Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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
Query!
Secondary ID [1]
0
0
APD334-201
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ADVISE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score
Query!
Assessment method [1]
0
0
EASI evaluates severity of participant's AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. Baseline is defined as Day 1 pre-randomization assessments.
Query!
Timepoint [1]
0
0
Baseline (Day 1) and Week 12
Query!
Secondary outcome [1]
0
0
Double-blind Treatment Period: Percentage of Participants Achieving EASI-75
Query!
Assessment method [1]
0
0
EASI-75 is defined as a 75% reduction or greater in EASI score from Baseline to Week 12. Baseline is defined as Day 1 pre-randomization assessments.
Query!
Timepoint [1]
0
0
Baseline (Day 1) and Week 12
Query!
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
Query!
Assessment method [2]
0
0
The vIGA scale for AD is a 5-point scale to measure disease severity. The vIGA score was selected using descriptors that best described the overall appearance of skin lesions at a given time point using the following scoring: 0 = clear (no inflammatory signs of AD); 1 = almost clear (barely perceptible erythema and papulation); 2 = mild (slight but definite erythema and papulation); 3 = moderate (clearly perceptible erythema and papulation); and 4 = severe (marked erythema and papulation); Higher score indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments.
Query!
Timepoint [2]
0
0
Baseline (Day 1) and Week 12
Query!
Secondary outcome [3]
0
0
Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary
Query!
Assessment method [3]
0
0
Pruritus NRS is an assessment tool that was used to report the intensity of a participant's pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments.
Query!
Timepoint [3]
0
0
Baseline (Day 1) and Week 12
Query!
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
Query!
Assessment method [4]
0
0
Pruritus NRS is an assessment tool that was used to report the intensity of a participant's pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Percentage of participants with improvement (reduction) in peak pruritus NRS \>=3 from an itch daily diary is presented. Baseline is defined as Day 1 pre-randomization assessments.
Query!
Timepoint [4]
0
0
Baseline (Day 1) and Week 12
Query!
Secondary outcome [5]
0
0
Double-blind Treatment Period: Percentage of Participants Achieving EASI-50
Query!
Assessment method [5]
0
0
EASI-50 is defined as a 50% reduction or greater of EASI from Baseline to Week 12. Percentage of participants achieving EASI-50 is presented. Baseline is defined as Day 1 pre-randomization assessments.
Query!
Timepoint [5]
0
0
Baseline (Day 1) and Week 12
Query!
Secondary outcome [6]
0
0
Double-blind Treatment Period: Percentage of Participants Achieving EASI-90
Query!
Assessment method [6]
0
0
EASI-90 is defined as as a 90% reduction or greater of EASI from Baseline to Week 12. Percentage of participants achieving EASI-90 is presented Baseline is defined as Day 1 pre-randomization assessments.
Query!
Timepoint [6]
0
0
Baseline (Day 1) and Week 12
Query!
Secondary outcome [7]
0
0
Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA)
Query!
Assessment method [7]
0
0
BSA affected by AD were assessed for each section of the body. The possible highest score for each region was: head and neck (9%), anterior trunk (18%), back (18%), upper limbs (18%), lower limbs (36%), and genitals (1%) and were reported as a percentage of all major body sections combined; higher % BSA indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments
Query!
Timepoint [7]
0
0
Baseline (Day 1) and Week 12
Query!
Secondary outcome [8]
0
0
Open-label Extension (OLE) Period: Percent Change in EASI
Query!
Assessment method [8]
0
0
EASI evaluates severity of participant's AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.
Query!
Timepoint [8]
0
0
Baseline (Week 16) and Week 68
Query!
Secondary outcome [9]
0
0
OLE Period: Number of Participants Achieving a EASI-75 Score
Query!
Assessment method [9]
0
0
EASI evaluates severity of participant's AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. EASI-75 is defined as a \>=75% reduction or greater of EASI from Baseline.
Query!
Timepoint [9]
0
0
Baseline (Week 16) and Week 68
Query!
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
Query!
Assessment method [10]
0
0
The vIGA scale for AD is a 5-point scale to measure disease severity. The vIGA score was selected using descriptors that best described the overall appearance of skin lesions at a given time point using the following scoring: 0 = clear (no inflammatory signs of AD); 1 = almost clear (barely perceptible erythema and papulation); 2 = mild (slight but definite erythema and papulation); 3 = moderate (clearly perceptible erythema and papulation); and 4 = severe (marked erythema and papulation); Higher score indicated greater severity.
