Clinical Trials List
Protocol NumberES101002
2019-09-15 - 2024-01-30
Phase III
Recruiting6
Terminated1
ICD-10K51.90
Ulcerative colitis, unspecified, without complications
ICD-10K51.911
Ulcerative colitis, unspecified with rectal bleeding
ICD-10K51.912
Ulcerative colitis, unspecified with intestinal obstruction
ICD-10K51.913
Ulcerative colitis, unspecified with fistula
ICD-10K51.914
Ulcerative colitis, unspecified with abscess
ICD-10K51.918
Ulcerative colitis, unspecified with other complication
ICD-10K51.919
Ulcerative colitis, unspecified with unspecified complications
ICD-9556.9
Ulcerative colitis, unspecified
A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects with Moderately to Severely Active Ulcerative Colitis
-
Trial Applicant
COVANCE TAIWAN SERVICES LIMITED
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 許振銘 無
- Chia-Jung Kuo 無
- Cheng-Yu Lin 無
- Ming-Yao Su 無
- Yih-Shiou Hwang 無
- Puo-Hsien Le 無
- Wen-Sy Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- 翁昭旼 無
- 翁孟慈 無
- TSO-TING LAI 無
- 謝銘鈞 無
- CHIEN-CHIH TUNG 無
- YEN-HSUAN NI 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Moderately to Severely Active Ulcerative Colitis
Objectives
Primary Objective
- To demonstrate the efficacy of etrasimod, as compared with placebo, on clinical remission at induction period week 12 in patients with moderately to severely active ulcerative colitis (UC).
Key Secondary Objectives
- To demonstrate the efficacy of etrasimod, as compared with placebo on endoscopic improvement at induction period week 12 in patients with moderately to severely active UC
- To demonstrate the efficacy of etrasimod, as compared with placebo, on clinical response at induction period week 12 in patients with moderately to severely active UC
Test Drug
Etrasimod
Active Ingredient
Etrasimod L- arginine
Dosage Form
tablet
Dosage
2mg
Endpoints
Primary Objective
- To demonstrate the efficacy of etrasimod, as compared with
placebo, on clinical remission at induction period week 12 in
patients with moderately to severely active ulcerative colitis
(UC).
Key Secondary Objectives
- To demonstrate the efficacy of etrasimod, as compared with
placebo on endoscopic improvement at induction period week
12 in patients with moderately to severely active UC
- To demonstrate the efficacy of etrasimod, as compared with
placebo, on clinical response at induction period week 12 in
patients with moderately to severely active UC
Other Secondary Objectives
To evaluate the efficacy of etrasimod, as compared with placebo on:
- endoscopic normalization
- symptomatic response
- symptomatic remission
- noninvasive clinical response
- mucosal healing
Other Objectives
- To explore the efficacy of etrasimod treatment on change in
total Mayo score
- To analyze key endpoints in the subgroup of patients on
concomitant therapies, including corticosteroids and 5-ASA
- To explore the effect of etrasimod treatment on reduction in
biomarker
- To assess the pharmacodynamic characteristics of etrasimod
- To assess the effect of etrasimod treatment on health-related
quality of life (QOL) at week 12 at induction period.
- To assess the effect of etrasimod treatment on histologic outcome
- To demonstrate the efficacy of etrasimod, as compared with
placebo, on clinical remission at induction period week 12 in
patients with moderately to severely active ulcerative colitis
(UC).
Key Secondary Objectives
- To demonstrate the efficacy of etrasimod, as compared with
placebo on endoscopic improvement at induction period week
12 in patients with moderately to severely active UC
- To demonstrate the efficacy of etrasimod, as compared with
placebo, on clinical response at induction period week 12 in
patients with moderately to severely active UC
Other Secondary Objectives
To evaluate the efficacy of etrasimod, as compared with placebo on:
- endoscopic normalization
- symptomatic response
- symptomatic remission
- noninvasive clinical response
- mucosal healing
Other Objectives
- To explore the efficacy of etrasimod treatment on change in
total Mayo score
- To analyze key endpoints in the subgroup of patients on
concomitant therapies, including corticosteroids and 5-ASA
- To explore the effect of etrasimod treatment on reduction in
biomarker
- To assess the pharmacodynamic characteristics of etrasimod
- To assess the effect of etrasimod treatment on health-related
quality of life (QOL) at week 12 at induction period.
