ClinicalTrials.gg
Sign In
CompletedNCT03733314Updated Apr 2, 2025Results posted

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

A Phase 2 interventional study of E6011 and Placebo in Crohn's Disease, sponsored by EA Pharma Co., Ltd.. Completed at 46 sites in 5 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by EA Pharma Co., Ltd. (part of Eisai Co., Ltd.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

The primary purpose of this study is to examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial.

Read the detailed description

Participants with moderate to severe Crohn's disease will be enrolled in this study.

The study will include screening period, remission-induction period (double-blind), rescue period (open-label), extension period (open-label), post-observation period, and a follow-up period.

At the end of remission-induction period, participants with reduction in Crohn's disease activity index (CDAI) score of 70 points or more when compared to baseline will move on to the open-label extension period, and participants with less than 70 points reduction in CDAI score will move on to the rescue period. At the end of the rescue period, participants with a reduction in the CDAI of 70 points or more will move on to the open-label extension period and with less than 70 points reduction in the CDAI score will be discontinued.

The post-observation period will include in-person assessment after the completion or discontinuation of the extension period, and participants will be contacted by telephone, etc. after the last dose of study drug administration. Participants will be contacted over phone after the last dose of study drug administration for follow up assessments.

02

Conditions studied

  • Crohn's Disease

Keywords

  • Crohn's Disease
  • E6011
  • Inflammatory Bowel Diseases
  • Gastroenteritis
  • Gastrointestinal tract
03

In context

Crohn Disease

1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.

This study's enrollment of 25 is below the median of 67 across 1,260 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

EA Pharma Co., Ltd. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Browse EA Pharma Co., Ltd. studies →All Eisai Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Has diagnosed on basis of clinical findings, endoscopic findings, etc. with small intestine-type, small and large-intestine type, or large-intestine type Crohn's disease at least 12 weeks before giving consent.
  2. With a baseline (at week 0 before the start of medicinal product [IMP] administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and 34.
  3. With a SES-CD >=7 (or for participants with isolated ileal disease, >=4 in ileum segment) in the screening period, with one or more ulcers (in SES-CD score, ulcer presence subscore >=1 in any segment) assessed by colonoscopy and confirmed by a centralised review.
  4. Who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient response) or the drugs were not tolerated (intolerance). Alternatively, participants who cannot taper adrenocorticosteroids (dependence). Alternatively, participants who showed no therapeutic response after administering biologic(s) (primary nonresponse), participants who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or participants who did not tolerate the drug (intolerance).
  5. If the participants are taking aminosalicylic acid (5-ASA), salazosulfapyridine, or antibiotics for the treatment of Crohn's disease (metronidazole, ciprofloxacin, etc.), the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
  6. If the participants are taking under 30 milligram per day (mg/day) of oral prednisolone (or equivalent adrenocorticosteroid) or 9 mg/day or less of oral budesonide, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
  7. If the participants are taking azathioprine (AZP), 6-mercaptopurine (6-MP) or methotrexate (MTX), the dosage and administration have not changed for at least 8 weeks prior to the start of the IMP administration.

Exclusion criteria

Exclusion Criteria:

  1. Diagnosed with ulcerative colitis or indeterminate colitis.
  2. Diagnosed with gastrointestinal epithelial dysplasia.
  3. Who have an abscess or are suspected to have one.
  4. With an artificial anus, ileo-anal pouch or fistula.
  5. With symptomatic or high-grade gastrointestinal stenosis (participants who require expansion by endoscopy or who require have SES-CD score stenosis sub-score of 3, etc.).
  6. Who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    E6011

    Drug: E6011

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugE6011

    E6011, infusion, intravenously.

  • DrugPlacebo

    Placebo, infusion, intravenously.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12

    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.

    Time frame: At Week 12

Secondary outcomes

  1. Percentage of Participants With CR70 and CR100

    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.

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

  2. Percentage of Participants With Below 150 CDAI Points

    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.

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

  3. Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)

    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.

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

  4. Percentage of Participants With Below 8 Points in PRO2

    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.

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

  5. 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

    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.

    Time frame: At Week 12

  6. Percentage of Participants With Less Than or Equal to (<=) 2 (Endoscopic Remission) SES-CD Score 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.

    Time frame: At Week 12

  7. Change From Baseline in CDAI Score

    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.

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

  8. Percent Change From Baseline in CDAI Score

    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.

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

  9. Change From Baseline in PRO2

    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.

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

  10. Percent Change From Baseline in PRO2

    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.

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

  11. Change From Baseline in SES-CD Score at Week 12

    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.

    Time frame: Baseline, at Week 12

  12. Percent Change From Baseline in SES-CD Score at Week 12

    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.

    Time frame: Baseline, at Week 12

  13. Percentage of Participants Who Achieved Steroid-free Remission up to Week 64

    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.

