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NCT05935085 Clinical Trial

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

Atopic Dermatitis Eczema Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05935085
Other study ID # ANB032-201
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 13, 2023
Est. completion date January 31, 2025

Study information
Verified date May 2024
Source AnaptysBio, Inc.
Contact Aaron Ilan
Phone 858-732-0100
Email Clinicaltrialinfo@anaptysbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date January 31, 2025
Est. primary completion date November 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ANB032
BTLA agonist antibody
• Placebo
Placebo

Locations
Country Name City State
Australia AnaptysBio Investigative Site 35-104 Coorparoo
Canada AnaptysBio Investigative Site 11-102 Barrie Ontario
Canada AnaptysBio Investigative Site 11-106 Etobicoke Ontario
Canada AnaptysBio Investigative Site 11-101 London Ontario
Canada AnaptysBio Investigative Site 11-103 North Bay Ontario
Canada AnaptysBio Investigative Site 11-107 Richmond Hill Ontario
Canada AnaptysBio Investigative Site 11-105 Surrey British Colombia
Czechia AnaptysBio Investigative Site 57-105 Prague 1
Czechia AnaptysBio Investigative Site 57-102 Prague 10
Czechia AnaptysBio Investigative Site 57-101 Prague 5
Georgia AnaptysBio Investigative Site 59-101 Tbilisi
Georgia AnaptysBio Investigative Site 59-102 Tbilisi
Georgia AnaptysBio Investigative Site 59-103 Tbilisi
Georgia AnaptysBio Investigative Site 59-104 Tbilisi
Georgia AnaptysBio Investigative Site 59-105 Tbilisi
Georgia AnaptysBio Investigative Site 59-106 Tbilisi
Georgia AnaptysBio Investigative Site 59-107 Tbilisi
New Zealand AnaptysBio Investigative Site 36-101 Grafton
New Zealand AnaptysBio Investigative Site 36-104 Nelson
New Zealand AnaptysBio Investigative Site 36-102 Rosedale
New Zealand AnaptysBio Investigative Site 36-103 Wellington
Poland AnaptysBio Investigative Site 30-111 Bydgoszcz
Poland AnaptysBio Investigative Site 30-113 Czestochowa
Poland AnaptysBio Investigative Site 30-108 Gdansk
Poland AnaptysBio Investigative Site 30-106 Kraków
Poland AnaptysBio Investigative Site 30-101 Lódz
Poland AnaptysBio Investigative Site 30-109 Rzeszów
Poland AnaptysBio Investigative Site 30-115 Skierniewice
Poland AnaptysBio Investigative Site 30-102 Swidnik
Poland AnaptysBio Investigative Site 30-112 Szczecin
Poland AnaptysBio Investigative Site 30-116 Warsaw
Poland AnaptysBio Investigative Site 30-105 Warszawa
Poland AnaptysBio Investigative Site 30-107 Warszawa
Poland AnaptysBio Investigative Site 30-104 Wroclaw
Poland AnaptysBio Investigative Site 30-114 Wroclaw
United States AnaptysBio Investigative Site 10-140 Anaheim California
United States AnaptysBio Investigative Site 10-126 Ann Arbor Michigan
United States AnaptysBio Investigative Site 10-122 Atlanta Georgia
United States AnaptysBio Investigative Site 10-139 Auburn Hills Michigan
United States AnaptysBio Investigative Site 10-137 Baton Rouge Louisiana
United States AnaptysBio Investigative Site 10-144 Baytown Texas
United States AnaptysBio Investigative Site 10-130 Boise Idaho
United States AnaptysBio Investigative Site 10-141 Cerritos California
United States AnaptysBio Investigative Site 10-109 Charlotte North Carolina
United States AnaptysBio Investigative Site 10-127 Clarksville Indiana
United States AnaptysBio Investigative Site 10-124 Dallas Texas
United States AnaptysBio Investigative Site 10-114 Detroit Michigan
United States AnaptysBio Investigative Site 10-136 Doral Florida
United States AnaptysBio Investigative Site 10-121 Fountain Valley California
United States AnaptysBio Investigative Site 10-107 Fremont California
United States AnaptysBio Investigative Site 10-105 Frisco Texas
United States AnaptysBio Investigative Site 10-150 Hazelwood Missouri
United States AnaptysBio Investigative Site 10-142 Katy Texas
United States AnaptysBio Investigative Site 10-120 Lancaster California
United States AnaptysBio Investigative Site 10-118 Las Vegas Nevada
United States AnaptysBio Investigative Site 10-148 Las Vegas Nevada
United States AnaptysBio Investigative 10-125 Lomita California
United States AnaptysBio Investigative Site 10-111 Louisville Kentucky
United States AnaptysBio Investigative Site 10-129 Mason Ohio
United States AnaptysBio Investigative Site 10-149 Merrillville Indiana
United States AnaptysBio Investigative Site 10-131 Methuen Massachusetts
United States AnaptysBio Investigative Site 10-106 Miami Florida
United States AnaptysBio Investigative Site 10-116 Miami Florida
United States AnaptysBio Investigative Site 10-133 Miami Florida
United States AnaptysBio Investigative Site 10-134 Miami Florida
United States AnaptysBio Investigative Site 10-119 Nashville Tennessee
United States AnaptysBio Investigative Site 10-128 New Albany Indiana
United States AnaptysBio Investigative Site 10-115 New York New York
United States AnaptysBio Investigative Site 10-113 Portland Oregon
United States AnaptysBio Investigative Site 10-110 Saint Joseph Missouri
United States AnaptysBio Investigative Site 10-101 San Antonio Texas
United States AnaptysBio Investigative Site 10-104 San Antonio Texas
United States AnaptysBio Investigative Site 10-112 Santa Monica California
United States AnaptysBio Investigative Site 10-132 Spokane Washington
United States AnaptysBio Investigative Site 10-138 Troy Michigan
United States AnaptysBio Investigative Site 10-108 Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Georgia,  New Zealand,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change from Baseline in EASI at 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 Mean percent change from Baseline in EASI at 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 Proportion of subjects who achieve = 75% reduction (improvement) from Baseline in EASI-75 at Week 14 Baseline to Week 14
Secondary 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
See also
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Recruiting NCT03795506 - TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE) N/A
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Completed NCT04773587 - Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis Phase 3
Active, not recruiting NCT04017520 - Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children Over Time