CR100 was defined as clinical response with a reduction of greater than or equal to (>=) 100 points in CDAI score from baseline. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

The FAS included participants to whom the IMP has been administered after randomization, and who had 1 or more evaluable, post-IMP administration primary efficacy endpoint (that is, to have an evaluable (CDAI) value at baseline and any other post baseline).

CR70 was defined as CR with a reduction of >=70 points in CDAI score from baseline. CR100 was defined as clinical response with a reduction of >=100 points in CDAI score from baseline. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

FAS was used for analysis. Here "number analyzed" ('n') = participants who were evaluable for outcome measure at given time points. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. From Week 14-24, participants data analyzed simultaneously for rescue and extension period and reported collectively.

CDAI remission was defined as CDAI score below (<) 150 points. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

FAS was used for analysis. Here, number analyzed "n"= participants who were evaluable for outcome measure at given time points. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. From Week 14-24, participants data analyzed simultaneously for rescue and extension period and reported collectively.

Patient reported outcome 2-clinical response 5 (PRO2-CR5) was defined as CR with a reduction of 5 or more points in PRO2 score from baseline. Patient reported outcome 2-clinical response 8 (PRO2-CR8) was defined as CR with a reduction of 8 or more points in PRO2 score from baseline. The PRO2 scale is a patient-reported outcome measure specifically used to assess the severity of Crohn's disease. It is derived from the CDAI and focuses on two main symptoms: abdominal pain and stool frequency. Participants rate their abdominal pain on a scale from 0 (none) to 3 (severe) and report the number of soft or liquid stools they have per day, which are then multiplied by a factor of 2 and 5, respectively. The scores from these two components are combined to give an overall PRO2 score ranging from 0 to no upper limit, with a higher score=worse outcome.

FAS was used for analysis. Here, "n" = participants who were evaluable for outcome measure at given time points. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. From Week 14-24, participants data analyzed simultaneously for rescue and extension period and reported collectively.

The PRO2 scale is a patient-reported outcome measure specifically used to assess the severity of Crohn's disease. It is derived from the CDAI and focuses on two main symptoms: abdominal pain and stool frequency. Participants rate their abdominal pain on a scale from 0 (none) to 3 (severe) and report the number of soft or liquid stools they have per day, which are then multiplied by a factor of 2 and 5, respectively. The scores from these two components are combined to give an overall PRO2 score ranging from 0 to no upper limit, with a higher score=worse outcome.

FAS was used for analysis. Here, "n" = participants who were evaluable for outcome measure at given time points. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. From Week 14-24, participants data analyzed simultaneously for rescue and extension period and reported collectively.

Endoscopic response was defined as a improvement in SES-CD of at least 50% from baseline. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: terminal ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease.

The FAS included participants to whom the IMP has been administered after randomization, and who had 1 or more evaluable, post-IMP administration primary efficacy endpoint (that is, to have an evaluable (CDAI) value at baseline and any other post baseline).

Endoscopic remission was defined as 2 or less points on SES-CD. The SES-CD assesses following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on scale of 0 (none/unaffected) to 3 (worst). In SES-CD, each of these 4 components are assessed in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease.

The FAS included participants to whom the IMP has been administered after randomization, and who had 1 or more evaluable, post-IMP administration primary efficacy endpoint (that is, to have an evaluable (CDAI) value at baseline and any other post baseline).

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

FAS was used for analysis. Here "n" = participants who were evaluable for outcome measure at given time points. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. From Week 14-24, participants data analyzed simultaneously for rescue and extension period and reported collectively.

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

FAS was used for analysis. Here "n" = participants who were evaluable for outcome measure at given time points. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. From Week 14-24, participants data analyzed simultaneously for rescue and extension period and reported collectively.

The PRO2 scale is a patient-reported outcome measure specifically used to assess the severity of Crohn's disease. It is derived from the CDAI and focuses on two main symptoms: abdominal pain and stool frequency. Participants rate their abdominal pain on a scale from 0 (none) to 3 (severe) and report the number of soft or liquid stools they have per day, which are then multiplied by a factor of 2 and 5, respectively. The scores from these two components are combined to give an overall PRO2 score ranging from 0 to no upper limit, with a higher score=worse outcome.

