Trial Outcomes & Findings for A Study of E6011 in Participants With Active Crohn's Disease (NCT NCT03733314)

Last Updated: 2025-04-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

At Week 12

Results posted on

2025-04-02

Participant Flow

Participants took part in the study at 49 investigative sites in Japan, Czech Republic, Hungary, Poland, and Russia from 25 April 2019 to 03 April 2024.

A total of 65 participants were screened, of which 40 were screen failures and 25 were enrolled to receive study treatment.

Participant milestones

Participant milestones
Measure	E6011 10 mg/kg Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Remission-induction Period: (Weeks 0-12) STARTED	12	13
Remission-induction Period: (Weeks 0-12) CDAI Responders at Week 12	5	6
Remission-induction Period: (Weeks 0-12) CDAI Non-responders at Week 12	5	7
Remission-induction Period: (Weeks 0-12) COMPLETED	10	13
Remission-induction Period: (Weeks 0-12) NOT COMPLETED	2	0
Rescue Period: (Weeks 12 to 24) STARTED	5	7
Rescue Period: (Weeks 12 to 24) CDAI Responders at Week 24	2	2
Rescue Period: (Weeks 12 to 24) CDAI Non-responders at Week 24	2	1
Rescue Period: (Weeks 12 to 24) COMPLETED	4	3
Rescue Period: (Weeks 12 to 24) NOT COMPLETED	1	4
Extension Period:(Week 12-52/Week 24-64) STARTED	7	8
Extension Period:(Week 12-52/Week 24-64) COMPLETED	2	5
Extension Period:(Week 12-52/Week 24-64) NOT COMPLETED	5	3
Post-observation Period STARTED	12	13
Post-observation Period COMPLETED	12	13
Post-observation Period NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	E6011 10 mg/kg Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Remission-induction Period: (Weeks 0-12) Withdrawal by Subject	2	0
Rescue Period: (Weeks 12 to 24) Withdrawal by Subject	1	2
Rescue Period: (Weeks 12 to 24) Progressive disease	0	2
Extension Period:(Week 12-52/Week 24-64) Lack of Efficacy	1	1
Extension Period:(Week 12-52/Week 24-64) Progressive Disease	1	0
Extension Period:(Week 12-52/Week 24-64) Other	3	2

Baseline Characteristics

A Study of E6011 in Participants With Active Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Total n=25 Participants Total of all reporting groups
Age, Continuous	29.8 years STANDARD_DEVIATION 8.7 • n=99 Participants	33.2 years STANDARD_DEVIATION 12.0 • n=107 Participants	31.5 years STANDARD_DEVIATION 10.5 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	8 Participants n=107 Participants	18 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=99 Participants	13 Participants n=107 Participants	25 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	11 Participants n=99 Participants	9 Participants n=107 Participants	20 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: At Week 12

Population: 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).

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12	33.3 percentage of participants Interval 9.9 to 65.1	23.1 percentage of participants Interval 5.0 to 53.8

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Population: 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.

