Clinical trial NCT05935085: This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects with Moderate to Severe Atopic Dermatitis (AD).
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis Eczema
Keywords: ANB032, B and T lymphocyte attenuator BTLA
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: Mean percent change from Baseline in EASI at Week 14
timeFrame: Baseline to Week 14
measure: Mean change from Baseline in EASI at Week 14
timeFrame: Baseline to Week 14
measure: 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
timeFrame: Baseline to Week 14
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: AnaptysBio Investigative Site 10-140
state: California
city: Cerritos
country: United States
facility: AnaptysBio Investigative Site 10-141
state: California
city: Fountain Valley
country: United States
facility: AnaptysBio Investigative Site 10-121
state: California
city: Fremont
country: United States
facility: AnaptysBio Investigative Site 10-107
state: California
city: Lancaster
country: United States
facility: AnaptysBio Investigative Site 10-120
state: California
city: Lomita
country: United States
facility: AnaptysBio Investigative 10-125
state: California
city: Oxnard
country: United States
facility: AnaptysBio Investigative Site 10-146
state: California
city: Pasadena
country: United States
facility: AnaptysBio Investigative Site 10-147
state: California
city: Santa Monica
country: United States
facility: AnaptysBio Investigative Site 10-112
state: California
city: Doral
country: United States
facility: AnaptysBio Investigative Site 10-136
state: Florida
city: Miami
country: United States
facility: AnaptysBio Investigative Site 10-133
state: Florida
city: Miami
country: United States
facility: AnaptysBio Investigative Site 10-116
state: Florida
city: Miami
country: United States
facility: AnaptysBio Investigative Site 10-134
state: Florida
city: Miami
country: United States
facility: AnaptysBio Investigative Site 10-106
state: Florida
city: Atlanta
country: United States
facility: AnaptysBio Investigative Site 10-122
state: Georgia
city: Boise
country: United States
facility: AnaptysBio Investigative Site 10-130
state: Idaho
city: Flossmoor
country: United States
facility: AnaptysBio Investigative Site 10-151
state: Illinois
city: Clarksville
country: United States
facility: AnaptysBio Investigative Site 10-127
state: Indiana
city: Merrillville
country: United States
facility: AnaptysBio Investigative Site 10-149
state: Indiana
city: New Albany
country: United States
facility: AnaptysBio Investigative Site 10-128
state: Indiana
city: Baton Rouge
country: United States
facility: AnaptysBio Investigative Site 10-137
state: Louisiana
city: Methuen
country: United States
facility: AnaptysBio Investigative Site 10-131
state: Massachusetts
city: Ann Arbor
country: United States
facility: AnaptysBio Investigative Site 10-126
state: Michigan
city: Auburn Hills
country: United States
facility: AnaptysBio Investigative Site 10-139
state: Michigan
city: Detroit
country: United States
facility: AnaptysBio Investigative Site 10-114
state: Michigan
city: Troy
country: United States
facility: AnaptysBio Investigative Site 10-138
state: Michigan
city: Hazelwood
country: United States
facility: AnaptysBio Investigative Site 10-150
state: Missouri
city: Saint Joseph
country: United States
facility: AnaptysBio Investigative Site 10-110
state: Missouri
city: Las Vegas
country: United States
facility: AnaptysBio Investigative Site 10-148
state: Nevada
city: Charlotte
country: United States
facility: AnaptysBio Investigative Site 10-109
state: North Carolina
city: Wilmington
country: United States
facility: AnaptysBio Investigative Site 10-108
state: North Carolina
city: Mason
country: United States
facility: AnaptysBio Investigative Site 10-129
state: Ohio
city: Portland
country: United States
facility: AnaptysBio Investigative Site 10-113
state: Oregon
city: Philadelphia
country: United States
facility: AnaptysBio Investigative Site 10-145
state: Pennsylvania
city: Nashville
country: United States
facility: AnaptysBio Investigative Site 10-119
state: Tennessee
city: Baytown
country: United States
facility: AnaptysBio Investigative Site 10-144
state: Texas
city: Dallas
country: United States
facility: AnaptysBio Investigative Site 10-124
state: Texas
city: Frisco
country: United States
facility: AnaptysBio Investigative Site 10-105
state: Texas
city: Katy
country: United States
facility: AnaptysBio Investigative Site 10-142
state: Texas
city: San Antonio
country: United States
facility: AnaptysBio Investigative Site 10-104
state: Texas
city: Spokane
country: United States
facility: AnaptysBio Investigative Site 10-132
state: Washington
city: Woolloongabba
country: Australia
facility: AnaptysBio Investigative Site 35-103
state: Queensland
city: Coorparoo
country: Australia
facility: AnaptysBio Investigative Site 35-104
city: Surrey
country: Canada
facility: AnaptysBio Investigative Site 11-105
state: British Colombia
city: Barrie
country: Canada
facility: AnaptysBio Investigative Site 11-102
state: Ontario
city: Etobicoke
country: Canada
facility: AnaptysBio Investigative Site 11-106
state: Ontario
city: London
country: Canada
facility: AnaptysBio Investigative Site 11-101
state: Ontario
city: North Bay
country: Canada
facility: AnaptysBio Investigative Site 11-103
state: Ontario
city: Richmond Hill
country: Canada
facility: AnaptysBio Investigative Site 11-107
state: Ontario
city: Pardubice
country: Czechia
facility: AnaptysBio Investigative Site 57-104
city: Prague 10
country: Czechia
facility: AnaptysBio Investigative Site 57-102
city: Prague 1
country: Czechia
facility: AnaptysBio Investigative Site 57-105
city: Prague 5
country: Czechia
facility: AnaptysBio Investigative Site 57-101
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-105
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-106
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-101
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-102
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-103
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-104
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-107
city: Grafton
country: New Zealand
facility: AnaptysBio Investigative Site 36-101
city: Nelson
country: New Zealand
facility: AnaptysBio Investigative Site 36-104
city: Rosedale
country: New Zealand
facility: AnaptysBio Investigative Site 36-102
city: Wellington
country: New Zealand
facility: AnaptysBio Investigative Site 36-103
city: Bydgoszcz
country: Poland
facility: AnaptysBio Investigative Site 30-111
city: Częstochowa
country: Poland
facility: AnaptysBio Investigative Site 30-113
city: Gdańsk
country: Poland
facility: AnaptysBio Investigative Site 30-108
city: Kraków
country: Poland
facility: AnaptysBio Investigative Site 30-106
city: Rzeszów
country: Poland
facility: AnaptysBio Investigative Site 30-109
city: Skierniewice
country: Poland
facility: AnaptysBio Investigative Site 30-115
city: Szczecin
country: Poland
facility: AnaptysBio Investigative Site 30-112
city: Warsaw
country: Poland
facility: AnaptysBio Investigative Site 30-116
city: Warszawa
country: Poland
facility: AnaptysBio Investigative Site 30-105
city: Warszawa
country: Poland
facility: AnaptysBio Investigative Site 30-107
city: Wrocław
country: Poland
facility: AnaptysBio Investigative Site 30-104
city: Wrocław
country: Poland
facility: AnaptysBio Investigative Site 30-114
city: Łódź
country: Poland
facility: AnaptysBio Investigative Site 30-101
city: Świdnik
country: Poland
facility: AnaptysBio Investigative Site 30-102
Study officials:
affiliation: AnaptysBio, Inc.
name: Mark Rigby, MD
role: STUDY_DIRECTOR
References: