A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT04162769
- Lead Sponsor
- Arena Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Not provided
- Presence of skin comorbidities that would interfere with study assessments of the underlying disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12-Week Double-Blind Treatment Period: Placebo Etrasimod matching placebo - 52-Week Open-Label Extension Period: Etrasimod 2 mg Etrasimod 2 mg - 12-Week Double-Blind Treatment Period: Etrasimod 2 mg Etrasimod 2 mg - 12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg) Etrasimod 1 mg -
- Primary Outcome Measures
Name Time Method Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score Baseline (Day 1) and Week 12 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.
- Secondary Outcome Measures
Name Time Method Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary Baseline (Day 1) and Week 12 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.
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 Baseline (Day 1) and Week 12 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.
Open-label Extension (OLE) Period: Percent Change in EASI Baseline (Week 16) and Week 68 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.
OLE Period: Number of Participants Achieving a EASI-75 Score Baseline (Week 16) and Week 68 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.
OLE Period: Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of ≥ 2 Points Baseline (Week 16) and Week 68 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.
OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score Baseline (Week 16) and Week 68 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.
OLE Period: Percent Change in Percent BSA Baseline (Week 16) and Week 68 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.
OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary Baseline (Week 16) and Week 28 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.
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 Baseline (Day 1) and Week 12 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.
OLE Period: Change in Patient-Oriented Eczema Measure (POEM) Baseline (Week 16) and Week 68 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.
OLE Period: Change in Dermatology Life Quality Index (DLQI) Baseline (Week 16) and Week 68 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.
OLE Period: Change in Patient Global Assessment (PGA) of Disease Baseline (Week 16) and Week 68 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.
Double-blind Treatment Period: Percentage of Participants Achieving EASI-50 Baseline (Day 1) and Week 12 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.
Double-blind Treatment Period: Percentage of Participants Achieving EASI-90 Baseline (Day 1) and Week 12 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.
Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA) Baseline (Day 1) and Week 12 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
Double-blind Treatment Period: Percentage of Participants Achieving EASI-75 Baseline (Day 1) and Week 12 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.
Trial Locations
- Locations (36)
Advanced Research Institute of Miami LLC
🇺🇸Homestead, Florida, United States
Prohealth Research Center
🇺🇸Doral, Florida, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Skin Care Research, LLC
🇺🇸Hollywood, Florida, United States
Amber Pediatrics Research, LLC
🇺🇸Miami, Florida, United States
South Miami Medical & Research Group. Inc
🇺🇸Miami, Florida, United States
Quinn Healthcare/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Diex Recherche Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Marvel Research LLC
🇺🇸Huntington Beach, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
ADVA Clinical Research, Inc
🇺🇸Inglewood, California, United States
FMC Science
🇺🇸Lampasas, Texas, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Aby's New Generation Research, Inc.
🇺🇸Hialeah, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Skin Research of South Florida
🇺🇸Miami, Florida, United States
Greenwich Village Dermatology
🇺🇸New York, New York, United States
IMA Clinical Research, LLC
🇺🇸Saint Petersburg, Florida, United States
Alliance for Multispecialty Research
🇺🇸Norfolk, Virginia, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States
Modern Research Associates, PLLC
🇺🇸Dallas, Texas, United States
TCR Medical Corporation
🇺🇸San Diego, California, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Quality Clinical Research Inc
🇺🇸Omaha, Nebraska, United States
ODRC Enterprises, LLC dba Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Skin Sciences PLLC
🇺🇸Louisville, Kentucky, United States
Amber Clinical Research, LLC
🇺🇸Miami Shores, Florida, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Premier Specialists PTY LTD
🇦🇺Kogarah, New South Wales, Australia
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia