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The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg) | Experimental |
| |
| 12-Week Double-Blind Treatment Period: Etrasimod 2 mg | Experimental |
| |
| 12-Week Double-Blind Treatment Period: Placebo | Placebo Comparator |
| |
| 52-Week Open-Label Extension Period: Etrasimod 2 mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod 1 mg | Drug | Etrasimod 1 mg tablet taken by mouth, once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score | 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. | Baseline (Day 1) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind Treatment Period: Percentage of Participants Achieving EASI-75 | 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. | Baseline (Day 1) and Week 12 |
| 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 |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noble Clinical Research | Tucson | Arizona | 85704 | United States | ||
| Hope Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39575597 | Derived | Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173. |
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A total of 140 participants were randomized into the 12-week Double-Blind Treatment Period and a total of 95 participants continued into the 52-Week OLE Period.
This was a 2-treatment period study (12-Week Double-Blind Treatment Period and 52-Week Open-label extension [OLE] Period), to evaluate the safety and efficacy of etrasimod monotherapy compared with placebo in participants with moderate-to-severe atopic dermatitis (AD), whose disease was not adequately controlled with topical therapies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind Treatment Period: Etrasimod 1 Milligrams (mg) | Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment (12-Week) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 19, 2019 | Aug 24, 2022 |
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| Etrasimod 2 mg | Drug | Etrasimod 2 mg tablet taken by mouth, once daily. |
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| Etrasimod matching placebo | Drug | Etrasimod matching placebo tablet by mouth, once daily. |
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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. |
| Baseline (Day 1) and Week 12 |
| Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary | 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. | Baseline (Day 1) and Week 12 |
| 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 | 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. | Baseline (Day 1) and Week 12 |
| Double-blind Treatment Period: Percentage of Participants Achieving EASI-50 | 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. | Baseline (Day 1) and Week 12 |
| Double-blind Treatment Period: Percentage of Participants Achieving EASI-90 | 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. | Baseline (Day 1) and Week 12 |
| Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA) | 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 | Baseline (Day 1) and Week 12 |
| Open-label Extension (OLE) Period: Percent Change in EASI | 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. | Baseline (Week 16) and Week 68 |
| OLE Period: Number of Participants Achieving a EASI-75 Score | 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. | Baseline (Week 16) and Week 68 |
| OLE Period: Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of ≥ 2 Points | 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 (Week 16) and Week 68 |
| OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score | 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. | Baseline (Week 16) and Week 68 |
| OLE Period: Percent Change in Percent BSA | 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. | Baseline (Week 16) and Week 68 |
| OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary | 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. | Baseline (Week 16) and Week 28 |
| OLE Period: Change in Patient-Oriented Eczema Measure (POEM) | 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. | Baseline (Week 16) and Week 68 |
| OLE Period: Change in Dermatology Life Quality Index (DLQI) | 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. | Baseline (Week 16) and Week 68 |
| OLE Period: Change in Patient Global Assessment (PGA) of Disease | 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. | Baseline (Week 16) and Week 68 |
| Canoga Park |
| California |
| 91303 |
| United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Marvel Research LLC | Huntington Beach | California | 92647 | United States |
| ADVA Clinical Research, Inc | Inglewood | California | 90301 | United States |
| Providence Clinical Research | North Hollywood | California | 91606 | United States |
| TCR Medical Corporation | San Diego | California | 92123 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Prohealth Research Center | Doral | Florida | 33166 | United States |
| Aby's New Generation Research, Inc. | Hialeah | Florida | 33016 | United States |
| Skin Care Research, LLC | Hollywood | Florida | 33021 | United States |
| Advanced Research Institute of Miami LLC | Homestead | Florida | 33030 | United States |
| Amber Pediatrics Research, LLC | Homestead | Florida | 33030 | United States |
| South Miami Medical & Research Group. Inc | Miami | Florida | 33155 | United States |
| Amber Pediatrics Research, LLC | Miami | Florida | 33169 | United States |
| Skin Research of South Florida | Miami | Florida | 33173 | United States |
| Amber Clinical Research, LLC | Miami Shores | Florida | 33138 | United States |
| IMA Clinical Research, LLC | St. Petersburg | Florida | 33709 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| Skin Sciences PLLC | Louisville | Kentucky | 40217 | United States |
| Quinn Healthcare/SKYCRNG | Ridgeland | Mississippi | 39157 | United States |
| Quality Clinical Research Inc | Omaha | Nebraska | 68114 | United States |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | United States |
| Greenwich Village Dermatology | New York | New York | 10012 | United States |
| ODRC Enterprises, LLC dba Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29369 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Gadolin Research | Beaumont | Texas | 77702 | United States |
| Modern Research Associates, PLLC | Dallas | Texas | 75231 | United States |
| FMC Science | Georgetown | Texas | 78626 | United States |
| FMC Science | Lampasas | Texas | 76550 | United States |
| Alliance for Multispecialty Research | Norfolk | Virginia | 23507 | United States |
| Clinical Research Partners, LLC | Richmond | Virginia | 23220 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Premier Specialists PTY LTD | Kogarah | New South Wales | 2217 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Double-blind Treatment Period: Etrasimod 2 mg |
Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
| FG002 | Double-blind Treatment Period: Placebo | Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
| FG003 | OLE Period: Etrasimod 2 mg | Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period. |
| COMPLETED |
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| NOT COMPLETED |
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| OLE Period (52-Week) |
