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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04162769




Registration number
NCT04162769
Ethics application status
Date submitted
12/11/2019
Date registered
14/11/2019

Titles & IDs
Public title
A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Scientific title
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled 16-Week Study (With a 52-Week Open-Label Extension) to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Secondary ID [1] 0 0
APD334-201
Universal Trial Number (UTN)
Trial acronym
ADVISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 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 - Etrasimod 1 mg
Treatment: Drugs - Etrasimod 2 mg
Treatment: Drugs - Etrasimod matching placebo

Experimental: 12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg) -

Experimental: 12-Week Double-Blind Treatment Period: Etrasimod 2 mg -

Placebo comparator: 12-Week Double-Blind Treatment Period: Placebo -

Experimental: 52-Week Open-Label Extension Period: Etrasimod 2 mg -


Treatment: Drugs: Etrasimod 1 mg
Etrasimod 1 mg tablet taken by mouth, once daily

Treatment: Drugs: Etrasimod 2 mg
Etrasimod 2 mg tablet taken by mouth, once daily.

Treatment: Drugs: Etrasimod matching placebo
Etrasimod matching placebo tablet by mouth, once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score
Timepoint [1] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [1] 0 0
Double-blind Treatment Period: Percentage of Participants Achieving EASI-75
Timepoint [1] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [2] 0 0
Double-blind Treatment Period: Percentage of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of >= 2 Points
Timepoint [2] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [3] 0 0
Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary
Timepoint [3] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [4] 0 0
Double-blind Treatment Period: Percentage of Participants With Improvement (Reduction) in Peak Pruritus NRS Greater Than or Equal to (>=)3 From an Itch Daily Diary
Timepoint [4] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [5] 0 0
Double-blind Treatment Period: Percentage of Participants Achieving EASI-50
Timepoint [5] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [6] 0 0
Double-blind Treatment Period: Percentage of Participants Achieving EASI-90
Timepoint [6] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [7] 0 0
Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA)
Timepoint [7] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [8] 0 0
Open-label Extension (OLE) Period: Percent Change in EASI
Timepoint [8] 0 0
Baseline (Week 16) and Week 68
Secondary outcome [9] 0 0
OLE Period: Number of Participants Achieving a EASI-75 Score
Timepoint [9] 0 0
Baseline (Week 16) and Week 68
Secondary outcome [10] 0 0
OLE Period: Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of = 2 Points
Timepoint [10] 0 0
Baseline (Week 16) and Week 68
Secondary outcome [11] 0 0
OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score
Timepoint [11] 0 0
Baseline (Week 16) and Week 68
Secondary outcome [12] 0 0
OLE Period: Percent Change in Percent BSA
Timepoint [12] 0 0
Baseline (Week 16) and Week 68
Secondary outcome [13] 0 0
OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary
Timepoint [13] 0 0
Baseline (Week 16) and Week 28
Secondary outcome [14] 0 0
OLE Period: Change in Patient-Oriented Eczema Measure (POEM)
Timepoint [14] 0 0
Baseline (Week 16) and Week 68
Secondary outcome [15] 0 0
OLE Period: Change in Dermatology Life Quality Index (DLQI)
Timepoint [15] 0 0
Baseline (Week 16) and Week 68
Secondary outcome [16] 0 0
OLE Period: Change in Patient Global Assessment (PGA) of Disease
Timepoint [16] 0 0
Baseline (Week 16) and Week 68

Eligibility
Key inclusion criteria
Inclusion criteria:

* Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria, that has been present for at least 1 year prior to the Screening Visit
* Participants with Eczema Area and Severity Index (EASI) = 12 at the Screening Visit and = 16 at the Baseline Visit
* Participants with validated Investigator's Global Assessment (vIGA) score = 3 (on the 0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening and Baseline visits
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of skin comorbidities that would interfere with study assessments of the underlying disease.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/10/2021
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Premier Specialists PTY LTD - Kogarah
Recruitment hospital [2] 0 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
South Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arena Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Arena CT.gov Administrator
Address 0 0
Arena Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04162769