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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
Date last updated
21/08/2024

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
Country [2] 0 0
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
State/province [5] 0 0
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
Country [27] 0 0
New Zealand
State/province [27] 0 0
Nelson
Country [28] 0 0
New Zealand
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Rosedale
Country [29] 0 0
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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Poland
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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
This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
Trial website
https://clinicaltrials.gov/study/NCT05935085
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05935085