A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 379
- 试验地点
- 989
- 主要终点
- Proportion of Participants with Endoscopic Response [Substudy A]
研究概览
简要总结
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.
详细描述
This study includes 5 substudies:
Substudy A - Phase 2: A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in participants with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3.
Substudy 1 - Phase 2: A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3.
Substudy 2 - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy.
Substudy 3 - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy. Participants from Substudy 1 and Substudy 2 will be enrolled in Substudy 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria applicable to all substudies:
- •Inclusion Criteria:
- •Men or women 18 to 80 years of age,
- •Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
- •Diagnosed with Crohn's disease (CD) ≥ 3 months
- •Have moderately to severely active CD at Screening
- •Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD:
- •Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
- •Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6-MP], or methotrexate [MTX])
- •Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
- •Integrin receptor antagonist (eg, vedolizumab)
- •Interleukin -12/-23 antagonist (eg, ustekinumab)
- •Females of childbearing potential must be nonpregnant
- •Females of childbearing potential and males must use contraception
排除标准
- •History of inadequate response (ie, primary non-response) to agents from ≥ 2 classes of biologics marketed for the treatment of CD (ie, TNFα antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
- •Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening.
- •Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
- •Had surgical treatment for intra abdominal abscesses ≤ 8 weeks prior to randomization or surgical treatment for perianal abscesses ≤ 4 weeks prior to randomization.
- •Had intestinal resection ≤ 24 weeks prior to randomization or other intra abdominal surgeries ≤ 12 weeks prior to randomization.
- •Have an ileostomy or a colostomy.
- •Inclusion Criteria for Substudy 3:
- •- Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit
- •Inclusion Criteria for Substudy 4:
- •- Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Etrasimod Dose A
干预措施: Etrasimod (Drug)
Etrasimod Dose B
干预措施: Etrasimod (Drug)
结局指标
主要结局
Proportion of Participants with Endoscopic Response [Substudy A]
时间窗: Weeks 14 and 52
Proportion of Participants With Clinical Remission CDAI [Substudy 3]
时间窗: Week 52
Proportion of Participants With Endoscopic Response [Substudy 2]
时间窗: Week 14
Proportion of Participants With Endoscopic Response [Substudy 3]
时间窗: Week 52
Proportion of Participants With Endoscopic Response [Substudy 1]
时间窗: Week 14
Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]
时间窗: Week 14
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
时间窗: Week 14 of SSA
Endoscopic response: SES-CD score \<=4 and at least 2-point reduction from baseline with no subscore \>1 or \>=50% decrease from study baseline in SES-CD. SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers. Ulcerated surface score: 0= none, 1= \<10%, 2= 10% - 30% and 3= \>30%. Affected surface score: 0= unaffected segment, 1= \<50%, 2= 50% - 75%, and 3= \>75%. Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple, can be passed, 3= cannot be passed. Total SES-CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score indicated more severe disease.
Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1
时间窗: Week 14 of SS1
Endoscopic response: SES-CD score \<=4 and at least 2-point reduction from baseline with no subscore \>1 or \>=50% decrease from study baseline in SES-CD. SES-CD consisted of composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers. Ulcerated surface score: 0= none, 1= \<10%, 2= 10% - 30% and 3= \>30%. Affected surface score: 0= unaffected segment, 1= \<50%, 2= 50% - 75%, and 3= \>75%. Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple can be passed, 3= cannot be passed. Total SES CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease. Multiple imputation (MI) method used; percentage calculated based on average response rate from MI datasets.
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort
时间窗: Week 52 of study
Clinical remission was considered as CDAI score \<150. CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); hematocrit (HCT): 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores\*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Non-Responder Cohort
时间窗: Week 52 of study
Clinical remission was considered as CDAI score \<150. CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores\*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Responder Cohort
时间窗: Week 52 of study
Endoscopic response: SES-CD score \<=4 and at least 2-point reduction from baseline with no subscore \>1 or \>=50% decrease from parent study (SS1) baseline in SES-CD. SES-CD consisted of composite score based on size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon; rectum. Size of ulcers score: 0=none, 1=aphthous ulcers,2=large ulcers,3=very large ulcers. Ulcerated surface score: 0= none, 1= \<10%, 2= 10% - 30%, 3= \>30%. Affected surface score: 0= unaffected segment, 1= \<50%,2= 50%-75%,3= \>75%. Presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed,3=cannot be passed. Total SES CD=sum of each domain score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score= more severe disease.
Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Non-Responder Cohort
时间窗: Week 52 of study
Endoscopic response: SES-CD score \<=4 and at least 2-point reduction from baseline with no subscore \>1 or \>=50% decrease from parent study (SS1) baseline in SES-CD. SES-CD consisted of composite score based on size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right, transverse; left colon; rectum. Size of ulcers score: 0=none, 1=aphthous ulcers,2=large ulcers,3=very large ulcers. Ulcerated surface score: 0= none, 1= \<10%, 2= 10% - 30%, 3= \>30%. Affected surface score: 0= unaffected segment, 1= \<50%,2= 50%-75%,3= \>75%. Presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed,3=cannot be passed. Total SES CD=sum of each domain score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score= more severe disease.
次要结局
- Proportion of Participants With Clinical Response CDAI [Substudy 2](Week 14)
- Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3](Week 52)
- Proportion of Participants With Clinical Remission CDAI [Substudy 1](Week 14)
- Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2](Week 14)
- Proportion of Participants With Endoscopic Remission [Substudy 2](Week 14)
- Change from baseline in CD-PRO/SS [Substudy 2](Week 14)
- Proportion of Participants With Endoscopic Remission [Substudy 3](Week 52)
- Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2](Week 14)
- Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4](Up to Week 208)
- Proportion of Participants with Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 1](Week 14)
- Proportion of Participants With Clinical Remission PRO2 [Substudy 3](Week 52)
- Proportion of Participants With Clinical Remission CDAI [Substudy A](Up to Week 66)
- Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A](Baseline to Week 66)
- Proportion of Participants with Clinical Response or Endoscopic Response [Substudy 3](Week 52)
- Change From Baseline in CDAI Score [Substudy A](Baseline to Week 66)
- Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3](Week 52)
- Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3](Week 52)
- Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4](Up to Week 208)
- Number and Severity of Adverse Events(Up to approximately 70 weeks for Substudy A,approximately 24 weeks for Substudy 1 and 2; 42 weeks for Substudy 3; and 212 weeks for Substudy 4)
- Percent Change From Baseline in FCP Concentration at Week 14 in Induction Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA)
- Change From Baseline in FCP Concentration at Week 66 in Extension Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA)
- Percent Change From Baseline in FCP Concentration at Week 66 in Extension Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA)
- Change From Baseline in C-Reactive Protein (CRP) at Week 14 in Induction Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA)
- Percent Change From Baseline in CRP at Week 14 in Induction Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA)
- Change From Baseline in CRP at Week 66 in Extension Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA)
- Percent Change From Baseline in CRP at Week 66 in Extension Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA)
- Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA(Week 14 of SSA)
- Change From Baseline in SES-CD Score at Week 14: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA)
- Change From Baseline in CDAI Score at Week 14: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA)
- Plasma Concentration of Etrasimod at 4 Hours Post-dose: SSA(4 hours post-dose on Day 1)
- Steady State Trough Concentration (Ctrough,ss) of Etrasimod From Week 2 to Week 14: SSA(From Week 2 to Week 14)
- Change From Baseline in Absolute Lymphocyte Count (ALC) at Week 14 in Induction Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA)
- Percent Change From Baseline in ALC at Week 14 in Induction Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA)
- Change From Baseline in ALC at Week 66 in Extension Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA)
- Percent Change From Baseline in ALC at Week 66 in Extension Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA)
- Change From Baseline in Fecal Calprotectin (FCP) Concentration at Week 14 in Induction Period: SSA(Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA)
- Percentage of Participants With Clinical Remission by CDAI at Week 14: SS1(Week 14 of SS1)
- Percentage of Participants With Clinical Remission by Patient Reported Outcomes 2 (PRO2) at Week 14: SS1(Week 14 of SS1)
- Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Non-Responder Cohort(Week 52 of study)
- Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Non-Responder Cohort(Week 52 of study)
- Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Non-Responder Cohort(Week 52 of study)