Query!
Timepoint [10]
0
0
Baseline (Week 16) and Week 68
Query!
Secondary outcome [11]
0
0
OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score
Query!
Assessment method [11]
0
0
The SCORAD is a validated measure of the extent and severity of AD using 3 components: A = extent or affected BSA, B = severity and C = subjective symptoms. The extent of AD was assessed as percentage of each defined body area and reported as the sum of all areas, with a maximum score of 100%. The severity of 6 specific symptoms was assessed using the following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points, assigned as "B" in the overall SCORAD calculation). Subjective assessment of itch and sleeplessness was recorded for each symptom by the participant or relative on a Visual Analogue Scale, where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum possible score of 20. This parameter is assigned as "C" in the overall SCORAD calculation. The total SCORAD ranged from 0 (no disease) to 103 (severe disease); higher score indicated more severe AD.
Query!
Timepoint [11]
0
0
Baseline (Week 16) and Week 68
Query!
Secondary outcome [12]
0
0
OLE Period: Percent Change in Percent BSA
Query!
Assessment method [12]
0
0
BSA affected by AD were assessed for each section of the body. The possible highest score for each region was: head and neck (9%), anterior trunk (18%), back (18%), upper limbs (18%), lower limbs (36%), and genitals (1%) and were reported as a percentage of all major body sections combined; higher % BSA indicated greater severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.
Query!
Timepoint [12]
0
0
Baseline (Week 16) and Week 68
Query!
Secondary outcome [13]
0
0
OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary
Query!
Assessment method [13]
0
0
Pruritus NRS is an assessment tool that was used to report the intensity of a participant's pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.
Query!
Timepoint [13]
0
0
Baseline (Week 16) and Week 28
Query!
Secondary outcome [14]
0
0
OLE Period: Change in Patient-Oriented Eczema Measure (POEM)
Query!
Assessment method [14]
0
0
The POEM is a participant-derived validated tool used for monitoring atopic eczema severity. The POEM consisted of 7 questions asking participants to rank how many days over the past 7 days they had experienced specific AD-related symptoms. Each of the 7 questions carried equal weight and was scored from 0 to 4 as follows: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; Every day = 4. The scores from the 7 questions were added up to give an overall POEM score as: 0-2 = 'clear/almost clear', 3-7 = 'mild', 8-16 = 'moderate', 17-24 = 'severe', and 25-28 = 'very severe atopic eczema'; higher scores indicated worse atopic eczema severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.
Query!
Timepoint [14]
0
0
Baseline (Week 16) and Week 68
Query!
Secondary outcome [15]
0
0
OLE Period: Change in Dermatology Life Quality Index (DLQI)
Query!
Assessment method [15]
0
0
The DLQI is a validated 10-item questionnaire designed to measure the impact of skin disease on the Quality of Life (QoL). DLQI is a response to 10 items, which assessed QoL over the past week. For each item, the scale was rated as follows: 0 = "not at all"; 1 = "a little"; 2 = "a lot"; 3 = "very much," with an overall scoring system of 0 to 30; higher scores indicated a poor QoL. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.
Query!
Timepoint [15]
0
0
Baseline (Week 16) and Week 68
Query!
Secondary outcome [16]
0
0
OLE Period: Change in Patient Global Assessment (PGA) of Disease
Query!
Assessment method [16]
0
0
PGA is an assessment tool that was used by participant to rate the disease and disease severity. Participants rated their overall well-being based on a 5-point Likert scale from poor to excellent. Response choices were: 1- 'Poor', 2- 'Fair', 3- 'Good', 4- 'Very Good,' or 5- 'Excellent'; higher scores indicated better well-being. For the 5-point Likert scale, a positive change from baseline indicates an improvement. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.
Query!
Timepoint [16]
0
0
Baseline (Week 16) and Week 68
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Presence of skin comorbidities that would interfere with study assessments of the underlying disease.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/10/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
11/10/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
140
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Premier Specialists PTY LTD - Kogarah
Query!
Recruitment hospital [2]
0
0
Sinclair Dermatology - East Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
3002 - East Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Mississippi
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nebraska
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Nevada
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oregon
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
South Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
South Dakota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Virginia
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Washington
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Quebec
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Arena Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).
Query!
Trial website
https://clinicaltrials.gov/study/NCT04162769
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Arena CT.gov Administrator
Query!
Address
0
0
Arena Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/69/NCT04162769/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/69/NCT04162769/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04162769