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

NCT05935085 | Terminated Phase 2 FDA Drug

• 1 other identifier: ANB032-201
• Study Type: interventional
• Target: 201
• Locations: 7 countries
• Sites: 78

Brief Summary

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

Conditions

Atopic Dermatitis Eczema

Keywords

ANB032, B and T lymphocyte attenuator BTLA

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as 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 Outcomes (3)

• Mean percent change from Baseline in EASI at Week 14

  Baseline to Week 14

• Mean change from Baseline in EASI at Week 14

  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

  Baseline to Week 14

Study Arms (4)

ANB032 SC Dose 1

EXPERIMENTAL

This arm will receive treatment SC

Drug: ANB032

ANB032 SC Dose 2

EXPERIMENTAL

This arm will receive treatment SC

Drug: ANB032

ANB032 SC Dose 3

EXPERIMENTAL

This arm will receive treatment SC

Drug: ANB032

Placebo

PLACEBO COMPARATOR

This arm will receive Placebo SC

Drug: Placebo

Interventions

ANB032 DRUG

BTLA agonist antibody

ANB032 SC Dose 1; ANB032 SC Dose 2; ANB032 SC Dose 3

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AnaptysBio, Inc.: lead

Study Sites (78)

AnaptysBio Investigative Site 10-140

Anaheim, California, 92801, United States

Location

AnaptysBio Investigative Site 10-141

Cerritos, California, 90703, United States

Location

AnaptysBio Investigative Site 10-121

Fountain Valley, California, 92708, United States

Location

AnaptysBio Investigative Site 10-107

Fremont, California, 94538, United States

Location

AnaptysBio Investigative Site 10-120

Lancaster, California, 93534, United States

Location

AnaptysBio Investigative 10-125

Lomita, California, 90717, United States

Location

AnaptysBio Investigative Site 10-146

Oxnard, California, 93030, United States

Location

AnaptysBio Investigative Site 10-147

Pasadena, California, 91101, United States

Location

AnaptysBio Investigative Site 10-112

Santa Monica, California, 90404, United States

Location

AnaptysBio Investigative Site 10-136

Doral, Florida, 33122, United States

Location

AnaptysBio Investigative Site 10-133

Miami, Florida, 33125, United States

Location

AnaptysBio Investigative Site 10-116

Miami, Florida, 33126, United States

Location

AnaptysBio Investigative Site 10-134

Miami, Florida, 33174, United States

Location

AnaptysBio Investigative Site 10-106

Miami, Florida, 33179, United States

Location

AnaptysBio Investigative Site 10-122

Atlanta, Georgia, 30328, United States

Location

AnaptysBio Investigative Site 10-130

Boise, Idaho, 83702, United States

Location

AnaptysBio Investigative Site 10-151

Flossmoor, Illinois, 60422, United States

Location

AnaptysBio Investigative Site 10-127

Clarksville, Indiana, 47129, United States

Location

AnaptysBio Investigative Site 10-149

Merrillville, Indiana, 46410, United States

Location

AnaptysBio Investigative Site 10-128

New Albany, Indiana, 47150, United States

Location

AnaptysBio Investigative Site 10-137

Baton Rouge, Louisiana, 70808, United States

Location

AnaptysBio Investigative Site 10-131

Methuen, Massachusetts, 01844, United States

Location

AnaptysBio Investigative Site 10-126

Ann Arbor, Michigan, 48109, United States

Location

AnaptysBio Investigative Site 10-139

Auburn Hills, Michigan, 48326, United States

Location

AnaptysBio Investigative Site 10-114

Detroit, Michigan, 48202, United States

Location

AnaptysBio Investigative Site 10-138

Troy, Michigan, 48084, United States

Location

AnaptysBio Investigative Site 10-150

Hazelwood, Missouri, 63042, United States

Location

AnaptysBio Investigative Site 10-110

Saint Joseph, Missouri, 64506, United States

Location

AnaptysBio Investigative Site 10-148

Las Vegas, Nevada, 89121, United States

Location

AnaptysBio Investigative Site 10-109

Charlotte, North Carolina, 28277, United States

Location

AnaptysBio Investigative Site 10-108

Wilmington, North Carolina, 28205, United States

