quebec, Canada