- Percentage of Participants With Endoscopic Remission at Week 52: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Endoscopic Remission at Week 52: SS3 Non-Responder Cohort(Week 52 of study)
- Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort(Week 52 of study)
- Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Non-Responder Cohort(Week 52 of study)
- Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort(Baseline, study Weeks 20, 28, 36, 44, 52)
- Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort(Baseline, study Weeks 20, 28, 36, 44, 52)
- Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Non-Responder Cohort(Week 52 of study)
- Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Responder Cohort(Baseline, study Weeks 28 and 52)
- Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Non-Responder Cohort(Baseline, study Weeks 28 and 52)
- Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 28 and 52: SS3 Responder Cohort(Baseline, study Weeks 28 and 52)
- Change From Baseline in IBDQ at Weeks 28 and 52: SS3 Non-Responder Cohort(Baseline, study Weeks 28 and 52)
- Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Weeks 28 and 52: SS3 Responder Cohort(Baseline, study Weeks 28 and 52)
- Change From Baseline in SF-36 at Weeks 28 and 52: SS3 Non-Responder Cohort(Baseline, study Weeks 28 and 52)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 28 and 52: SS3 Responder Cohort(Baseline, study Weeks 28 and 52)
- Change From Baseline in FACIT-F at Weeks 28 and 52: SS3 Non-Responder Cohort(Baseline, study Weeks 28 and 52)
- Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at SS3 Baseline: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at Study Entry: SS3 Non-Responder Cohort(Week 52 of study)
- Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort(Baseline, study Weeks 20, 28, 36, 44 and 52)
- Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort(Baseline, study Weeks 20, 28, 36, 44 and 52)
- Time to Remission by PRO2 and FCP Concentrations: SS3 Responder Cohort(From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks))
- Time to Remission by PRO2 and FCP Concentrations: SS3 Non-Responder Cohort(From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks))
- Time to Response by PRO2 and FCP Concentrations: SS3 Responder Cohort(From first maintenance dose in SS3 until date of clinical response and FCP normalization or censoring date (maximum up to 42 weeks))
- Time to Response by PRO2 and FCP Concentrations: SS3 Non-Responder Cohort(From first maintenance dose in SS3 until date of clinical response and FCP normalization or censoring date (maximum up to 42 weeks))
- Change From Baseline in SES-CD Score at Week 52: SS3 Responder Cohort(Baseline and Week 52 of study)
- Change From Baseline in SES-CD Score at Week 52: SS3 Non-Responder Cohort(Baseline and Week 52 of study)
- Percentage of Participants With Endoscopic Response and Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Endoscopic Response and Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort(Week 52 of study)
- Percentage of Participants With Endoscopic Remission and Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort(Week 52 of study)
- Percentage of Participants With Endoscopic Remission and Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort(Week 52 of study)
- Number of Participants According to Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters: SS4(Baseline, Weeks 52, and 104 of SS4)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs by Severity and Treatment Related TEAEs: SS3(From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks))
- Number of Participants With TEAEs of Special Interest: SS3(From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks))
- Number of Participants With Clinically Meaningful Changes in Laboratory Parameters: SS3(From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks))
- Number of Participants With TEAEs, SAEs, TEAEs by Severity and Treatment Related TEAEs: SS4(From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks))
- Number of Participants With TEAEs of Special Interest: SS4(From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks))
- Number of Participants With Clinically Meaningful Changes in Laboratory Parameters: SS4(From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks))
- Number of Participants According to Markedly Abnormal Criteria for Vital Signs: SS4(Baseline, Weeks 1, 12, 24, 36, 52, 64, 76, 88 and 104 of SS4)
- Percentage of Participants With Clinical Remission by CDAI at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4(Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4)
- Percentage of Participants With Clinical Response by CDAI at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4(Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4)
- Percentage of Participants With Clinical Remission by PRO2 at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4(Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4)