Location

AnaptysBio Investigative Site 10-129

Mason, Ohio, 45040, United States

Location

AnaptysBio Investigative Site 10-113

Portland, Oregon, 97223, United States

Location

AnaptysBio Investigative Site 10-145

Philadelphia, Pennsylvania, 19144, United States

Location

AnaptysBio Investigative Site 10-119

Nashville, Tennessee, 37215, United States

Location

AnaptysBio Investigative Site 10-144

Baytown, Texas, 77521, United States

Location

AnaptysBio Investigative Site 10-124

Dallas, Texas, 75235, United States

Location

AnaptysBio Investigative Site 10-105

Frisco, Texas, 75034, United States

Location

AnaptysBio Investigative Site 10-142

Katy, Texas, 77494, United States

Location

AnaptysBio Investigative Site 10-104

San Antonio, Texas, 78213, United States

Location

AnaptysBio Investigative Site 10-132

Spokane, Washington, 99202, United States

Location

AnaptysBio Investigative Site 35-103

Woolloongabba, Queensland, 4102, Australia

Location

AnaptysBio Investigative Site 35-104

Coorparoo, 4151, Australia

Location

AnaptysBio Investigative Site 11-105

Surrey, British Colombia, V3V 0C6, Canada

Location

AnaptysBio Investigative Site 11-102

Barrie, Ontario, L4M 7G1, Canada

Location

AnaptysBio Investigative Site 11-106

Etobicoke, Ontario, M8X 1Y9, Canada

Location

AnaptysBio Investigative Site 11-101

London, Ontario, N6H 5L5, Canada

Location

AnaptysBio Investigative Site 11-103

North Bay, Ontario, P1B327, Canada

Location

AnaptysBio Investigative Site 11-107

Richmond Hill, Ontario, L4B 1A5, Canada

Location

AnaptysBio Investigative Site 57-104

Pardubice, 53002, Czechia

Location

AnaptysBio Investigative Site 57-105

Prague, 11000, Czechia

Location

AnaptysBio Investigative Site 57-102

Prague, 13000, Czechia

Location

AnaptysBio Investigative Site 57-101

Prague, 1500, Czechia

Location

AnaptysBio Investigative Site 59-105

Tbilisi, 0112, Georgia

Location

AnaptysBio Investigative Site 59-106

Tbilisi, 0114, Georgia

Location

AnaptysBio Investigative Site 59-101

Tbilisi, 0141, Georgia

Location

AnaptysBio Investigative Site 59-102

Tbilisi, 0160, Georgia

Location

AnaptysBio Investigative Site 59-103

Tbilisi, 0160, Georgia

Location

AnaptysBio Investigative Site 59-104

Tbilisi, 0160, Georgia

Location

AnaptysBio Investigative Site 59-107

Tbilisi, 0179, Georgia

Location

AnaptysBio Investigative Site 36-101

Grafton, 1010, New Zealand

Location

AnaptysBio Investigative Site 36-104

Nelson, 7011, New Zealand

Location

AnaptysBio Investigative Site 36-102

Rosedale, 0632, New Zealand

Location

AnaptysBio Investigative Site 36-103

Wellington, 6021, New Zealand

Location

AnaptysBio Investigative Site 30-111

Bydgoszcz, 85-079, Poland

Location

AnaptysBio Investigative Site 30-113

Częstochowa, 42-217, Poland

Location

AnaptysBio Investigative Site 30-108

Gdansk, 80-214, Poland

Location

AnaptysBio Investigative Site 30-106

Krakow, 31-559, Poland

Location

AnaptysBio Investigative Site 30-101

Lodz, 90-436, Poland

Location

AnaptysBio Investigative Site 30-109

Rzeszów, 35-055, Poland

Location

AnaptysBio Investigative Site 30-115

Skierniewice, 96-100, Poland

Location

AnaptysBio Investigative Site 30-112

Szczecin, 70-332, Poland

Location

AnaptysBio Investigative Site 30-102

Świdnik, 21-040, Poland

Location

AnaptysBio Investigative Site 30-105

Warsaw, 00-874, Poland

Location

AnaptysBio Investigative Site 30-107

Warsaw, 01-817, Poland

Location

AnaptysBio Investigative Site 30-116

Warsaw, 02-677, Poland

Location

AnaptysBio Investigative Site 30-104

Wroclaw, 50-566, Poland

Location

AnaptysBio Investigative Site 30-114

Wroclaw, 51-503, Poland

Location

Study Officials

• Mark Rigby, MD

  AnaptysBio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 7, 2023
• Study Start: June 13, 2023
• Primary Completion: October 16, 2024
• Study Completion: January 7, 2025
• Last Updated: February 14, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (41); NZ (4); CA (6); AU (2); CZ (4); PL (14); GE (7)