- To assess the effect of etrasimod treatment on histologic outcome
Inclution Criteria
1. Males or female patients aged 18 to 75 years (both inclusive);
2. Provide written informed consent with date and signature
3. A documented of diagnosis with UC at least 6 months prior to
screening. The diagnosis of UC must be confirmed by endoscopic and
histologic evidence. The endoscopy and histology report should be
present in the source documents; however, if not available, the
screening endoscopy and histology may serve as such
4. Moderately to severely active UC defined as mMS of 4-9 (inclusive)with an endoscopy subscore of ≥ 2 and a rectal bleeding
subsore≥1determined within 10 days prior to the first dose of study
drug
5. Have active UC extending proximal to the rectum confirmed on
endoscopy (≥ 15 cm of involved colon)
6. If the patient has extensive colitis >8 years or left side of colon >12
years, regardless of age, a colonoscopy within 1 year of the screening
visit is required. Patients with dysplasia or cancer or adenomatous
polyps identified on biopsies will be excluded
Prior treatment failure criteria
7. Demonstrated, over the previous 5-year period, an inadequate response
to, loss of response to, or intolerance of at least one of the following
agents as defined below:
Conventional therapy
Corticosteroids
- Signs and symptoms of persistently active disease despite a history of
IV given prednisone ≥40mg/d (or prednisone equivalent dose)for at
least 1-week , or oral prednisone >20mg/d (or prednisone equivalent
dose)for at least 4-week OR
- Failed one attempt to taper corticosteroids to prednisone≥10 mg/d (or
prednisone equivalent dose) within 3 months OR
- Relapse within 3 months of completing a course of corticosteroids and
stopping corticosteroids OR
- History of intolerance of corticosteroids (including, but not limited to
Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia,insomnia, and infection)
Immunosuppressive
- Signs and symptoms of persistently active disease despite a history of
at least one 3-month regimen of oral azathioprine (≥
1mg/kg/d) ,6-mercaptopurine (≥ 0.5 mg/kg/d), methotrexate (≥ 15
mg/week) OR
- History of intolerance of at least one of these immunosuppressive
(including, but not limited to nausea/vomiting, abdominal pain,
pancreatitis, liver function test abnormalities, lymphopenia, thiopurine
S-methyltransferase (TPMT) or NUDT15 genetic mutation, infection)
Biologic therapy (TNFα antagonists, anti-integrin antibodies) or JAK
inhibitors
- Inadequate response: Signs and symptoms of persistently active
disease despite a history of completing an induction regimen at doses
per the current labeling and/or Institutional standard of care OR
- Loss of response: Recurrence of symptoms during maintenance
dosing following prior clinical benefit (discontinuation despite clinical
benefit does not qualify) OR
- Intolerance: Including, but not limited to infusion- or injection- related
reaction, demyelination, congestive heart failure, infection or other
related adverse event that led to a reduction in dose or discontinuation
of the medication Concomitant therapy
8. Patients are permitted to be receiving a therapeutic dose of the
following drugs:
- Oral 5-ASA compounds provided that the dose has been stable for
≥ 2 weeks immediately prior to endoscopy assessment
- Oral corticosteroid therapy (prednisone at a stable dose ≤ 20 mg/day, or
equivalent steroid) provided that the dose has been stable for the 4
weeks immediately prior to screening endoscopy assessment
- Immunosuppressive agents (AZA ,6-MP) at screening, provided the
dose has been stable for the 3 months immediately prior to screening
(These immunosuppressive agents must be discontinued ≥ 2 weeks
prior to randomization)
- Antidiarrheals (e.g., loperamide, diphenoxylate with atropine) for
control of chronic diarrhea
9. If oral aminosalicylates or corticosteroids have been recently
discontinued, they must have been stopped for at least 2 weeks prior to
the endoscopy used for baseline modified Mayo Score;
General criteria
10. Women of childbearing potential (WOCBP) must be using an
adequate method of contraception to avoid pregnancy throughout the
study and for at least 30 days after the last dose of study medication.
Men participating in the study should also take precautions as
described above to not father a baby while participating in the study
and at least 30 days after the last dose of study medication.
who has not undergone successful surgical sterilization
(hysterectomy, bilateral tubal ligation or bilateral oophorectomy);
or is not postmenopausal (postmenopausal defined as amenorrhea
≥ 12 consecutive months following cessation of all exogenous
hormonal treatments).