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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants With CR70 and CR100 CR70: Week 56	—	100.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 12	50.0 percentage of participants	46.2 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 14	25.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 16	70.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 20	66.7 percentage of participants	62.5 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 24	62.5 percentage of participants	71.4 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 28	100.0 percentage of participants	85.7 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 32	50.0 percentage of participants	83.3 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 36	100.0 percentage of participants	83.3 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 40	100.0 percentage of participants	75.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 44	100.0 percentage of participants	80.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 52	66.7 percentage of participants	66.7 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 60	—	100.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 48	66.7 percentage of participants	100.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 2	16.7 percentage of participants	15.4 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 4	18.2 percentage of participants	23.1 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 8	30.0 percentage of participants	30.8 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 12	40.0 percentage of participants	23.1 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 28	100.0 percentage of participants	71.4 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 32	50.0 percentage of participants	83.3 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 36	75.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 40	100.0 percentage of participants	75.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 44	66.7 percentage of participants	80.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 48	66.7 percentage of participants	75.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 14	25.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 16	70.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 20	55.6 percentage of participants	50.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 24	50.0 percentage of participants	57.1 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 64	—	100.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 52	66.7 percentage of participants	66.7 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 56	—	100.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 60	—	50.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR100: Week 64	—	100.0 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 2	16.7 percentage of participants	23.1 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 4	45.5 percentage of participants	23.1 percentage of participants
Percentage of Participants With CR70 and CR100 CR70: Week 8	50.0 percentage of participants	38.5 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Population: 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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 48	0.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 56	—	100.0 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 64	—	100.0 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 8	20.0 percentage of participants	30.8 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 12	10.0 percentage of participants	15.4 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 14	0.0 percentage of participants	16.7 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 44	33.3 percentage of participants	60.0 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 16	20.0 percentage of participants	30.0 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 20	11.1 percentage of participants	37.5 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 24	12.5 percentage of participants	42.9 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 28	100.0 percentage of participants	42.9 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 32	50.0 percentage of participants	83.3 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 36	25.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 40	66.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 2	0.0 percentage of participants	7.7 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 4	0.0 percentage of participants	15.4 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 52	33.3 percentage of participants	66.7 percentage of participants
Percentage of Participants With Below 150 CDAI Points CDAI <150 points: Week 60	—	50.0 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Population: 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.

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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 8	60.0 percentage of participants	53.8 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 14	25.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 16	70.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 36	75.0 percentage of participants	83.3 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 40	100.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 2	16.7 percentage of participants	15.4 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 48	100.0 percentage of participants	75.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 28	100.0 percentage of participants	85.7 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 4	45.5 percentage of participants	38.5 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 20	77.8 percentage of participants	75.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 24	62.5 percentage of participants	71.4 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 32	50.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 44	100.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 48	100.0 percentage of participants	75.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 52	100.0 percentage of participants	66.7 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 56	—	100.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 60	—	100.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 64	—	100.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 4	27.3 percentage of participants	30.8 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 8	40.0 percentage of participants	30.8 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 12	40.0 percentage of participants	30.8 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 14	25.0 percentage of participants	16.7 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 16	60.0 percentage of participants	40.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 20	55.6 percentage of participants	62.5 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 24	50.0 percentage of participants	57.1 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 28	100.0 percentage of participants	57.1 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 32	50.0 percentage of participants	66.7 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 36	75.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 40	100.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 44	100.0 percentage of participants	60.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 52	66.7 percentage of participants	66.7 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 56	—	100.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 60	—	50.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=8-point reduction: Week 64	—	100.0 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 12	50.0 percentage of participants	53.8 percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) >=5-point reduction: Week 2	25.0 percentage of participants	38.5 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 2	8.3 percentage of participants	7.7 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 12	10.0 percentage of participants	15.4 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 4	9.1 percentage of participants	7.7 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 8	20.0 percentage of participants	23.1 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 14	0.0 percentage of participants	16.7 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 16	10.0 percentage of participants	30.0 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 20	0.0 percentage of participants	37.5 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 24	12.5 percentage of participants	28.6 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 28	25.0 percentage of participants	14.3 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 32	25.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 36	0.0 percentage of participants	16.7 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 40	33.3 percentage of participants	25.0 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 44	0.0 percentage of participants	40.0 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 48	0.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 52	33.3 percentage of participants	66.7 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 56	—	100.0 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 60	—	50.0 percentage of participants
Percentage of Participants With Below 8 Points in PRO2 PRO2 <8 points: Week 64	—	100.0 percentage of participants

SECONDARY outcome

Timeframe: At Week 12

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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants With at Least 50 Percent (%) Improvement in (Endoscopic Response) Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 12	8.3 percentage of participants Interval 0.2 to 38.5	15.4 percentage of participants Interval 1.9 to 45.4