    Time frame: Up to Week 64

  14. Percentage of Participants Who Achieved Steroid-free Improvement up to Week 64

    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.

    Time frame: Up to Week 64

  15. Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64

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

    Time frame: Baseline up to Week 64

  16. Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64

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

    Time frame: Baseline up to Week 64

07

Results

Posted Apr 2, 2025

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.

Remission-induction Period: (Weeks 0-12)
Participant flow — Remission-induction Period: (Weeks 0-12)
MilestoneE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Started1213
Cdai responders at week 1256
Cdai non-responders at week 1257
Completed1013
Not completed20
Withdrew: Withdrawal by subject20
Rescue Period: (Weeks 12 to 24)
Participant flow — Rescue Period: (Weeks 12 to 24)
MilestoneE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Started57
Cdai responders at week 2422
Cdai non-responders at week 2421
Completed43
Not completed14
Withdrew: Withdrawal by subject12
Withdrew: Progressive disease02
Extension Period:(Week 12-52/Week 24-64)
Participant flow — Extension Period:(Week 12-52/Week 24-64)
MilestoneE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Started78
Completed25
Not completed53
Withdrew: Lack of efficacy11
Withdrew: Progressive disease10
Withdrew: Other32
Post-observation Period
Participant flow — Post-observation Period
MilestoneE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Started1213
Completed1213
Not completed00

Outcome measures

PrimaryPercentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12

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.

Time frame:
At Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 1233.3 (9.9 to 65.1)23.1 (5.0 to 53.8)
Statistical analysis
  • E6011 10 mg/kg vs Placebo Then E6011 10 mg/kg · Difference: 10.3 · 95% CI -24.9 to 45.4The difference of percentage was calculated as E6011 minus placebo.
SecondaryPercentage of Participants With CR70 and CR100

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.

Time frame:
At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Reported as:
Number · percentage of participants
Percentage of Participants With CR70 and CR100
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
CR70: Week 216.723.1
CR70: Week 445.523.1
CR70: Week 850.038.5
CR70: Week 1250.046.2
CR70: Week 1425.033.3
CR70: Week 1670.060.0
CR70: Week 2066.762.5
CR70: Week 2462.571.4
CR70: Week 28100.085.7
CR70: Week 3250.083.3
CR70: Week 36100.083.3
CR70: Week 40100.075.0
CR70: Week 44100.080.0
CR70: Week 4866.7100.0
CR70: Week 5266.766.7
CR70: Week 56—100.0
CR70: Week 60—100.0
CR70: Week 64—100.0
CR100: Week 216.715.4
CR100: Week 418.223.1
CR100: Week 830.030.8
CR100: Week 1240.023.1
CR100: Week 1425.033.3
CR100: Week 1670.050.0
CR100: Week 2055.650.0
CR100: Week 2450.057.1
CR100: Week 28100.071.4
CR100: Week 3250.083.3
CR100: Week 3675.050.0
CR100: Week 40100.075.0
CR100: Week 4466.780.0
CR100: Week 4866.775.0
CR100: Week 5266.766.7
CR100: Week 56—100.0
CR100: Week 60—50.0
CR100: Week 64—100.0
SecondaryPercentage of Participants With Below 150 CDAI Points

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.

Time frame:
At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Reported as:
Number · percentage of participants
Percentage of Participants With Below 150 CDAI Points
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
CDAI <150 points: Week 20.07.7
CDAI <150 points: Week 40.015.4
CDAI <150 points: Week 820.030.8
CDAI <150 points: Week 1210.015.4
CDAI <150 points: Week 140.016.7
CDAI <150 points: Week 1620.030.0
CDAI <150 points: Week 2011.137.5
CDAI <150 points: Week 2412.542.9
CDAI <150 points: Week 28100.042.9
CDAI <150 points: Week 3250.083.3
CDAI <150 points: Week 3625.033.3
CDAI <150 points: Week 4066.750.0
CDAI <150 points: Week 4433.360.0
CDAI <150 points: Week 480.050.0
CDAI <150 points: Week 5233.366.7
CDAI <150 points: Week 56—100.0
CDAI <150 points: Week 60—50.0
CDAI <150 points: Week 64—100.0
SecondaryPercentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)

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.