Even women who are using oral, implanted or injectable
contraceptive hormones or mechanical products such as an
intrauterine device or barrier methods (e.g.,diaphragm, condoms,
spermicides,etc.) to prevent pregnancy or practicing abstinence or
where partner is sterile (e.g., vasectomy), should be considered to
be of child bearing potential.
11. Adequate hematologic function defined as: White blood cell count
≥3.5X109
/L with neutrophil count ≥1.5X109
/L, lymphocyte
count≥0.8X109
/L, platelet count ≥100X109
/L, hemoglobin ≥ 9g/L
12. Adequate liver function defined as: alanine aminotransferase
(ALT)/aspartate aminotransferase (AST)≤ 2X upper limit of normal
(ULN), total bilirubin (TBL)≤1.5 ULN. Patients with TBL>1.5X ULN
and normal ALT/AST, have documented as Gilbert’s syndrome may
participate
13. Adequate renal function defined by an estimated glomerular filtration
rate>30ml/min/1.73 m2 according to CKD-EPI equation at screening
2. Provide written informed consent with date and signature
3. A documented of diagnosis with UC at least 6 months prior to
screening. The diagnosis of UC must be confirmed by endoscopic and
histologic evidence. The endoscopy and histology report should be
present in the source documents; however, if not available, the
screening endoscopy and histology may serve as such
4. Moderately to severely active UC defined as mMS of 4-9 (inclusive)with an endoscopy subscore of ≥ 2 and a rectal bleeding
subsore≥1determined within 10 days prior to the first dose of study
drug
5. Have active UC extending proximal to the rectum confirmed on
endoscopy (≥ 15 cm of involved colon)
6. If the patient has extensive colitis >8 years or left side of colon >12
years, regardless of age, a colonoscopy within 1 year of the screening
visit is required. Patients with dysplasia or cancer or adenomatous
polyps identified on biopsies will be excluded
Prior treatment failure criteria
7. Demonstrated, over the previous 5-year period, an inadequate response
to, loss of response to, or intolerance of at least one of the following
agents as defined below:
Conventional therapy
Corticosteroids
- Signs and symptoms of persistently active disease despite a history of
IV given prednisone ≥40mg/d (or prednisone equivalent dose)for at
least 1-week , or oral prednisone >20mg/d (or prednisone equivalent
dose)for at least 4-week OR
- Failed one attempt to taper corticosteroids to prednisone≥10 mg/d (or
prednisone equivalent dose) within 3 months OR
- Relapse within 3 months of completing a course of corticosteroids and
stopping corticosteroids OR
- History of intolerance of corticosteroids (including, but not limited to
Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia,insomnia, and infection)
Immunosuppressive
- Signs and symptoms of persistently active disease despite a history of
at least one 3-month regimen of oral azathioprine (≥
1mg/kg/d) ,6-mercaptopurine (≥ 0.5 mg/kg/d), methotrexate (≥ 15
mg/week) OR
- History of intolerance of at least one of these immunosuppressive
(including, but not limited to nausea/vomiting, abdominal pain,
pancreatitis, liver function test abnormalities, lymphopenia, thiopurine
S-methyltransferase (TPMT) or NUDT15 genetic mutation, infection)
Biologic therapy (TNFα antagonists, anti-integrin antibodies) or JAK
inhibitors
- Inadequate response: Signs and symptoms of persistently active
disease despite a history of completing an induction regimen at doses
per the current labeling and/or Institutional standard of care OR
- Loss of response: Recurrence of symptoms during maintenance
dosing following prior clinical benefit (discontinuation despite clinical
benefit does not qualify) OR
- Intolerance: Including, but not limited to infusion- or injection- related
reaction, demyelination, congestive heart failure, infection or other
related adverse event that led to a reduction in dose or discontinuation
of the medication Concomitant therapy
8. Patients are permitted to be receiving a therapeutic dose of the
following drugs:
- Oral 5-ASA compounds provided that the dose has been stable for
≥ 2 weeks immediately prior to endoscopy assessment
- Oral corticosteroid therapy (prednisone at a stable dose ≤ 20 mg/day, or
equivalent steroid) provided that the dose has been stable for the 4
weeks immediately prior to screening endoscopy assessment
- Immunosuppressive agents (AZA ,6-MP) at screening, provided the
dose has been stable for the 3 months immediately prior to screening
(These immunosuppressive agents must be discontinued ≥ 2 weeks
prior to randomization)
- Antidiarrheals (e.g., loperamide, diphenoxylate with atropine) for
control of chronic diarrhea
9. If oral aminosalicylates or corticosteroids have been recently
discontinued, they must have been stopped for at least 2 weeks prior to
the endoscopy used for baseline modified Mayo Score;
General criteria
10. Women of childbearing potential (WOCBP) must be using an
adequate method of contraception to avoid pregnancy throughout the
study and for at least 30 days after the last dose of study medication.