SECONDARY outcome

Timeframe: At Week 12

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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants With Less Than or Equal to (<=) 2 (Endoscopic Remission) SES-CD Score at Week 12	8.3 percentage of participants Interval 0.2 to 38.5	0.0 percentage of participants Interval 0.0 to 24.7

SECONDARY outcome

Timeframe: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Population: 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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Change From Baseline in CDAI Score Change at Week 28	-160.7 score on a scale Standard Deviation 28.1	-153.1 score on a scale Standard Deviation 93.5
Change From Baseline in CDAI Score Change at Week 44	-147.3 score on a scale Standard Deviation 75.8	-185.2 score on a scale Standard Deviation 102.9
Change From Baseline in CDAI Score Change at Week 2	-38.0 score on a scale Standard Deviation 96.1	-50.3 score on a scale Standard Deviation 56.7
Change From Baseline in CDAI Score Change at Week 4	-60.5 score on a scale Standard Deviation 102.7	-64.5 score on a scale Standard Deviation 91.0
Change From Baseline in CDAI Score Change at Week 8	-92.8 score on a scale Standard Deviation 109.8	-70.5 score on a scale Standard Deviation 113.3
Change From Baseline in CDAI Score Change at Week 12	-92.4 score on a scale Standard Deviation 109.0	-69.6 score on a scale Standard Deviation 107.0
Change From Baseline in CDAI Score Change at Week 14	-22.0 score on a scale Standard Deviation 78.1	-25.8 score on a scale Standard Deviation 100.8
Change From Baseline in CDAI Score Change at Week 16	-102.8 score on a scale Standard Deviation 95.2	-89.3 score on a scale Standard Deviation 120.1
Change From Baseline in CDAI Score Change at Week 20	-115.4 score on a scale Standard Deviation 66.1	-119.1 score on a scale Standard Deviation 136.4
Change From Baseline in CDAI Score Change at Week 24	-115.5 score on a scale Standard Deviation 90.1	-100.0 score on a scale Standard Deviation 120.3
Change From Baseline in CDAI Score Change at Week 32	-97.3 score on a scale Standard Deviation 95.1	-183.7 score on a scale Standard Deviation 79.1
Change From Baseline in CDAI Score Change at Week 36	-136.0 score on a scale Standard Deviation 44.2	-143.0 score on a scale Standard Deviation 109.8
Change From Baseline in CDAI Score Change at Week 40	-173.7 score on a scale Standard Deviation 49.0	-157.0 score on a scale Standard Deviation 84.0
Change From Baseline in CDAI Score Change at Week 48	-127.3 score on a scale Standard Deviation 56.1	-209.8 score on a scale Standard Deviation 99.2
Change From Baseline in CDAI Score Change at Week 52	-103.7 score on a scale Standard Deviation 102.8	-171.3 score on a scale Standard Deviation 162.4
Change From Baseline in CDAI Score Change at Week 56	—	-211.0 score on a scale Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in CDAI Score Change at Week 60	—	-145.0 score on a scale Standard Deviation 97.6
Change From Baseline in CDAI Score Change at Week 64	—	-240.0 score on a scale Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.

