Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, Etrasimod, APD334
Brief summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Interventions
DRUGEtrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
DRUGPlacebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Sponsors
Arena Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening 2. Active UC confirmed by endoscopy
Exclusion criteria
1. Severe extensive colitis 2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD 3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission at Week 12 | At Week 12 | Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving Clinical Remission at Week 52 | At Week 52 | Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Symptomatic Remission at Week 12 | At Week 12 | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. |
| Percentage of Participants Achieving Symptomatic Remission at Week 52 | At Week 52 | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. |
| Percentage of Participants With Mucosal Healing at Week 12 | At Week 12 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. |
| Percentage of Participants With Mucosal Healing at Week 52 | At Week 52 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. |
| Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52 | At Week 52 | Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52 | At Weeks 12 and 52 | Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving Clinical Response at Week 12 | At Week 12 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving Clinical Response at Week 52 | At Week 52 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB sub-score ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52 | At Weeks 12 and 52 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving Endoscopic Improvement at Week 12 | At Week 12 | Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). |
| Percentage of Participants Achieving Endoscopic Normalization at Week 12 | At Week 12 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). |
| Percentage of Participants Achieving Endoscopic Normalization at Week 52 | At Week 52 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). |
| Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52 | At Weeks 12 and 52 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). |
| Percentage of Participants Achieving Symptomatic Remission by Study Visit | At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48 | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. |
| Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52 | Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. |
| Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Non-invasive clinical response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores, and a ≥ 1-point decrease from Baseline in RB subscore or RB subscore ≤ 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving Symptomatic Response by Study Visit | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Symptomatic response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline | At Week 52 | Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1, and have not received corticosteroids for ≥ 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12 | At Week 52 | Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. |
| Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52 | At Weeks 12 and 52 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. |
| Percentage of Participants Achieving Endoscopic Improvement at Week 52 | At Week 52 | Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Latvia, Lebanon, Lithuania, Mexico, Moldova, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants with moderately to severely active ulcerative colitis (UC) were enrolled in this study. Eligible participants were randomized in a 2:1 ratio to receive either etrasimod 2 milligrams (mg) once daily or matching placebo once daily for up to 52 weeks.
Pre-assignment details
The study included a Screening Period (up to 28 days), a 12-Week Treatment Period (induction) followed by a 40-Week Treatment Period (maintenance; for which no re-randomization took place), and a 2-Week and 4-Week Follow-Up Period.
Participants by arm
| Arm | Count |
|---|---|
| Etrasimod 2 mg Etrasimod 2 mg was administered orally once daily for up to 52 weeks. | 289 |
| Placebo Placebo was administered orally once daily for up to 52 weeks. | 144 |
| Total | 433 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 5 |
| Overall Study | Disease worsening | 79 | 73 |
| Overall Study | Lack of Efficacy | 7 | 4 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Other | 2 | 2 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Pregnancy | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by participant or parent/guardian | 24 | 10 |
Baseline characteristics
| Characteristic | Total | Etrasimod 2 mg | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 27 Participants | 17 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 405 Participants | 272 Participants | 133 Participants |
| Age, Continuous | 40.4 Years STANDARD_DEVIATION 14.02 | 41.2 Years STANDARD_DEVIATION 13.97 | 38.9 Years STANDARD_DEVIATION 14.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 411 Participants | 275 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 31 Participants | 22 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) White | 385 Participants | 256 Participants | 129 Participants |
| Sex: Female, Male Female | 193 Participants | 137 Participants | 56 Participants |
| Sex: Female, Male Male | 240 Participants | 152 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 289 | 0 / 144 |
| other Total, other adverse events | 204 / 289 | 77 / 144 |
| serious Total, serious adverse events | 20 / 289 | 9 / 144 |
Outcome results
Primary
Percentage of Participants Achieving Clinical Remission at Week 12
Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Week 12
Population: FAS (consisting of all randomized participants who received at least 1 dose of study treatment) with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Clinical Remission at Week 12 | 27.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Clinical Remission at Week 12 | 7.4 Percentage of participants |
p-value: <0.00195% CI: [12.88, 26.63]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Achieving Clinical Remission at Week 52
Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Clinical Remission at Week 52 | 32.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Clinical Remission at Week 52 | 6.7 Percentage of participants |
p-value: <0.00195% CI: [18.42, 32.36]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline
Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1, and have not received corticosteroids for ≥ 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9. Only participants receiving corticosteroids at study entry and who had not been receiving corticosteroids for ≥ 4 weeks prior to Week 52 were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline | 31.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline | 7.5 Percentage of participants |
p-value: <0.00195% CI: [10.2, 35.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12
Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9. Only participants in clinical response at Week 12 were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12 | 49.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12 | 17.4 Percentage of participants |
p-value: <0.00195% CI: [18.45, 45.28]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Weeks 12 and 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52 | 44.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52 | 18.5 Percentage of participants |
p-value: <0.00195% CI: [17.48, 34.84]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Clinical Response at Week 12
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Week 12
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Clinical Response at Week 12 | 62.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Clinical Response at Week 12 | 34.1 Percentage of participants |
p-value: <0.00195% CI: [18.51, 38.02]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Clinical Response at Week 52
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB sub-score ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Clinical Response at Week 52 | 48.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Clinical Response at Week 52 | 23.0 Percentage of participants |
p-value: <0.00195% CI: [15.79, 34.07]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 12 | 23.0 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 24 | 22.3 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 8 | 16.8 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 32 | 23.0 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 16 | 21.2 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 40 | 21.2 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 4 | 11.3 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 48 | 19.7 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 20 | 22.3 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 52 | 24.5 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 2 | 5.8 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 52 | 4.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 2 | 2.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 4 | 4.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 8 | 6.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 12 | 6.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 16 | 5.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 20 | 4.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 24 | 8.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 32 | 3.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 40 | 5.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Week 48 | 2.2 Percentage of participants |
Comparison: Week 2p-value: =0.05795% CI: [-0.11, 7.3]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: =0.00795% CI: [1.86, 11.9]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: =0.00195% CI: [4.09, 16.2]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.00195% CI: [9.89, 22.83]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.00195% CI: [9.23, 21.52]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.00195% CI: [11.85, 23.75]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.00195% CI: [7.45, 21.04]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.00195% CI: [14.25, 25.81]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: <0.00195% CI: [8.91, 21.35]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: <0.00195% CI: [12.16, 22.87]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: <0.00195% CI: [13.75, 25.98]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52
Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52 | 32.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52 | 6.7 Percentage of participants |
p-value: <0.00195% CI: [18.42, 32.36]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Endoscopic Improvement at Week 12
Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
Time frame: At Week 12
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Endoscopic Improvement at Week 12 | 35.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Endoscopic Improvement at Week 12 | 14.1 Percentage of participants |
p-value: <0.00195% CI: [13.03, 29.32]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Endoscopic Improvement at Week 52
Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Endoscopic Improvement at Week 52 | 37.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Endoscopic Improvement at Week 52 | 10.4 Percentage of participants |
p-value: <0.00195% CI: [18.99, 34.39]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Time frame: At Weeks 12 and 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52 | 10.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52 | 1.5 Percentage of participants |
p-value: <0.00195% CI: [4.93, 13.38]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Endoscopic Normalization at Week 12
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Time frame: At Week 12
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Endoscopic Normalization at Week 12 | 14.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving Endoscopic Normalization at Week 12 | 4.4 Percentage of participants |
p-value: <0.00195% CI: [4.73, 15.73]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Endoscopic Normalization at Week 52
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Endoscopic Normalization at Week 52 | 26.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Endoscopic Normalization at Week 52 | 5.9 Percentage of participants |
p-value: <0.00195% CI: [13.79, 26.98]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Non-invasive clinical response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores, and a ≥ 1-point decrease from Baseline in RB subscore or RB subscore ≤ 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 12 | 65.7 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 24 | 56.6 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 8 | 63.1 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 32 | 54.0 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 16 | 55.5 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 40 | 51.5 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 4 | 56.2 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 48 | 51.1 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 20 | 57.3 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 52 | 50.4 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 2 | 38.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 52 | 23.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 2 | 33.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 4 | 39.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 8 | 43.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 12 | 42.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 16 | 30.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 20 | 28.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 24 | 30.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 32 | 25.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 40 | 23.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Week 48 | 21.5 Percentage of participants |