Men participating in the study should also take precautions as
described above to not father a baby while participating in the study
and at least 30 days after the last dose of study medication.
who has not undergone successful surgical sterilization
(hysterectomy, bilateral tubal ligation or bilateral oophorectomy);
or is not postmenopausal (postmenopausal defined as amenorrhea
≥ 12 consecutive months following cessation of all exogenous
hormonal treatments).
Even women who are using oral, implanted or injectable
contraceptive hormones or mechanical products such as an
intrauterine device or barrier methods (e.g.,diaphragm, condoms,
spermicides,etc.) to prevent pregnancy or practicing abstinence or
where partner is sterile (e.g., vasectomy), should be considered to
be of child bearing potential.
11. Adequate hematologic function defined as: White blood cell count
≥3.5X109
/L with neutrophil count ≥1.5X109
/L, lymphocyte
count≥0.8X109
/L, platelet count ≥100X109
/L, hemoglobin ≥ 9g/L
12. Adequate liver function defined as: alanine aminotransferase
(ALT)/aspartate aminotransferase (AST)≤ 2X upper limit of normal
(ULN), total bilirubin (TBL)≤1.5 ULN. Patients with TBL>1.5X ULN
and normal ALT/AST, have documented as Gilbert’s syndrome may
participate
13. Adequate renal function defined by an estimated glomerular filtration
rate>30ml/min/1.73 m2 according to CKD-EPI equation at screening
Exclusion Criteria
Gastrointestinal exclusion criteria
1. Have severe extensive colitis as evidenced by
- Physician judgement that the patient is likely to require hospitalization
for medical care or surgical intervention for UC (e.g., colectomy)
within 12 weeks of randomization OR
- Current evidence of fulminant colitis, toxic megacolon or recent
history (within 6 months) of toxic megacolon, or bowel perforation OR
- Previous extensive colectomy (subtotal or total colectomy)
2. Diagnosis of Crohn’s colitis or indeterminate colitis or the presence or
history of a fistula consistent with Crohn’s disease
3. Hospitalization for flare of UC requiring intravenous steroids within 12
weeks of screening (a single dose of IV steroids given at an emergency
room is acceptable)
4. Diagnosis of microscopic colitis, ischemic colitis, infection colitis or
colonic mucosal dysplasia;
5. Have positive stool culture for pathogens (ova or parasite examination,
bacteria) or positive test for C. difficile toxin at screening (If C.
difficile is positive, the patient may be treated and retested ≥ 4 weeks
after completing treatment)
6. UC opportunistic infection (cytomegalovirus infection or Epstein-Barr
virus) can’t excluded per investigator’s clinical judgment at screening
Medications related exclusion criteria
7. Prior treatment with S1P modulator
8. Within 30 days (or 5 half-lives, whichever is longer) prior to
randomization, receipt of any of the non-biologic investigational agents
9. Within 8 weeks (or 5 half-lives, whichever is longer) prior to
randomization, receipt of any of the biologic agents
10. Use of topical (rectal)treatment with 5-ASA, corticosteroid or
traditional medicine/herb enemas/suppositories within 2 weeks of
screening
11. Previous treatment with lymphocyte-depleting therapies (e.g.,
rituximab, cyclophosphamide, total body irradiation, bone marrow
transplantation)
12. Previous treatment with D-penicillamine, leflunomide or thalidomide
13. History of treatment with intravenous immune globulin,
plasmapheresis, within 3 months prior to randomization;
14. Have had treatment with cyclosporine, tacrolimus, methotrexate,
sirolimus, or mycophenolate mofetil (MMF) within 16 weeks of
screening
15. Previous treatment with natalizumab
16. Use medications that are moderate or strong cytochrome (CYP)450
2C8 、 2C9 inducers/inhibitors ,or UGT 1A7 inhibitors within 4
weeks prior to randomization
17. Receipt of live vaccine within 4 weeks prior to screening
18. Known active infection that required hospitalization or treatment with
intravenous anti-infection treatment within 30 days of screening or oral
anti-infection treatment within 14 days prior to screening. Fungal