SECONDARY outcome

Timeframe: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percent Change From Baseline in CDAI Score Percent Change at Week 16	-29.3 percent change Standard Deviation 23.6	-27.5 percent change Standard Deviation 37.0
Percent Change From Baseline in CDAI Score Percent Change at Week 44	-45.7 percent change Standard Deviation 23.1	-56.8 percent change Standard Deviation 27.1
Percent Change From Baseline in CDAI Score Percent Change at Week 2	-8.9 percent change Standard Deviation 24.6	-16.7 percent change Standard Deviation 21.1
Percent Change From Baseline in CDAI Score Percent Change at Week 4	-16.0 percent change Standard Deviation 26.1	-20.6 percent change Standard Deviation 26.6
Percent Change From Baseline in CDAI Score Percent Change at Week 8	-25.8 percent change Standard Deviation 27.7	-23.1 percent change Standard Deviation 37.1
Percent Change From Baseline in CDAI Score Percent Change at Week 12	-25.3 percent change Standard Deviation 27.1	-21.8 percent change Standard Deviation 33.9
Percent Change From Baseline in CDAI Score Percent Change at Week 14	-8.3 percent change Standard Deviation 28.4	-9.3 percent change Standard Deviation 36.6
Percent Change From Baseline in CDAI Score Percent Change at Week 20	-34.5 percent change Standard Deviation 17.5	-36.6 percent change Standard Deviation 45.4
Percent Change From Baseline in CDAI Score Percent Change at Week 24	-34.8 percent change Standard Deviation 25.3	-32.6 percent change Standard Deviation 44.1
Percent Change From Baseline in CDAI Score Percent Change at Week 28	-53.6 percent change Standard Deviation 3.4	-48.3 percent change Standard Deviation 26.2
Percent Change From Baseline in CDAI Score Percent Change at Week 32	-31.4 percent change Standard Deviation 29.3	-60.1 percent change Standard Deviation 28.3
Percent Change From Baseline in CDAI Score Percent Change at Week 36	-43.3 percent change Standard Deviation 10.3	-43.5 percent change Standard Deviation 30.2
Percent Change From Baseline in CDAI Score Percent Change at Week 40	-53.9 percent change Standard Deviation 15.7	-50.2 percent change Standard Deviation 23.7
Percent Change From Baseline in CDAI Score Percent Change at Week 48	-39.6 percent change Standard Deviation 17.8	-63.7 percent change Standard Deviation 25.5
Percent Change From Baseline in CDAI Score Percent Change at Week 52	-33.0 percent change Standard Deviation 32.4	-53.8 percent change Standard Deviation 48.2
Percent Change From Baseline in CDAI Score Percent Change at Week 56	—	-77.0 percent change Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Percent Change From Baseline in CDAI Score Percent Change at Week 60	—	-51.9 percent change Standard Deviation 37.1
Percent Change From Baseline in CDAI Score Percent Change at Week 64	—	-87.6 percent change Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.

