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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

201

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

AnaptysBio, Inc.

Investigators

  • 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)

June 13, 2023

Primary Completion (Actual)

October 16, 2024

Study Completion (Actual)

January 7, 2025

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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