|
|
Full Analysis Set (FAS) included all randomized participants, irrespective of whether they received any study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind Treatment Period: Etrasimod 1 Milligrams (mg) | Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
| BG001 | Double-blind Treatment Period: Etrasimod 2 mg | Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
| BG002 | Double-blind Treatment Period: Placebo | Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score | 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. | Full Analysis Set Population | Posted | Least Squares Mean | Standard Error | Percent change | Baseline (Day 1) and Week 12 |
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| Secondary | Double-blind Treatment Period: Percentage of Participants Achieving EASI-75 | 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. | Full Analysis Set Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) and Week 12 |
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| Secondary | 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 | 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. | Full Analysis Set Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) and Week 12 |
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| Secondary | Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary | 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. | Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed | Posted | Least Squares Mean | Standard Error | Percent change | Baseline (Day 1) and Week 12 |
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| Secondary | 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 | 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. | Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) and Week 12 |
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| Secondary | Double-blind Treatment Period: Percentage of Participants Achieving EASI-50 | 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. | Full Analysis Set Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) and Week 12 |
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| Secondary | Double-blind Treatment Period: Percentage of Participants Achieving EASI-90 | 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. | Full Analysis Set Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) and Week 12 |
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| Secondary | Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA) | 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 | Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline (Day 1) and Week 12 |
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| Secondary | Open-label Extension (OLE) Period: Percent Change in EASI | 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. | Safety Set Population included all randomized participants who received at least 1 dose of study intervention. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 16) and Week 68 |
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| Secondary | OLE Period: Number of Participants Achieving a EASI-75 Score | 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. | Safety Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Week 16) and Week 68 |
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| Secondary | OLE Period: Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of ≥ 2 Points | 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. | Safety Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Week 16) and Week 68 |
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| Secondary | OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score | 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. | Safety Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 16) and Week 68 |
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| Secondary | OLE Period: Percent Change in Percent BSA | 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. | Safety Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 16) and Week 68 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary | 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. | Safety Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 16) and Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OLE Period: Change in Patient-Oriented Eczema Measure (POEM) | 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. | Safety Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 16) and Week 68 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OLE Period: Change in Dermatology Life Quality Index (DLQI) | 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. | Safety Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 16) and Week 68 |
|
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| Secondary | OLE Period: Change in Patient Global Assessment (PGA) of Disease | 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. | Safety Set Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 16) and Week 68 |
|
|
All-cause mortality, TEAEs and SAEs were collected for Double-blind Treatment period (12-Week) and for OLE Period (52-Week).
Safety Population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-blind Treatment Period: Etrasimod 1 Milligrams (mg) | Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. | 0 | 47 | 0 | 47 | 19 | 47 |
| EG001 | Double-blind Treatment Period: Etrasimod 2 mg | Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. | 0 | 47 | 0 | 47 | 31 | 47 |
| EG002 | Double-blind Treatment Period: Placebo | Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. | 0 | 46 | 0 | 46 | 22 | 46 |
| EG003 | OLE Period: Etrasimod 2 mg | Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period. | 0 | 95 | 3 | 95 | 53 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extradural abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eyelid cyst | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infection parasitic | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Ear canal injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Coagulation factor increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Full blood count abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Procalcitonin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Essential tremor | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Quadriparesis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals, Inc. | +1 855-218-9153 | ct.gov@arenapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2021 | Aug 24, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656249 | etrasimod |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Protocol deviation |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| =0.1783 |
| Least square mean difference |
| -8.77 |
| Standard Error of the Mean |
| 6.515 |
| 2-Sided |
| 95 |
| -21.544 |
| 4.002 |
| Superiority |
|
|
|
| OG002 | Double-blind Treatment Period: Placebo | Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
|
|
|
Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
|
|
|
| OG002 | Double-blind Treatment Period: Placebo | Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
|
|
|
|
|
|
|
|
|
| Double-blind Treatment Period: Placebo |
Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
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|