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

April 26, 2023 updated by: AnaptysBio, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
Time Frame: 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).
Baseline and Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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.
Baseline and Week 16
Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16
Time Frame: 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.
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
Time Frame: 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.
Baseline and Week 16
Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16
Time Frame: 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.
Baseline and Week 16
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
Time Frame: 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).
Baseline and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Time Frame: 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.
Baseline and Week 16
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: 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.
From first dose to Week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Cmax - peak ANB020 concentration in serum following multiple dose administration
Time Frame: Through study completion, Week 24
Through study completion, Week 24
Ctrough - trough ANB020 concentration in serum
Time Frame: Through study completion, Week 24
Through study completion, Week 24
Clast - last positive (quantifiable) ANB020 concentration in serum
Time Frame: Through study completion, Week 24
Through study completion, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AnaptysBio, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bruce Randazzo, MD, AnaptysBio, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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