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A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe AD (ATLAS)

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ClinicalTrials.gov Identifier: NCT03533751
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

Brief Summary:
This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of ANB020 in subjects with atopic dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: etokimab (ANB020) Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Solution

Experimental: Group 1
etokimab (ANB020)
Biological: etokimab (ANB020)
Humanized Monoclonal Antibody

Experimental: Group 2
etokimab (ANB020)
Biological: etokimab (ANB020)
Humanized Monoclonal Antibody

Experimental: Group 3
etokimab (ANB020)
Biological: etokimab (ANB020)
Humanized Monoclonal Antibody

Experimental: Group 4
etokimab (ANB020)
Biological: etokimab (ANB020)
Humanized Monoclonal Antibody




Primary Outcome Measures :
  1. Percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Safety of ANB020 in adult patients with moderate to severe atopic dermatitis. [ Time Frame: Week 16 ]
    Number of participants with treatment-related adverse events.

  2. Proportion of subjects who achieve Investigator's Global Assessment (IGA) response of 0 (clear) or 1 (almost clear) [ Time Frame: Week 16 ]
  3. Proportion of subjects who achieve IGA Score reduction of ≥2 [ Time Frame: Week 16 ]
  4. Percent change in peak weekly averaged numerical rating scale (NRS) for pruritus score from baseline [ Time Frame: Week 16 ]
  5. Proportion of subjects who achieve weekly averaged NRS score reduction from baseline of ≥3 [ Time Frame: Week 16 ]
  6. Proportion of subjects with EASI 50 (≥50% improvement from baseline). [ Time Frame: Week 16 ]
  7. Proportion of subjects with EASI 75 (≥75% improvement from baseline). [ Time Frame: Week 16 ]
  8. Percent change in EASI score from baseline to clinical assessment time points prior to Week 16 [ Time Frame: Through Week 16 ]
  9. Absolute change in EASI score from baseline. [ Time Frame: Week 16 ]
  10. Percent change in percent Body Surface Area (BSA) from baseline [ Time Frame: Week 16 ]
  11. Absolute change in percent BSA from baseline [ Time Frame: Week 16 ]
  12. Percent change in Scoring Atopic Dermatitis (SCORAD) score from baseline. [ Time Frame: Week 16 ]
  13. Absolute change in SCORAD scores from baseline. [ Time Frame: Week 16 ]

Other Outcome Measures:
  1. Cmax - peak ANB020 concentration in serum following multiple dose administration [ Time Frame: Through study completion, Week 24 ]
  2. Ctrough - trough ANB020 concentration in serum [ Time Frame: Through study completion, Week 24 ]
  3. Clast - last positive (quantifiable) ANB020 concentration in serum [ Time Frame: Through study completion, Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533751


Contacts
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Contact: AnaptysBio, Inc 858-362-6295 ANB020-005@anaptysbio.com