SECONDARY outcome

Timeframe: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Change From Baseline in PRO2 Change at Week 2	-3.1 score on a scale Standard Deviation 6.5	-4.3 score on a scale Standard Deviation 4.0
Change From Baseline in PRO2 Change at Week 4	-5.3 score on a scale Standard Deviation 6.6	-4.9 score on a scale Standard Deviation 6.5
Change From Baseline in PRO2 Change at Week 8	-6.9 score on a scale Standard Deviation 7.3	-5.8 score on a scale Standard Deviation 7.1
Change From Baseline in PRO2 Change at Week 12	-6.5 score on a scale Standard Deviation 6.2	-5.5 score on a scale Standard Deviation 6.7
Change From Baseline in PRO2 Change at Week 14	-3.0 score on a scale Standard Deviation 6.7	-2.7 score on a scale Standard Deviation 5.4
Change From Baseline in PRO2 Change at Week 16	-8.1 score on a scale Standard Deviation 5.7	-6.1 score on a scale Standard Deviation 7.6
Change From Baseline in PRO2 Change at Week 20	-7.9 score on a scale Standard Deviation 4.2	-8.3 score on a scale Standard Deviation 9.2
Change From Baseline in PRO2 Change at Week 24	-6.5 score on a scale Standard Deviation 6.4	-6.9 score on a scale Standard Deviation 7.4
Change From Baseline in PRO2 Change at Week 28	-9.0 score on a scale Standard Deviation 1.0	-9.6 score on a scale Standard Deviation 5.7
Change From Baseline in PRO2 Change at Week 32	-5.5 score on a scale Standard Deviation 6.1	-12.0 score on a scale Standard Deviation 6.2
Change From Baseline in PRO2 Change at Week 36	-9.0 score on a scale Standard Deviation 7.0	-9.0 score on a scale Standard Deviation 6.1
Change From Baseline in PRO2 Change at Week 40	-13.0 score on a scale Standard Deviation 1.7	-6.3 score on a scale Standard Deviation 6.8
Change From Baseline in PRO2 Change at Week 44	-11.0 score on a scale Standard Deviation 2.0	-9.4 score on a scale Standard Deviation 7.7
Change From Baseline in PRO2 Change at Week 48	-8.7 score on a scale Standard Deviation 0.6	-11.8 score on a scale Standard Deviation 6.6
Change From Baseline in PRO2 Change at Week 52	-8.3 score on a scale Standard Deviation 3.1	-11.0 score on a scale Standard Deviation 8.5
Change From Baseline in PRO2 Change at Week 56	—	-13.0 score on a scale Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in PRO2 Change at Week 60	—	-9.5 score on a scale Standard Deviation 6.4
Change From Baseline in PRO2 Change at Week 64	—	-15.0 score on a scale Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=12 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percent Change From Baseline in PRO2 Percent Change at Week 14	-13.4 percent change Standard Deviation 28.6	-17.6 percent change Standard Deviation 32.7
Percent Change From Baseline in PRO2 Percent Change at Week 16	-36.8 percent change Standard Deviation 25.0	-27.9 percent change Standard Deviation 34.4
Percent Change From Baseline in PRO2 Percent Change at Week 2	-13.5 percent change Standard Deviation 31.3	-20.9 percent change Standard Deviation 20.0
Percent Change From Baseline in PRO2 Percent Change at Week 4	-23.0 percent change Standard Deviation 29.8	-22.9 percent change Standard Deviation 28.4
Percent Change From Baseline in PRO2 Percent Change at Week 8	-30.1 percent change Standard Deviation 33.0	-29.2 percent change Standard Deviation 34.6
Percent Change From Baseline in PRO2 Percent Change at Week 12	-29.4 percent change Standard Deviation 28.0	-25.8 percent change Standard Deviation 31.0
Percent Change From Baseline in PRO2 Percent Change at Week 20	-36.2 percent change Standard Deviation 16.8	-37.6 percent change Standard Deviation 46.7
Percent Change From Baseline in PRO2 Percent Change at Week 24	-30.0 percent change Standard Deviation 28.0	-35.9 percent change Standard Deviation 41.1
Percent Change From Baseline in PRO2 Percent Change at Week 28	-47.7 percent change Standard Deviation 9.2	-46.2 percent change Standard Deviation 23.7
Percent Change From Baseline in PRO2 Percent Change at Week 32	-25.1 percent change Standard Deviation 32.7	-58.3 percent change Standard Deviation 30.3
Percent Change From Baseline in PRO2 Percent Change at Week 36	-37.1 percent change Standard Deviation 25.5	-42.9 percent change Standard Deviation 24.6
Percent Change From Baseline in PRO2 Percent Change at Week 40	-56.4 percent change Standard Deviation 14.3	-31.2 percent change Standard Deviation 32.6
Percent Change From Baseline in PRO2 Percent Change at Week 44	-46.9 percent change Standard Deviation 9.1	-45.3 percent change Standard Deviation 32.5
Percent Change From Baseline in PRO2 Percent Change at Week 48	-37.3 percent change Standard Deviation 7.2	-57.2 percent change Standard Deviation 26.7
Percent Change From Baseline in PRO2 Percent Change at Week 52	-38.4 percent change Standard Deviation 22.2	-56.1 percent change Standard Deviation 34.6
Percent Change From Baseline in PRO2 Percent Change at Week 56	—	-81.3 percent change Standard Deviation NA Standard deviation could not be estimated due to insufficient number of participants.
Percent Change From Baseline in PRO2 Percent Change at Week 60	—	-59.4 percent change Standard Deviation 39.8
Percent Change From Baseline in PRO2 Percent Change at Week 64	—	-93.8 percent change Standard Deviation NA Standard deviation could not be estimated due to insufficient number of participants.