Time frame:
At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Reported as:
Number · percentage of participants
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
>=5-point reduction: Week 225.038.5
>=5-point reduction: Week 445.538.5
>=5-point reduction: Week 860.053.8
>=5-point reduction: Week 1250.053.8
>=5-point reduction: Week 1425.050.0
>=5-point reduction: Week 1670.060.0
>=5-point reduction: Week 2077.875.0
>=5-point reduction: Week 2462.571.4
>=5-point reduction: Week 28100.085.7
>=5-point reduction: Week 3250.0100.0
>=5-point reduction: Week 3675.083.3
>=5-point reduction: Week 40100.050.0
>=5-point reduction: Week 44100.060.0
>=5-point reduction: Week 48100.075.0
>=5-point reduction: Week 52100.066.7
>=5-point reduction: Week 56—100.0
>=5-point reduction: Week 60—100.0
>=5-point reduction: Week 64—100.0
>=8-point reduction: Week 216.715.4
>=8-point reduction: Week 427.330.8
>=8-point reduction: Week 840.030.8
>=8-point reduction: Week 1240.030.8
>=8-point reduction: Week 1425.016.7
>=8-point reduction: Week 1660.040.0
>=8-point reduction: Week 2055.662.5
>=8-point reduction: Week 2450.057.1
>=8-point reduction: Week 28100.057.1
>=8-point reduction: Week 3250.066.7
>=8-point reduction: Week 3675.033.3
>=8-point reduction: Week 40100.050.0
>=8-point reduction: Week 44100.060.0
>=8-point reduction: Week 48100.075.0
>=8-point reduction: Week 5266.766.7
>=8-point reduction: Week 56—100.0
>=8-point reduction: Week 60—50.0
>=8-point reduction: Week 64—100.0
SecondaryPercentage of Participants With Below 8 Points in PRO2

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.

Time frame:
At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Reported as:
Number · percentage of participants
Percentage of Participants With Below 8 Points in PRO2
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
PRO2 <8 points: Week 28.37.7
PRO2 <8 points: Week 49.17.7
PRO2 <8 points: Week 820.023.1
PRO2 <8 points: Week 1210.015.4
PRO2 <8 points: Week 140.016.7
PRO2 <8 points: Week 1610.030.0
PRO2 <8 points: Week 200.037.5
PRO2 <8 points: Week 2412.528.6
PRO2 <8 points: Week 2825.014.3
PRO2 <8 points: Week 3225.033.3
PRO2 <8 points: Week 360.016.7
PRO2 <8 points: Week 4033.325.0
PRO2 <8 points: Week 440.040.0
PRO2 <8 points: Week 480.050.0
PRO2 <8 points: Week 5233.366.7
PRO2 <8 points: Week 56—100.0
PRO2 <8 points: Week 60—50.0
PRO2 <8 points: Week 64—100.0
SecondaryPercentage of Participants With at Least 50 Percent (%) Improvement in (Endoscopic Response) Simple Endoscopic Score for Crohn's Disease (SES-CD) Score 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.

Time frame:
At Week 12
Reported as:
Number · percentage of participants
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
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percentage of Participants With at Least 50 Percent (%) Improvement in (Endoscopic Response) Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 128.3 (0.2 to 38.5)15.4 (1.9 to 45.4)
Statistical analysis
  • E6011 10 mg/kg vs Placebo Then E6011 10 mg/kg · Difference: -7.1 · 95% CI -32.1 to 18.0The difference of percentage was calculated as E6011 minus placebo.
SecondaryPercentage of Participants With Less Than or Equal to (<=) 2 (Endoscopic Remission) SES-CD Score 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.

Time frame:
At Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Less Than or Equal to (<=) 2 (Endoscopic Remission) SES-CD Score at Week 12
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percentage of Participants With Less Than or Equal to (<=) 2 (Endoscopic Remission) SES-CD Score at Week 128.3 (0.2 to 38.5)0.0 (0.0 to 24.7)
Statistical analysis
  • E6011 10 mg/kg vs Placebo Then E6011 10 mg/kg · Difference: 8.3 · 95% CI -7.3 to 24.0The difference of percentage was calculated as E6011 minus placebo.
SecondaryChange From Baseline in CDAI Score

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.

Time frame:
Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Reported as:
Mean · score on a scale
Change From Baseline in CDAI Score
score on a scaleE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Change at Week 2-38.0 ± 96.1-50.3 ± 56.7
Change at Week 4-60.5 ± 102.7-64.5 ± 91.0
Change at Week 8-92.8 ± 109.8-70.5 ± 113.3
Change at Week 12-92.4 ± 109.0-69.6 ± 107.0
Change at Week 14-22.0 ± 78.1-25.8 ± 100.8
Change at Week 16-102.8 ± 95.2-89.3 ± 120.1
Change at Week 20-115.4 ± 66.1-119.1 ± 136.4
Change at Week 24-115.5 ± 90.1-100.0 ± 120.3
Change at Week 28-160.7 ± 28.1-153.1 ± 93.5
Change at Week 32-97.3 ± 95.1-183.7 ± 79.1
Change at Week 36-136.0 ± 44.2-143.0 ± 109.8
Change at Week 40-173.7 ± 49.0-157.0 ± 84.0
Change at Week 44-147.3 ± 75.8-185.2 ± 102.9
Change at Week 48-127.3 ± 56.1-209.8 ± 99.2
Change at Week 52-103.7 ± 102.8-171.3 ± 162.4
Change at Week 56—-211.0 ± NA
Change at Week 60—-145.0 ± 97.6
Change at Week 64—-240.0 ± NA
SecondaryPercent Change From Baseline in CDAI Score

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.

