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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).
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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
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Secondary ID [1]
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ANB032-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis Eczema
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of subjects who achieve =75% reduction (improvement) from Baseline in EASI-75 as Week 14
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 14
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Secondary outcome [1]
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Mean percent change from Baseline in EASI at Week 14
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 14
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Secondary outcome [2]
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Mean change from Baseline in EASI at Week 14
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Assessment method [2]
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Timepoint [2]
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Baseline to Week 14
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Secondary outcome [3]
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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
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Assessment method [3]
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Timepoint [3]
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Baseline to Week 14
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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
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Minimum age
18
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/01/2025
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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AnaptysBio Investigative Site 35-103 - Woolloongabba
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Recruitment hospital [2]
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AnaptysBio Investigative Site 35-104 - Coorparoo
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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4151 - Coorparoo
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Recruitment outside Australia
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United States of America
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California
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Florida
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Swidnik
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AnaptysBio, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
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Trial website
https://clinicaltrials.gov/study/NCT05935085
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mark Rigby, MD
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Address
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AnaptysBio, Inc.
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Phone
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Email
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Contact person for public queries
Name
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Aaron Ilan
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Address
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Phone
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858-732-0100
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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