This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects with Moderate to Severe Atopic Dermatitis (AD).

February 12, 2025 updated by: AnaptysBio, Inc.

A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Subjects with Moderate to Severe Atopic Dermatitis

This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).

Study Overview

Status

Status

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

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 Phase 2, randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of ANB032 in subjects with moderate to severe atopic dermatitis (AD).

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.
201

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

  • Australia
      • Coorparoo, Australia, 4151
        • AnaptysBio Investigative Site 35-104
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • AnaptysBio Investigative Site 35-103
  • Canada
    • British Colombia
      • Surrey, British Colombia, Canada, V3V 0C6
        • AnaptysBio Investigative Site 11-105
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • AnaptysBio Investigative Site 11-102
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • AnaptysBio Investigative Site 11-106
      • London, Ontario, Canada, N6H 5L5
        • AnaptysBio Investigative Site 11-101
      • North Bay, Ontario, Canada, P1B327
        • AnaptysBio Investigative Site 11-103
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • AnaptysBio Investigative Site 11-107
  • Czechia
      • Pardubice, Czechia, 53002
        • AnaptysBio Investigative Site 57-104
      • Prague 1, Czechia, 11000
        • AnaptysBio Investigative Site 57-105
      • Prague 10, Czechia, 13000
        • AnaptysBio Investigative Site 57-102
      • Prague 5, Czechia, 1500
        • AnaptysBio Investigative Site 57-101
  • Georgia
      • Tbilisi, Georgia, 0112
        • AnaptysBio Investigative Site 59-105
      • Tbilisi, Georgia, 0114
        • AnaptysBio Investigative Site 59-106
      • Tbilisi, Georgia, 0141
        • AnaptysBio Investigative Site 59-101
      • Tbilisi, Georgia, 0160
        • AnaptysBio Investigative Site 59-102
      • Tbilisi, Georgia, 0160
        • AnaptysBio Investigative Site 59-103
      • Tbilisi, Georgia, 0160
        • AnaptysBio Investigative Site 59-104
      • Tbilisi, Georgia, 0179
        • AnaptysBio Investigative Site 59-107
  • New Zealand
      • Grafton, New Zealand, 1010
        • AnaptysBio Investigative Site 36-101
      • Nelson, New Zealand, 7011
        • AnaptysBio Investigative Site 36-104
      • Rosedale, New Zealand, 0632
        • AnaptysBio Investigative Site 36-102
      • Wellington, New Zealand, 6021
        • AnaptysBio Investigative Site 36-103
  • Poland
      • Bydgoszcz, Poland, 85-079
        • AnaptysBio Investigative Site 30-111
      • Częstochowa, Poland, 42-217
        • AnaptysBio Investigative Site 30-113
      • Gdańsk, Poland, 80-214
        • AnaptysBio Investigative Site 30-108
      • Kraków, Poland, 31-559
        • AnaptysBio Investigative Site 30-106
      • Rzeszów, Poland, 35-055
        • AnaptysBio Investigative Site 30-109
      • Skierniewice, Poland, 96-100
        • AnaptysBio Investigative Site 30-115
      • Szczecin, Poland, 70-332
        • AnaptysBio Investigative Site 30-112
      • Warsaw, Poland, 02-677
        • AnaptysBio Investigative Site 30-116
      • Warszawa, Poland, 00-874
        • AnaptysBio Investigative Site 30-105
      • Warszawa, Poland, 01-817
        • AnaptysBio Investigative Site 30-107
      • Wrocław, Poland, 50-566
        • AnaptysBio Investigative Site 30-104
      • Wrocław, Poland, 51-503
        • AnaptysBio Investigative Site 30-114
      • Łódź, Poland, 90-436
        • AnaptysBio Investigative Site 30-101
      • Świdnik, Poland, 21-040
        • AnaptysBio Investigative Site 30-102
  • United States
    • California
      • Anaheim, California, United States, 92801
        • AnaptysBio Investigative Site 10-140
      • Cerritos, California, United States, 90703
        • AnaptysBio Investigative Site 10-141
      • Fountain Valley, California, United States, 92708
        • AnaptysBio Investigative Site 10-121
      • Fremont, California, United States, 94538
        • AnaptysBio Investigative Site 10-107
      • Lancaster, California, United States, 93534
        • AnaptysBio Investigative Site 10-120
      • Lomita, California, United States, 90717
        • AnaptysBio Investigative 10-125
      • Oxnard, California, United States, 93030
        • AnaptysBio Investigative Site 10-146
      • Pasadena, California, United States, 91101
        • AnaptysBio Investigative Site 10-147
      • Santa Monica, California, United States, 90404
        • AnaptysBio Investigative Site 10-112
    • Florida
      • Doral, Florida, United States, 33122
        • AnaptysBio Investigative Site 10-136
      • Miami, Florida, United States, 33125
        • AnaptysBio Investigative Site 10-133
      • Miami, Florida, United States, 33126
        • AnaptysBio Investigative Site 10-116
      • Miami, Florida, United States, 33174
        • AnaptysBio Investigative Site 10-134
      • Miami, Florida, United States, 33179
        • AnaptysBio Investigative Site 10-106
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • AnaptysBio Investigative Site 10-122
    • Idaho
      • Boise, Idaho, United States, 83702
        • AnaptysBio Investigative Site 10-130
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • AnaptysBio Investigative Site 10-151
    • Indiana
      • Clarksville, Indiana, United States, 47129
        • AnaptysBio Investigative Site 10-127
      • Merrillville, Indiana, United States, 46410
        • AnaptysBio Investigative Site 10-149
      • New Albany, Indiana, United States, 47150
        • AnaptysBio Investigative Site 10-128
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • AnaptysBio Investigative Site 10-137
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • AnaptysBio Investigative Site 10-131
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • AnaptysBio Investigative Site 10-126
      • Auburn Hills, Michigan, United States, 48326
        • AnaptysBio Investigative Site 10-139
      • Detroit, Michigan, United States, 48202
        • AnaptysBio Investigative Site 10-114
      • Troy, Michigan, United States, 48084
        • AnaptysBio Investigative Site 10-138
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • AnaptysBio Investigative Site 10-150
      • Saint Joseph, Missouri, United States, 64506
        • AnaptysBio Investigative Site 10-110
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • AnaptysBio Investigative Site 10-148
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • AnaptysBio Investigative Site 10-109
      • Wilmington, North Carolina, United States, 28205
        • AnaptysBio Investigative Site 10-108
    • Ohio
      • Mason, Ohio, United States, 45040
        • AnaptysBio Investigative Site 10-129
    • Oregon
      • Portland, Oregon, United States, 97223
        • AnaptysBio Investigative Site 10-113
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19144
        • AnaptysBio Investigative Site 10-145
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • AnaptysBio Investigative Site 10-119
    • Texas
      • Baytown, Texas, United States, 77521
        • AnaptysBio Investigative Site 10-144
      • Dallas, Texas, United States, 75235
        • AnaptysBio Investigative Site 10-124
      • Frisco, Texas, United States, 75034
        • AnaptysBio Investigative Site 10-105
      • Katy, Texas, United States, 77494
        • AnaptysBio Investigative Site 10-142
      • San Antonio, Texas, United States, 78213
        • AnaptysBio Investigative Site 10-104
    • Washington
      • Spokane, Washington, United States, 99202
        • AnaptysBio Investigative Site 10-132