FAS was used for analysis. Here "n" = participants who were evaluable for outcome measure at given time points. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. From Week 14-24, participants data analyzed simultaneously for rescue and extension period and reported collectively.

The PRO2 scale is a patient-reported outcome measure specifically used to assess the severity of Crohn's disease. It is derived from the CDAI and focuses on two main symptoms: abdominal pain and stool frequency. Participants rate their abdominal pain on a scale from 0 (none) to 3 (severe) and report the number of soft or liquid stools they have per day, which are then multiplied by a factor of 2 and 5, respectively. The scores from these two components are combined to give an overall PRO2 score ranging from 0 to no upper limit, with a higher score=worse outcome.

FAS was used for analysis. Here "n" = participants who were evaluable for outcome measure at given time points. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. From Week 14-24, participants data analyzed simultaneously for rescue and extension period and reported collectively.

The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: terminal ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease.

FAS was used for analysis. Here, "overall number of participants analyzed" ('N') = participants who were evaluable for this outcome measure.

The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: terminal ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease.

FAS was used for analysis. Here "overall number of participants analyzed" ('N') = participants who were evaluable for this outcome measure.

Steroid-free remission was defined as clinical remission (CDAI remission or PRO2-remission) in participants who became steroid free through steroid reduction. CDAI remission was defined as CDAI score below 150 points. PRO2-remission was defined as PRO2- score less than 8-points. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. The total CDAI score ranged from 0-600 with a higher score indicating a worse outcome. Participants for PRO2 scale rate their abdominal pain on scale from 0 (none) to 3 (severe) and report the number of soft or liquid stools they have per day, which are then multiplied by a factor of 2 and 5, respectively. Scores from two components combined to give overall score ranging from 0 to no upper limit, with higher score=worse outcome.

FAS was used for analysis. Here, "overall number of participants analyzed" ('N') = participants who were evaluable for this outcome measure. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. Steroid-free remission was assessed in participants who were concomitantly taking adrenocorticosteroid.

Steroid-free clinical improvement = clinical response (CR70 response, CR100 response, PRO2-CR5 and PRO2-CR8 responses) in participants who became steroid free through steroid reduction. CR70 and CR100 = clinical response with decrease of >=70 point and >=100 point from baseline, respectively in CDAI. PRO2-CR5 and PRO2-CR8 = clinical response with decrease of >=5 point and >=8 point from baseline, respectively in PRO2. CDAI system was composite index of 8 disease activity variables. Total CDAI score ranged 0-600; higher score = worse outcome. Participants for PRO2 scale rate their abdominal pain on scale from 0 (none) to 3 (severe); report number of soft or liquid stools they have per day, which are multiplied by factor of 2 and 5, respectively. The scores from these two components are combined to give an overall PRO2 score ranging from 0 to no upper limit, with a higher score=worse outcome.

FAS was used for analysis. Here, "overall number of participants analyzed" ('N') = participants who were evaluable for this outcome measure. As planned, combined data for all the periods (remission-induction, rescue and extension periods) was collected and reported in outcome measure due to same dosing of E6011. Steroid-free improvement was assessed in participants who were concomitantly taking adrenocorticosteroid.

Change from baseline in steroid dosage in participants concomitantly using adrenocorticosteroids up to Week 64 was reported.

FAS was used for analysis. Here, "N" = participants who were evaluable for this outcome measure. As planned, combined data for all the periods (remission-induction, rescue, extension and post observation periods) was collected and reported in outcome measure due to same dosing of E6011.

Percent change from baseline in steroid dosage in participants concomitantly using adrenocorticosteroids up to Week 64 was reported.

FAS was used for analysis. Here, "N" = participants who were evaluable for this outcome measure. As planned, combined data for all the periods (remission-induction, rescue, extension and post observation periods) was collected and reported in outcome measure due to same dosing of E6011.