infection of nail beds is allowed19. Consecutive, regular using nonsteroidal anti-inflammatory drug
(NSAID) use within 8 weeks prior to screening (Occasional use of
NSAIDs for headache, arthritis, myalgias, menstrual cramps, etc., is
permitted)
Cardiac related criteria
20. Recent history (within 2 months of screening visit) of cardiovascular or
cerebrovascular disease including myocardial infarction, unstable
angina, stroke, or transient ischemia attack, or any of the below:
- History or presence of clinically significant atrial or ventricular
arrhythmias might need treatment
- History or presence of clinically significant cardiovascular conduction
system disease, including but not limit to second or third-degree
atrioventricular block, or sick sinus syndrome
- History or presence of symptomatic bradycardia
- History of syncope
Any concomitant medication with a known impact on the cardiac
conduction system and QT prolonging drugs with a known risk of
torsades de pointes
Medical history/condition related exclusion criteria
21. History of retinal macular edema or other retinal disorders
22. History of malignancy in the past 5 years, with the exception for basal
cell skin cancer and in situ squamous cell cancer of the skin that have
been excised and resolved
23. History of clinically significant leukopenia or lymphopenia at
screening.
24. History of lymphoproliferative disorder, lymphoma, leukemia,
myeloproliferative disorder, or multiple myeloma
25. Have HBV or HCV infection at screening (HBsAg +, or HBsAg- with
detectable HBV DNA; HCV antibody + with detectable HCV RNA)
26. Any identified congenital or acquired immunodeficiency (e.g. common
variable immunodeficiency, HIV infection, organ transplantation)
27. Subjects with a history of more than one episode of herpes zoster, or a
history of disseminated herpes zoster or disseminated herpes simplex;
28. Evidence of active or latent tuberculosis (TB) prior to randomization as
defined by:
- Having history of diagnosed latent or active TB infection
- A positive TB test at screening defined as
A positive QuantiFERON test
OR
- Chest X-ray or chest CT at screening can’t exclude active or latent
pulmonary tuberculosis
29. FEV1 or FVC value of pulmonary function test <70% of predicted values
and FEV1/FVC ratio <0.70 at screening
30. Uncontrolled diabetes as determined by hemoglobin A1c
(HbA1c) > 9% at screening, or subjects with diabetes with significant
comorbid conditions such as retinopathy
General exclusion criteria
31. Women who are breast feeding or have a positive serum pregnancy test
at screening visit
32. History of alcohol abuse or drug abuse within 1 year prior to
randomization
33. History of hypersensitivity to any active or inactive ingredient of
etrasimod tablets
34. Any disease or condition that, in the opinion of the investigator, would
compromise the safety of the patient or interfere with study
assessments
35. Individuals at risk for protocol or medication compliance
36. Involvement in study planning and conduct (e.g. sponsor staff or staff
at the study site)
1. Have severe extensive colitis as evidenced by
- Physician judgement that the patient is likely to require hospitalization
for medical care or surgical intervention for UC (e.g., colectomy)
within 12 weeks of randomization OR
- Current evidence of fulminant colitis, toxic megacolon or recent
history (within 6 months) of toxic megacolon, or bowel perforation OR
- Previous extensive colectomy (subtotal or total colectomy)
2. Diagnosis of Crohn’s colitis or indeterminate colitis or the presence or
history of a fistula consistent with Crohn’s disease
3. Hospitalization for flare of UC requiring intravenous steroids within 12
weeks of screening (a single dose of IV steroids given at an emergency
room is acceptable)
4. Diagnosis of microscopic colitis, ischemic colitis, infection colitis or
colonic mucosal dysplasia;
5. Have positive stool culture for pathogens (ova or parasite examination,
bacteria) or positive test for C. difficile toxin at screening (If C.