Comparison: Week 2p-value: =0.33695% CI: [-5.01, 14.68]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.00195% CI: [7.06, 27.15]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.00195% CI: [10.15, 30.19]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.00195% CI: [13.45, 33.43]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.00195% CI: [15.67, 34.83]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.00195% CI: [19.77, 38.64]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.00195% CI: [16.47, 35.69]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.00195% CI: [19.35, 38.02]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: <0.00195% CI: [19.3, 37.55]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: <0.00195% CI: [20.55, 38.64]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: <0.00195% CI: [17.18, 35.68]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52
Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time frame: At Weeks 12 and 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52 | 17.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52 | 2.2 Percentage of participants |
p-value: <0.00195% CI: [10.66, 21.03]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Symptomatic Remission at Week 12
Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Time frame: At Week 12
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission at Week 12 | 46.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission at Week 12 | 21.5 Percentage of participants |
p-value: <0.00195% CI: [15.46, 33.63]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Symptomatic Remission at Week 52
Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission at Week 52 | 43.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission at Week 52 | 18.5 Percentage of participants |
p-value: <0.00195% CI: [16.17, 33.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Time frame: At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 4 | 28.1 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 24 | 44.9 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 16 | 43.1 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 32 | 44.5 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 8 | 37.6 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 40 | 42.0 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 20 | 43.8 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 48 | 42.0 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 2 | 15.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 48 | 15.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 2 | 8.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 4 | 13.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 8 | 20.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 16 | 21.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 20 | 20.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 24 | 23.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 32 | 18.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Week 40 | 18.5 Percentage of participants |
Comparison: Week 2p-value: =0.04995% CI: [0.02, 12.95]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.00195% CI: [7.32, 22.74]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.00195% CI: [8.06, 25.63]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.00195% CI: [12.71, 30.61]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.00195% CI: [14.98, 32.51]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.00195% CI: [11.83, 30.24]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.00195% CI: [17.08, 34.56]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: <0.00195% CI: [14.8, 32.14]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: <0.00195% CI: [17.92, 34.82]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Symptomatic Response by Study Visit
Symptomatic response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
Time frame: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 2 | 39.4 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 4 | 57.3 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 8 | 64.6 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 12 | 66.4 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 16 | 55.5 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 20 | 57.7 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 32 | 54.7 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 40 | 51.8 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 48 | 51.5 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 52 | 50.7 Percentage of participants |
| Etrasimod 2 mg | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 24 | 56.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 20 | 28.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 2 | 33.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 24 | 30.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 4 | 40.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 52 | 23.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 8 | 43.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 32 | 25.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 12 | 42.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 48 | 21.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 16 | 31.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Symptomatic Response by Study Visit | Week 40 | 23.0 Percentage of participants |
Comparison: Week 2p-value: =0.2495% CI: [-3.96, 15.81]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.00195% CI: [7.48, 27.53]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.00195% CI: [10.92, 30.94]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.00195% CI: [14.15, 34.1]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.00195% CI: [14.89, 34.13]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.00195% CI: [20.13, 39.01]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.00195% CI: [16.88, 36.02]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.00195% CI: [20.01, 38.68]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: <0.00195% CI: [19.71, 37.95]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: <0.00195% CI: [20.97, 39.03]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: <0.00195% CI: [17.6, 36.07]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52
Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Time frame: At Weeks 12 and 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52 | 13.5 Percentage of participants |
| Placebo | Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52 | 2.2 Percentage of participants |
p-value: <0.00195% CI: [6.49, 16.14]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Mucosal Healing at Week 12
Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Time frame: At Week 12
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants With Mucosal Healing at Week 12 | 21.2 Percentage of participants |
| Placebo | Percentage of Participants With Mucosal Healing at Week 12 | 4.4 Percentage of participants |
p-value: <0.00195% CI: [10.78, 22.98]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Mucosal Healing at Week 52
Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
Time frame: At Week 52
Population: FAS with actual Baseline MMS 5 to 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etrasimod 2 mg | Percentage of Participants With Mucosal Healing at Week 52 | 26.6 Percentage of participants |
| Placebo | Percentage of Participants With Mucosal Healing at Week 52 | 8.1 Percentage of participants |
p-value: <0.00195% CI: [11.39, 25.39]Cochran-Mantel-Haenszel