SECONDARY outcome

Timeframe: Baseline, at Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=10 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Change From Baseline in SES-CD Score at Week 12	1.4 score on a scale Standard Deviation 4.9	-3.5 score on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: Baseline, at Week 12

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

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=10 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=13 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percent Change From Baseline in SES-CD Score at Week 12	-0.3 percent change Standard Deviation 45.6	-19.2 percent change Standard Deviation 33.2

SECONDARY outcome

Timeframe: Up to Week 64

Population: 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 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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=3 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=6 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants Who Achieved Steroid-free Remission up to Week 64	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 64

Population: 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.

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.

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=3 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=6 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percentage of Participants Who Achieved Steroid-free Improvement up to Week 64	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 64

Population: 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.

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

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=3 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=6 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64	0 milligram per day (mg/day) Standard Deviation 0	0 milligram per day (mg/day) Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline up to Week 64

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

Outcome measures

Outcome measures
Measure	E6011 10 mg/kg n=3 Participants Participants with moderate to severe active Crohn's disease received E6011 10 milligram per kilogram (mg/kg), intravenous (IV) infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants continued E6011 treatment at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.	Placebo Then E6011 10 mg/kg n=6 Participants Participants with moderate to severe active Crohn's disease received placebo, IV infusion once, at Weeks 0, 1, 2 then every 2 weeks up Week 10 during the Remission Induction Period, thereafter, non-responder participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during the Rescue Period. Responder participants at Week 12 continued E6011 treatment, every 4 weeks from Week 12 to Week 48 and responders at Week 24 continued E6011 treatment, every 4 weeks, from Week 24 to Week 60 during the Extension Period.
Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64	0 percent change Standard Deviation 0	0 percent change Standard Deviation 0

Adverse Events

Remission Induction Period: E6011 10 mg/kg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Remission Induction Period: Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Rescue Period: E6011 10 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Rescue Period: Placebo to E6011 10 mg/kg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Extension Period: E6011 10 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Extension Period: Placebo to E6011 10 mg/kg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Post-observation Period: E6011 10 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Post-observation Period: Placebo to E6011 10 mg/kg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Remission Induction Period: E6011 10 mg/kg n=12 participants at risk Participants received E6011 10 mg/kg, IV infusion once, at Weeks 0,1, 2 then every 2 weeks up Week 10 during Remission Induction Period.	Remission Induction Period: Placebo n=13 participants at risk Participants received placebo, IV infusion once, at Weeks 0,1, 2 then every 2 weeks up Week 10 during Remission Induction Period.	Rescue Period: E6011 10 mg/kg n=5 participants at risk Participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during Rescue Period.	Rescue Period: Placebo to E6011 10 mg/kg n=7 participants at risk Participants who received placebo in the remission induction period received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during Rescue the Period.	Extension Period: E6011 10 mg/kg n=7 participants at risk Participants with response at Week 12 and Week 24 received E6011 10 mg/kg, IV infusion once, every 4 weeks from Week 12 to Week 48 and Week 24 to Week 60, respectively, during the Extension Period.	Extension Period: Placebo to E6011 10 mg/kg n=8 participants at risk Participants who received placebo in the remission induction period, who had response at Week 12 and Week 24 received E6011 10 mg/kg, IV infusion once, every 4 weeks from Week 12 to Week 48 and Week 24 to Week 60, respectively during the Extension Period.	Post-observation Period: E6011 10 mg/kg n=12 participants at risk Participants who received E6011 10 mg/kg in any of the treatment periods were observed during Post-observation Period for 70 days after last dose.	Post-observation Period: Placebo to E6011 10 mg/kg n=13 participants at risk Participants who received placebo in the remission induction period and who were switched to receive E6011 10 mg/kg in Rescue or Extension periods were observed during Post-observation Period for 70 days after last dose.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Gastrointestinal disorders Crohn's Disease	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	14.3% 1/7 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	14.3% 1/7 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug

Other adverse events

Other adverse events
Measure	Remission Induction Period: E6011 10 mg/kg n=12 participants at risk Participants received E6011 10 mg/kg, IV infusion once, at Weeks 0,1, 2 then every 2 weeks up Week 10 during Remission Induction Period.	Remission Induction Period: Placebo n=13 participants at risk Participants received placebo, IV infusion once, at Weeks 0,1, 2 then every 2 weeks up Week 10 during Remission Induction Period.	Rescue Period: E6011 10 mg/kg n=5 participants at risk Participants received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during Rescue Period.	Rescue Period: Placebo to E6011 10 mg/kg n=7 participants at risk Participants who received placebo in the remission induction period received E6011 10 mg/kg, IV infusion once, at Weeks 12, 13, 14 then every 2 weeks up to Week 22 during Rescue the Period.	Extension Period: E6011 10 mg/kg n=7 participants at risk Participants with response at Week 12 and Week 24 received E6011 10 mg/kg, IV infusion once, every 4 weeks from Week 12 to Week 48 and Week 24 to Week 60, respectively, during the Extension Period.	Extension Period: Placebo to E6011 10 mg/kg n=8 participants at risk Participants who received placebo in the remission induction period, who had response at Week 12 and Week 24 received E6011 10 mg/kg, IV infusion once, every 4 weeks from Week 12 to Week 48 and Week 24 to Week 60, respectively during the Extension Period.	Post-observation Period: E6011 10 mg/kg n=12 participants at risk Participants who received E6011 10 mg/kg in any of the treatment periods were observed during Post-observation Period for 70 days after last dose.	Post-observation Period: Placebo to E6011 10 mg/kg n=13 participants at risk Participants who received placebo in the remission induction period and who were switched to receive E6011 10 mg/kg in Rescue or Extension periods were observed during Post-observation Period for 70 days after last dose.
Infections and infestations Covid-19	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	14.3% 1/7 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	14.3% 1/7 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 3 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Infections and infestations Conjunctivitis	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Infections and infestations Respiratory Tract Infection	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Blood and lymphatic system disorders Anaemia	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 2 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Nervous system disorders Facial Paralysis	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Nervous system disorders Migraine	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Gastrointestinal disorders Abdominal Pain Upper	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Gastrointestinal disorders Toothache	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Gastrointestinal disorders Crohn's Disease	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Gastrointestinal disorders Haemorrhoids	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Gastrointestinal disorders Stomatitis	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Musculoskeletal and connective tissue disorders Temporomandibular Joint Syndrome	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	7.7% 1/13 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	20.0% 1/5 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
General disorders Pyrexia	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	20.0% 1/5 • Number of events 2 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	28.6% 2/7 • Number of events 2 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Renal and urinary disorders Dysuria	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	20.0% 1/5 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	20.0% 1/5 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Investigations Weight Decreased	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	14.3% 1/7 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Immune system disorders Immunisation Reaction	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	14.3% 1/7 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/8 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	8.3% 1/12 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Cardiac disorders Atrioventricular Block First Degree	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Cardiac disorders Cardiomyopathy	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug
Injury, poisoning and procedural complications Compression Fracture	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/5 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/7 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	12.5% 1/8 • Number of events 1 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/12 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug	0.00% 0/13 • Remission induction period: From the first dose of the study drug (Week 0) up to Week 12; Rescue period: From Week 12 up to Week 24; Extension period: Week 12 up to Week 64; Post-observation period: Up to 70 days after last dose of study drug

Additional Information

Corporate Communication Dept.

EA Pharma Co., Ltd

Phone: +81-(0)3-6280-9600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place