difficile is positive, the patient may be treated and retested ≥ 4 weeks
after completing treatment)
6. UC opportunistic infection (cytomegalovirus infection or Epstein-Barr
virus) can’t excluded per investigator’s clinical judgment at screening
Medications related exclusion criteria
7. Prior treatment with S1P modulator
8. Within 30 days (or 5 half-lives, whichever is longer) prior to
randomization, receipt of any of the non-biologic investigational agents
9. Within 8 weeks (or 5 half-lives, whichever is longer) prior to
randomization, receipt of any of the biologic agents
10. Use of topical (rectal)treatment with 5-ASA, corticosteroid or
traditional medicine/herb enemas/suppositories within 2 weeks of
screening
11. Previous treatment with lymphocyte-depleting therapies (e.g.,
rituximab, cyclophosphamide, total body irradiation, bone marrow
transplantation)
12. Previous treatment with D-penicillamine, leflunomide or thalidomide
13. History of treatment with intravenous immune globulin,
plasmapheresis, within 3 months prior to randomization;
14. Have had treatment with cyclosporine, tacrolimus, methotrexate,
sirolimus, or mycophenolate mofetil (MMF) within 16 weeks of
screening
15. Previous treatment with natalizumab
16. Use medications that are moderate or strong cytochrome (CYP)450
2C8 、 2C9 inducers/inhibitors ,or UGT 1A7 inhibitors within 4
weeks prior to randomization
17. Receipt of live vaccine within 4 weeks prior to screening
18. Known active infection that required hospitalization or treatment with
intravenous anti-infection treatment within 30 days of screening or oral
anti-infection treatment within 14 days prior to screening. Fungal
infection of nail beds is allowed19. Consecutive, regular using nonsteroidal anti-inflammatory drug
(NSAID) use within 8 weeks prior to screening (Occasional use of
NSAIDs for headache, arthritis, myalgias, menstrual cramps, etc., is
permitted)
Cardiac related criteria
20. Recent history (within 2 months of screening visit) of cardiovascular or
cerebrovascular disease including myocardial infarction, unstable
angina, stroke, or transient ischemia attack, or any of the below:
- History or presence of clinically significant atrial or ventricular
arrhythmias might need treatment
- History or presence of clinically significant cardiovascular conduction
system disease, including but not limit to second or third-degree
atrioventricular block, or sick sinus syndrome
- History or presence of symptomatic bradycardia
- History of syncope
Any concomitant medication with a known impact on the cardiac
conduction system and QT prolonging drugs with a known risk of
torsades de pointes
Medical history/condition related exclusion criteria
21. History of retinal macular edema or other retinal disorders
22. History of malignancy in the past 5 years, with the exception for basal
cell skin cancer and in situ squamous cell cancer of the skin that have
been excised and resolved
23. History of clinically significant leukopenia or lymphopenia at
screening.
24. History of lymphoproliferative disorder, lymphoma, leukemia,
myeloproliferative disorder, or multiple myeloma
25. Have HBV or HCV infection at screening (HBsAg +, or HBsAg- with
detectable HBV DNA; HCV antibody + with detectable HCV RNA)
26. Any identified congenital or acquired immunodeficiency (e.g. common
variable immunodeficiency, HIV infection, organ transplantation)
27. Subjects with a history of more than one episode of herpes zoster, or a
history of disseminated herpes zoster or disseminated herpes simplex;
28. Evidence of active or latent tuberculosis (TB) prior to randomization as
defined by:
- Having history of diagnosed latent or active TB infection
- A positive TB test at screening defined as
A positive QuantiFERON test
OR
- Chest X-ray or chest CT at screening can’t exclude active or latent
pulmonary tuberculosis
29. FEV1 or FVC value of pulmonary function test <70% of predicted values
and FEV1/FVC ratio <0.70 at screening
30. Uncontrolled diabetes as determined by hemoglobin A1c
(HbA1c) > 9% at screening, or subjects with diabetes with significant
comorbid conditions such as retinopathy
General exclusion criteria
31. Women who are breast feeding or have a positive serum pregnancy test
at screening visit
32. History of alcohol abuse or drug abuse within 1 year prior to
randomization
33. History of hypersensitivity to any active or inactive ingredient of
etrasimod tablets
34. Any disease or condition that, in the opinion of the investigator, would
compromise the safety of the patient or interfere with study
assessments
35. Individuals at risk for protocol or medication compliance
36. Involvement in study planning and conduct (e.g. sponsor staff or staff
at the study site)
The Estimated Number of Participants
-
Taiwan
15 participants
-
Global
333 participants
