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

NCT ID: NCT05935085

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-13

Study Completion Date

2025-01-07

Brief Summary

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

Detailed Description

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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).

Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ANB032 SC Dose 1

This arm will receive treatment SC

Group Type EXPERIMENTAL

ANB032

Intervention Type DRUG

BTLA agonist antibody

ANB032 SC Dose 2

This arm will receive treatment SC

Group Type EXPERIMENTAL

ANB032

Intervention Type DRUG

BTLA agonist antibody

ANB032 SC Dose 3

This arm will receive treatment SC

Group Type EXPERIMENTAL

ANB032

Intervention Type DRUG

BTLA agonist antibody

Placebo

This arm will receive Placebo SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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ANB032

BTLA agonist antibody

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AnaptysBio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Rigby, MD

Role: STUDY_DIRECTOR

AnaptysBio, Inc.

Locations

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AnaptysBio Investigative Site 10-140

Anaheim, California, United States

Site Status

AnaptysBio Investigative Site 10-141

Cerritos, California, United States

Site Status

AnaptysBio Investigative Site 10-121

Fountain Valley, California, United States

Site Status

AnaptysBio Investigative Site 10-107

Fremont, California, United States

Site Status

AnaptysBio Investigative Site 10-120

Lancaster, California, United States

Site Status

AnaptysBio Investigative 10-125

Lomita, California, United States

Site Status

AnaptysBio Investigative Site 10-146

Oxnard, California, United States

Site Status

AnaptysBio Investigative Site 10-147

Pasadena, California, United States

Site Status

AnaptysBio Investigative Site 10-112

Santa Monica, California, United States

Site Status

AnaptysBio Investigative Site 10-136

Doral, Florida, United States

Site Status

AnaptysBio Investigative Site 10-133

Miami, Florida, United States

Site Status

AnaptysBio Investigative Site 10-116

Miami, Florida, United States

Site Status

AnaptysBio Investigative Site 10-134

Miami, Florida, United States

Site Status

AnaptysBio Investigative Site 10-106

Miami, Florida, United States

Site Status

AnaptysBio Investigative Site 10-122

Atlanta, Georgia, United States

Site Status

AnaptysBio Investigative Site 10-130

Boise, Idaho, United States

Site Status

AnaptysBio Investigative Site 10-151

Flossmoor, Illinois, United States

Site Status

AnaptysBio Investigative Site 10-127

Clarksville, Indiana, United States

Site Status

AnaptysBio Investigative Site 10-149

Merrillville, Indiana, United States

Site Status

AnaptysBio Investigative Site 10-128

New Albany, Indiana, United States

Site Status

AnaptysBio Investigative Site 10-137

Baton Rouge, Louisiana, United States

Site Status

AnaptysBio Investigative Site 10-131

Methuen, Massachusetts, United States

Site Status

AnaptysBio Investigative Site 10-126

Ann Arbor, Michigan, United States

Site Status

AnaptysBio Investigative Site 10-139

Auburn Hills, Michigan, United States

Site Status

AnaptysBio Investigative Site 10-114

Detroit, Michigan, United States

Site Status

AnaptysBio Investigative Site 10-138

Troy, Michigan, United States

Site Status

AnaptysBio Investigative Site 10-150

Hazelwood, Missouri, United States

Site Status

AnaptysBio Investigative Site 10-110

Saint Joseph, Missouri, United States

Site Status

AnaptysBio Investigative Site 10-148

Las Vegas, Nevada, United States

Site Status

AnaptysBio Investigative Site 10-109

Charlotte, North Carolina, United States

Site Status

AnaptysBio Investigative Site 10-108

Wilmington, North Carolina, United States