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Male or female aged 18 to 65 years and in good general health
  • Moderate to severe AD for at least 6 months prior to Randomization
  • History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable
  • EASI score ≥ 16 at Screening and at Randomization
  • vIGA AD score ≥ 3 at Screening and at Randomization
  • AD involved BSA ≥ 10% at Screening and at Randomization

Key Exclusion Criteria:

  • Any factors that in the Investigator's opinion would predispose the subject to develop an infection
  • Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status
  • Not able to tolerate SC drug administration
  • Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization

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.
Experimental: ANB032 SC Dose 1
This arm will receive treatment SC
Drug: ANB032
BTLA agonist antibody
Experimental: ANB032 SC Dose 2
This arm will receive treatment SC
Drug: ANB032
BTLA agonist antibody
Experimental: ANB032 SC Dose 3
This arm will receive treatment SC
Drug: ANB032
BTLA agonist antibody
Placebo Comparator: Placebo
This arm will receive Placebo SC
Drug: Placebo
Placebo

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
Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14
Time Frame: Baseline to Week 14
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.
Baseline to Week 14

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
Mean percent change from Baseline in EASI at Week 14
Time Frame: Baseline to Week 14
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.
Baseline to Week 14
Proportion of subjects who achieve a vIGA-AD score of 0 or 1 and ≥ 2-point reduction (improvement) from Baseline in vIGA-AD score at Week 14
Time Frame: Baseline to Week 14
Baseline to Week 14
Mean change from Baseline in EASI at Week 14
Time Frame: Baseline to Week 14
Baseline to Week 14

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: Mark Rigby, MD, AnaptysBio, Inc.

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 13, 2023

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.
October 16, 2024

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.
January 7, 2025

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).
June 6, 2023

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.
July 5, 2023

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.
July 7, 2023

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.
March 25, 2025

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.
February 12, 2025

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.
August 1, 2024

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.
  • ANB032-201

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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