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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05935085




Registration number
NCT05935085
Ethics application status
Date submitted
6/06/2023
Date registered
7/07/2023

Titles & IDs
Public title
This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).
Scientific 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
Secondary ID [1] 0 0
ANB032-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis Eczema 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ANB032
Treatment: Drugs - Placebo

Experimental: ANB032 SC Dose 1 - This arm will receive treatment SC

Experimental: ANB032 SC Dose 2 - This arm will receive treatment SC

Experimental: ANB032 SC Dose 3 - This arm will receive treatment SC

Placebo comparator: Placebo - This arm will receive Placebo SC


Treatment: Drugs: ANB032
BTLA agonist antibody

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects who achieve =75% reduction (improvement) from Baseline in EASI-75 as Week 14
Timepoint [1] 0 0
Baseline to Week 14
Secondary outcome [1] 0 0
Mean percent change from Baseline in EASI at Week 14
Timepoint [1] 0 0
Baseline to Week 14
Secondary outcome [2] 0 0
Mean change from Baseline in EASI at Week 14
Timepoint [2] 0 0
Baseline to Week 14
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline to Week 14

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
AnaptysBio Investigative Site 35-103 - Woolloongabba
Recruitment hospital [2] 0 0
AnaptysBio Investigative Site 35-104 - Coorparoo
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
4151 - Coorparoo
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
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United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
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Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Canada
State/province [19] 0 0
British Colombia
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Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Czechia
State/province [21] 0 0
Pardubice
Country [22] 0 0
Czechia
State/province [22] 0 0
Prague 10
Country [23] 0 0
Czechia
State/province [23] 0 0
Prague 1
Country [24] 0 0
Czechia
State/province [24] 0 0
Prague 5
Country [25] 0 0
Georgia
State/province [25] 0 0
Tbilisi
Country [26] 0 0
New Zealand
State/province [26] 0 0
Grafton
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New Zealand
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Nelson
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New Zealand
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Rosedale
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New Zealand
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Wellington
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Poland
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Bydgoszcz
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Poland
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Czestochowa
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Poland
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Gdansk
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Poland
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Kraków
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Poland
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Rzeszów
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Poland
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Skierniewice
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Poland
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Szczecin
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Poland
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Warsaw
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Warszawa
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Poland
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Wroclaw
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Poland
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Lódz
Country [41] 0 0
Poland
State/province [41] 0 0
Swidnik

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AnaptysBio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Rigby, MD
Address 0 0
AnaptysBio, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Aaron Ilan
Address 0 0
Country 0 0
Phone 0 0
858-732-0100
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05935085