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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
United States, Arkansas
Applied Research Center of Arkansas Recruiting
Little Rock, Arkansas, United States, 72212
United States, California
Encino Research Group Recruiting
Encino, California, United States, 91436
Irvine Center for Clinical Research, Inc. Recruiting
Irvine, California, United States, 92614
Clinical Science Institute Recruiting
Santa Monica, California, United States, 90404
United States, Florida
Medical Research Center of Miami Recruiting
Miami, Florida, United States, 33134
FXM Research Withdrawn
Miami, Florida, United States, 33175
FXM Research Miramar Withdrawn
Miramar, Florida, United States, 33027
Compass Research Main Recruiting
Orlando, Florida, United States, 32806
Moore Clinical Research Inc. - Brandon Recruiting
Tampa, Florida, United States, 33609
Palm Beach Research Center Withdrawn
West Palm Beach, Florida, United States, 33409
United States, Georgia
Georgia Pollens Clinical Research Centers, Inc. Recruiting
Albany, Georgia, United States, 31707
Dermatologic Surgery Specialists Recruiting
Macon, Georgia, United States, 31217
Marietta Dermatology & The Skin Cancer Center - Marietta Recruiting
Marietta, Georgia, United States, 30060-1047
Advanced Medical Research, PC Recruiting
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Midwest Allergy, Sinus and Asthma, SC Recruiting
Normal, Illinois, United States, 61761
United States, Kansas
Kansas City Dermatology, PA Recruiting
Overland Park, Kansas, United States, 66215-2314
United States, Kentucky
DermResearch, PLLC Recruiting
Louisville, Kentucky, United States, 40217
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215-5400
United States, Michigan
Great Lakes Research Group, Inc. Recruiting
Bay City, Michigan, United States, 48706
Grekin Skin Institute - Warren Recruiting
Warren, Michigan, United States, 48088
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Skin Specialists, PC Recruiting
Omaha, Nebraska, United States, 68144
United States, Nevada
JDR Dermatology Research Recruiting
Las Vegas, Nevada, United States, 89148
United States, New Jersey
The Dermatology Group Recruiting
Verona, New Jersey, United States, 07044-2946
United States, New Mexico
Albuquerque Clinical Trials, Inc. Recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
Forest Hills Dermatology Group Recruiting
Forest Hills, New York, United States, 11375
SRG Recruiting
New York, New York, United States, 10021
DermResearch Center of New York Recruiting
Stony Brook, New York, United States, 11790
United States, North Carolina
Wilmington Dermatology Center Recruiting
Wilmington, North Carolina, United States, 28403
United States, Ohio
Ohio State University Clinical Trials Management Office Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Lynn Health Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
Vital Prospects Clinical Research Institute, P.C. Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Clinical Research Institute of Southern Oregon, PC Recruiting
Medford, Oregon, United States, 97504
United States, Rhode Island
Clinical Partners, LLC Recruiting
Johnston, Rhode Island, United States, 02919
United States, Texas
Coppell Allergy and Asthma PA Recruiting
Coppell, Texas, United States, 75019
Dermatology Treatment and Research Center Recruiting
Dallas, Texas, United States, 75230
Center for Medical Research Recruiting
Houston, Texas, United States, 77056
Progressive Clinical Research, PA Recruiting
San Antonio, Texas, United States, 78213
United States, Virginia
Clinical Research Partners, LLC Recruiting
Richmond, Virginia, United States, 23220
Canada, Alberta
Alberta DermaSurgery Centre Recruiting
Edmonton, Alberta, Canada
Canada, Ontario
Lynderm Research Inc. Recruiting
Markham, Ontario, Canada, L3P 1X2
ICLS Dermatology and Plastic Surgery Recruiting
Oakville, Ontario, Canada, L6J 7W5
Ottawa Allergy Research Corporation Recruiting
Ottawa, Ontario, Canada, K1G 6C6
Windsor Clinical Research Inc. Recruiting
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Le centre de Recherche en Dermatologie du Drummondville Recruiting
Drummondville, Quebec, Canada, J2B 5L4
Centre de Recherche Dermatologique du Quebec Metropolitain Recruiting
Québec, Quebec, Canada, G1V 4X7
Czechia
CCR Brno, s.r.o. Recruiting
Brno, Czechia
CCR Czech, a.s. Recruiting
Pardubice, Czechia
Fakultni nemocnice v Motole Recruiting
Prague, Czechia
CLINTRIAL s.r.o. Recruiting
Praha 10, Czechia
Dermatovenereology Recruiting
Praha, Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z. Recruiting
Ústí Nad Labem, Czechia
Germany
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Baden Wuerttemberg, Germany, 72076
Klinikum der Ludwigs-Maximilians-Universitaet Muenchen Recruiting
Muenchen, Bayern, Germany, 80337
Klinikum der Johann Wolfgang Goethe-Universitaet Recruiting
Frankfurt, Hessen, Germany, 60590
Fachklinik Bad Bentheim Dermatologie Recruiting
Bad Bentheim, Niedersachsen, Germany, 48455
Universitaetsklinikum Carl Gustav Carus TU Dresden Recruiting
Dresden, Niedersachsen, Germany, 1307
Universitaetsklinikum Bonn AoeR Recruiting
Bonn, Nordrhein Westfalen, Germany, 53105
Universitaetsklinikum Leipzig AoeR Recruiting
Leipzig, Sachsen, Germany, 4103
Universitaetsklinikum Schleswig-Holstein - Campus Kiel Recruiting
Kiel, Schleswig Holstein, Germany, 24105
Universitaetsklinikum Schleswig Holstein - Campus Luebeck Recruiting
Luebeck, Schleswig Holstein, Germany, 23538
SRH Wald-Klinikum Gera gGmbH Recruiting
Gera, Thueringen, Germany, 7548
Charite Universitaetsmedizin Berlin - Campus Charite Mitte Recruiting
Berlin, Germany, 10117
Praxis fuer Haut- und Geschlechtskrankheiten Recruiting
Berlin, Germany, 13055
Universitaetsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Poland
ClinicMed Daniluk, Nowak Spółka Jawna Recruiting
Bialystok, Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland
Centrum Badan Klinicznych P.I. House Sp. z o.o. Recruiting
Gdańsk, Poland
Centrum Medyczne All-Med Recruiting
Kraków, Poland
KO-MED Centra Kliniczne Lublin II Recruiting
Lublin, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser" Recruiting
Lublin, Poland
Centrum Medyczne Medyk Recruiting
Rzeszów, Poland
Laser Clinic S.C. Recruiting
Szczecin, Poland
Nasz Lekarz Przychodnie Medyczne Recruiting
Toruń, Poland
Clinical Research Group Sp. z o.o. Recruiting
Warszawa, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu Recruiting
Wrocław, Poland
Dermoklinika Recruiting
Łódź, Poland
NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie Recruiting
Łódź, Poland
United Kingdom
MAC UK Neurosciences Ltd / MAC Clinical Research Recruiting
Manchester, Greater Manchester, United Kingdom, M13 9NQ
MAC UK Neuroscience Ltd / MAC Clinical Research Ltd Recruiting
Cannock, Staffordshire, United Kingdom, WS11 0BN
Ninewells Hospital Recruiting
Dundee, United Kingdom
Royal Victoria Infirmary Recruiting
Newcastle Upon Tyne, United Kingdom
Churchill Hospital Recruiting
Oxford, United Kingdom
Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
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Study Director: Marco Londei, M.D. AnaptysBio, Inc.

Additional Information:
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Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT03533751     History of Changes
Other Study ID Numbers: ANB020-005
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AnaptysBio, Inc.:
ANB020
etokimab
eczema
moderate to severe

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases