Atopic Dermatitis EczemaPhase 2NCT05935085

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

A Phase 2 study testing ANB032 in people with Atopic Dermatitis Eczema, run by AnaptysBio, Inc. at 78 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Dermatitis Eczema
What is being tested?: ANB032
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 201 participants
Where: 78 sitesin 7 countries
Study dates: 13 Jun 2023to 7 Jan 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

78 sites in 7 countries.

Country

City, postcode or hospital

78 sites in 7 countries

United States41 sites

AnaptysBio Investigative Site 10-140
Anaheim, California, 92801
AnaptysBio Investigative Site 10-126
Ann Arbor, Michigan, 48109
AnaptysBio Investigative Site 10-122
Atlanta, Georgia, 30328
AnaptysBio Investigative Site 10-139
Auburn Hills, Michigan, 48326
AnaptysBio Investigative Site 10-137
Baton Rouge, Louisiana, 70808
AnaptysBio Investigative Site 10-144
Baytown, Texas, 77521
AnaptysBio Investigative Site 10-130
Boise, Idaho, 83702
AnaptysBio Investigative Site 10-141
Cerritos, California, 90703
AnaptysBio Investigative Site 10-109
Charlotte, North Carolina, 28277
AnaptysBio Investigative Site 10-127
Clarksville, Indiana, 47129
AnaptysBio Investigative Site 10-124
Dallas, Texas, 75235
AnaptysBio Investigative Site 10-114
Detroit, Michigan, 48202
AnaptysBio Investigative Site 10-136
Doral, Florida, 33122
AnaptysBio Investigative Site 10-151
Flossmoor, Illinois, 60422
AnaptysBio Investigative Site 10-121
Fountain Valley, California, 92708
AnaptysBio Investigative Site 10-107
Fremont, California, 94538
AnaptysBio Investigative Site 10-105
Frisco, Texas, 75034
AnaptysBio Investigative Site 10-150
Hazelwood, Missouri, 63042
AnaptysBio Investigative Site 10-142
Katy, Texas, 77494
AnaptysBio Investigative Site 10-120
Lancaster, California, 93534
AnaptysBio Investigative Site 10-148
Las Vegas, Nevada, 89121
AnaptysBio Investigative 10-125
Lomita, California, 90717
AnaptysBio Investigative Site 10-129
Mason, Ohio, 45040
AnaptysBio Investigative Site 10-149
Merrillville, Indiana, 46410
AnaptysBio Investigative Site 10-131
Methuen, Massachusetts, 01844
AnaptysBio Investigative Site 10-133
Miami, Florida, 33125
AnaptysBio Investigative Site 10-116
Miami, Florida, 33126
AnaptysBio Investigative Site 10-134
Miami, Florida, 33174
AnaptysBio Investigative Site 10-106
Miami, Florida, 33179
AnaptysBio Investigative Site 10-119
Nashville, Tennessee, 37215
AnaptysBio Investigative Site 10-128
New Albany, Indiana, 47150
AnaptysBio Investigative Site 10-146
Oxnard, California, 93030
AnaptysBio Investigative Site 10-147
Pasadena, California, 91101
AnaptysBio Investigative Site 10-145
Philadelphia, Pennsylvania, 19144
AnaptysBio Investigative Site 10-113
Portland, Oregon, 97223
AnaptysBio Investigative Site 10-110
Saint Joseph, Missouri, 64506
AnaptysBio Investigative Site 10-104
San Antonio, Texas, 78213
AnaptysBio Investigative Site 10-112
Santa Monica, California, 90404
AnaptysBio Investigative Site 10-132
Spokane, Washington, 99202
AnaptysBio Investigative Site 10-138
Troy, Michigan, 48084
AnaptysBio Investigative Site 10-108
Wilmington, North Carolina, 28205

Other trials in United States

Poland14 sites

AnaptysBio Investigative Site 30-111
Bydgoszcz, 85-079
AnaptysBio Investigative Site 30-113
Częstochowa, 42-217
AnaptysBio Investigative Site 30-108
Gdansk, 80-214
AnaptysBio Investigative Site 30-106
Krakow, 31-559
AnaptysBio Investigative Site 30-101
Lodz, 90-436
AnaptysBio Investigative Site 30-109
Rzeszów, 35-055
AnaptysBio Investigative Site 30-115
Skierniewice, 96-100
AnaptysBio Investigative Site 30-102
Świdnik, 21-040
AnaptysBio Investigative Site 30-112
Szczecin, 70-332
AnaptysBio Investigative Site 30-105
Warsaw, 00-874
AnaptysBio Investigative Site 30-107
Warsaw, 01-817
AnaptysBio Investigative Site 30-116
Warsaw, 02-677
AnaptysBio Investigative Site 30-104
Wroclaw, 50-566
AnaptysBio Investigative Site 30-114
Wroclaw, 51-503

Other trials in Poland

Georgia7 sites

AnaptysBio Investigative Site 59-105
Tbilisi, 0112
AnaptysBio Investigative Site 59-106
Tbilisi, 0114
AnaptysBio Investigative Site 59-101
Tbilisi, 0141
AnaptysBio Investigative Site 59-102
Tbilisi, 0160
AnaptysBio Investigative Site 59-103
Tbilisi, 0160
AnaptysBio Investigative Site 59-104
Tbilisi, 0160
AnaptysBio Investigative Site 59-107
Tbilisi, 0179

Other trials in Georgia

Canada6 sites

AnaptysBio Investigative Site 11-102
Barrie, Ontario, L4M 7G1
AnaptysBio Investigative Site 11-106
Etobicoke, Ontario, M8X 1Y9
AnaptysBio Investigative Site 11-101
London, Ontario, N6H 5L5
AnaptysBio Investigative Site 11-103
North Bay, Ontario, P1B327
AnaptysBio Investigative Site 11-107
Richmond Hill, Ontario, L4B 1A5
AnaptysBio Investigative Site 11-105
Surrey, British Colombia, V3V 0C6

Other trials in Canada

Czechia4 sites

AnaptysBio Investigative Site 57-104
Pardubice, 53002
AnaptysBio Investigative Site 57-105
Prague, 11000
AnaptysBio Investigative Site 57-102
Prague, 13000
AnaptysBio Investigative Site 57-101
Prague, 1500

Other trials in Czechia

New Zealand4 sites

AnaptysBio Investigative Site 36-101
Grafton, 1010
AnaptysBio Investigative Site 36-104
Nelson, 7011
AnaptysBio Investigative Site 36-102
Rosedale, 0632
AnaptysBio Investigative Site 36-103
Wellington, 6021

Other trials in New Zealand

Australia2 sites

AnaptysBio Investigative Site 35-104
Coorparoo, 4151
AnaptysBio Investigative Site 35-103
Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

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

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

Read the 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).

Conditions: Atopic Dermatitis Eczema
Being tested: ANB032, Placebo
Keywords: ANB032, B and T lymphocyte attenuator BTLA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ANB032Drug
BTLA agonist antibody
PlaceboDrug
Placebo

Study groups in NCT05935085
Study group	Role	What they receive
ANB032 SC Dose 1	Experimental	This arm will receive treatment SC Receives: Drug: ANB032
ANB032 SC Dose 2	Experimental	This arm will receive treatment SC Receives: Drug: ANB032
ANB032 SC Dose 3	Experimental	This arm will receive treatment SC Receives: Drug: ANB032
Placebo	Placebo comparator	This arm will receive Placebo SC Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to Week 14

Secondary outcomes (3)

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.
Measured: Baseline to Week 14
Mean change from Baseline in EASI at Week 14
Measured: 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
Measured: Baseline to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 20237 Jan 2025

First posted7 Jul 2023
Study start13 Jun 2023
Primary completion16 Oct 2024
Study completion7 Jan 2025

Why it stopped: ANB032 did not meet the primary endpoint in moderate-to-severe atopic dermatitis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05935085
Sponsor's protocol ID: ANB032-201
Status last verified: Aug 2024
First submitted: 6 Jun 2023
Last updated: 14 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Metabolic Profiling of Immune Responses in Immune-mediated Diseases
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Studies of Skin Microbes in Healthy People and in People With Skin Conditions
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A Study to Investigate Dupixent/ Dupilumab in Adult Indian Participants With Moderate-to-severe Atopic Dermatitis
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Active, not recruitingPhase 4
DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
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RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
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All Atopic Dermatitis Eczema trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05935085
Acronym / sponsor ID: ANB032-201
Conditions: Atopic Dermatitis Eczema
Keywords: ANB032, B and T lymphocyte attenuator BTLA
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: ANB032 did not meet the primary endpoint in moderate-to-severe atopic dermatitis
Enrolment: 201 participants (actual)
Lead sponsor: AnaptysBio, Inc.Industry (pharma, biotech, devices)
Study start: 13 Jun 2023 (actual)
Primary completion: 16 Oct 2024 (actual)
Study completion: 7 Jan 2025 (actual)
First posted: 7 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
ANB032 SC Dose 1	Experimental	Drug: ANB032This arm will receive treatment SC
ANB032 SC Dose 2	Experimental	Drug: ANB032This arm will receive treatment SC
ANB032 SC Dose 3	Experimental	Drug: ANB032This arm will receive treatment SC
Placebo	Placebo comparator	Drug: PlaceboThis arm will receive Placebo SC

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ANB032BTLA agonist antibody	Drug	ANB032 SC Dose 1, ANB032 SC Dose 2, ANB032 SC Dose 3
PlaceboPlacebo	Drug	Placebo

Primary outcome

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.

3 secondary outcomes

Mean percent change from Baseline in EASI at Week 14
Time frame: Baseline to Week 14
Mean change from Baseline in EASI at Week 14
Time frame: 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

Results and safety

The study was stopped early (reason given: ANB032 did not meet the primary endpoint in moderate-to-severe atopic dermatitis). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis Eczema

RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
Not yet recruitingPhase 4
A Study to Investigate Dupixent/ Dupilumab in Adult Indian Participants With Moderate-to-severe Atopic Dermatitis
Atopic Dermatitis
Active, not recruitingPhase 4
DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Atopic Dermatitis, Atopic Dermatitis Eczema
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Rigby, MD study director

AnaptysBio, Inc.

78 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ANB032 in people with Atopic Dermatitis Eczema, run by AnaptysBio, Inc. at 78 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Poland, Georgia, Canada, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: ANB032 did not meet the primary endpoint in moderate-to-severe atopic dermatitis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14 (time frame: Baseline to Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05935085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.