Site Status

AnaptysBio Investigative Site 10-129

Mason, Ohio, United States

Site Status

AnaptysBio Investigative Site 10-113

Portland, Oregon, United States

Site Status

AnaptysBio Investigative Site 10-145

Philadelphia, Pennsylvania, United States

Site Status

AnaptysBio Investigative Site 10-119

Nashville, Tennessee, United States

Site Status

AnaptysBio Investigative Site 10-144

Baytown, Texas, United States

Site Status

AnaptysBio Investigative Site 10-124

Dallas, Texas, United States

Site Status

AnaptysBio Investigative Site 10-105

Frisco, Texas, United States

Site Status

AnaptysBio Investigative Site 10-142

Katy, Texas, United States

Site Status

AnaptysBio Investigative Site 10-104

San Antonio, Texas, United States

Site Status

AnaptysBio Investigative Site 10-132

Spokane, Washington, United States

Site Status

AnaptysBio Investigative Site 35-103

Woolloongabba, Queensland, Australia

Site Status

AnaptysBio Investigative Site 35-104

Coorparoo, , Australia

Site Status

AnaptysBio Investigative Site 11-105

Surrey, British Colombia, Canada

Site Status

AnaptysBio Investigative Site 11-102

Barrie, Ontario, Canada

Site Status

AnaptysBio Investigative Site 11-106

Etobicoke, Ontario, Canada

Site Status

AnaptysBio Investigative Site 11-101

London, Ontario, Canada

Site Status

AnaptysBio Investigative Site 11-103

North Bay, Ontario, Canada

Site Status

AnaptysBio Investigative Site 11-107

Richmond Hill, Ontario, Canada

Site Status

AnaptysBio Investigative Site 57-104

Pardubice, , Czechia

Site Status

AnaptysBio Investigative Site 57-105

Prague, , Czechia

Site Status

AnaptysBio Investigative Site 57-102

Prague, , Czechia

Site Status

AnaptysBio Investigative Site 57-101

Prague, , Czechia

Site Status

AnaptysBio Investigative Site 59-105

Tbilisi, , Georgia

Site Status

AnaptysBio Investigative Site 59-106

Tbilisi, , Georgia

Site Status

AnaptysBio Investigative Site 59-101

Tbilisi, , Georgia

Site Status

AnaptysBio Investigative Site 59-102

Tbilisi, , Georgia

Site Status

AnaptysBio Investigative Site 59-103

Tbilisi, , Georgia

Site Status

AnaptysBio Investigative Site 59-104

Tbilisi, , Georgia

Site Status

AnaptysBio Investigative Site 59-107

Tbilisi, , Georgia

Site Status

AnaptysBio Investigative Site 36-101

Grafton, , New Zealand

Site Status

AnaptysBio Investigative Site 36-104

Nelson, , New Zealand

Site Status

AnaptysBio Investigative Site 36-102

Rosedale, , New Zealand

Site Status

AnaptysBio Investigative Site 36-103

Wellington, , New Zealand

Site Status

AnaptysBio Investigative Site 30-111

Bydgoszcz, , Poland

Site Status

AnaptysBio Investigative Site 30-113

Częstochowa, , Poland

Site Status

AnaptysBio Investigative Site 30-108

Gdansk, , Poland

Site Status

AnaptysBio Investigative Site 30-106

Krakow, , Poland

Site Status

AnaptysBio Investigative Site 30-101

Lodz, , Poland

Site Status

AnaptysBio Investigative Site 30-109

Rzeszów, , Poland

Site Status

AnaptysBio Investigative Site 30-115

Skierniewice, , Poland

Site Status

AnaptysBio Investigative Site 30-112

Szczecin, , Poland

Site Status

AnaptysBio Investigative Site 30-102

Świdnik, , Poland

Site Status

AnaptysBio Investigative Site 30-105

Warsaw, , Poland

Site Status

AnaptysBio Investigative Site 30-107

Warsaw, , Poland

Site Status

AnaptysBio Investigative Site 30-116

Warsaw, , Poland

Site Status

AnaptysBio Investigative Site 30-104

Wroclaw, , Poland

Site Status

AnaptysBio Investigative Site 30-114

Wroclaw, , Poland

Site Status

Countries

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United States Australia Canada Czechia Georgia New Zealand Poland

Other Identifiers

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ANB032-201

Identifier Type: -

Identifier Source: org_study_id

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