Time frame:
Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Reported as:
Mean · percent change
Percent Change From Baseline in CDAI Score
percent changeE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percent Change at Week 2-8.9 ± 24.6-16.7 ± 21.1
Percent Change at Week 4-16.0 ± 26.1-20.6 ± 26.6
Percent Change at Week 8-25.8 ± 27.7-23.1 ± 37.1
Percent Change at Week 12-25.3 ± 27.1-21.8 ± 33.9
Percent Change at Week 14-8.3 ± 28.4-9.3 ± 36.6
Percent Change at Week 16-29.3 ± 23.6-27.5 ± 37.0
Percent Change at Week 20-34.5 ± 17.5-36.6 ± 45.4
Percent Change at Week 24-34.8 ± 25.3-32.6 ± 44.1
Percent Change at Week 28-53.6 ± 3.4-48.3 ± 26.2
Percent Change at Week 32-31.4 ± 29.3-60.1 ± 28.3
Percent Change at Week 36-43.3 ± 10.3-43.5 ± 30.2
Percent Change at Week 40-53.9 ± 15.7-50.2 ± 23.7
Percent Change at Week 44-45.7 ± 23.1-56.8 ± 27.1
Percent Change at Week 48-39.6 ± 17.8-63.7 ± 25.5
Percent Change at Week 52-33.0 ± 32.4-53.8 ± 48.2
Percent Change at Week 56—-77.0 ± NA
Percent Change at Week 60—-51.9 ± 37.1
Percent Change at Week 64—-87.6 ± NA
SecondaryChange From Baseline in PRO2

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.

Time frame:
Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Reported as:
Mean · score on a scale
Change From Baseline in PRO2
score on a scaleE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Change at Week 2-3.1 ± 6.5-4.3 ± 4.0
Change at Week 4-5.3 ± 6.6-4.9 ± 6.5
Change at Week 8-6.9 ± 7.3-5.8 ± 7.1
Change at Week 12-6.5 ± 6.2-5.5 ± 6.7
Change at Week 14-3.0 ± 6.7-2.7 ± 5.4
Change at Week 16-8.1 ± 5.7-6.1 ± 7.6
Change at Week 20-7.9 ± 4.2-8.3 ± 9.2
Change at Week 24-6.5 ± 6.4-6.9 ± 7.4
Change at Week 28-9.0 ± 1.0-9.6 ± 5.7
Change at Week 32-5.5 ± 6.1-12.0 ± 6.2
Change at Week 36-9.0 ± 7.0-9.0 ± 6.1
Change at Week 40-13.0 ± 1.7-6.3 ± 6.8
Change at Week 44-11.0 ± 2.0-9.4 ± 7.7
Change at Week 48-8.7 ± 0.6-11.8 ± 6.6
Change at Week 52-8.3 ± 3.1-11.0 ± 8.5
Change at Week 56—-13.0 ± NA
Change at Week 60—-9.5 ± 6.4
Change at Week 64—-15.0 ± NA
SecondaryPercent Change From Baseline in PRO2

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.

Time frame:
At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Reported as:
Mean · percent change
Percent Change From Baseline in PRO2
percent changeE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percent Change at Week 2-13.5 ± 31.3-20.9 ± 20.0
Percent Change at Week 4-23.0 ± 29.8-22.9 ± 28.4
Percent Change at Week 8-30.1 ± 33.0-29.2 ± 34.6
Percent Change at Week 12-29.4 ± 28.0-25.8 ± 31.0
Percent Change at Week 14-13.4 ± 28.6-17.6 ± 32.7
Percent Change at Week 16-36.8 ± 25.0-27.9 ± 34.4
Percent Change at Week 20-36.2 ± 16.8-37.6 ± 46.7
Percent Change at Week 24-30.0 ± 28.0-35.9 ± 41.1
Percent Change at Week 28-47.7 ± 9.2-46.2 ± 23.7
Percent Change at Week 32-25.1 ± 32.7-58.3 ± 30.3
Percent Change at Week 36-37.1 ± 25.5-42.9 ± 24.6
Percent Change at Week 40-56.4 ± 14.3-31.2 ± 32.6
Percent Change at Week 44-46.9 ± 9.1-45.3 ± 32.5
Percent Change at Week 48-37.3 ± 7.2-57.2 ± 26.7
Percent Change at Week 52-38.4 ± 22.2-56.1 ± 34.6
Percent Change at Week 56—-81.3 ± NA
Percent Change at Week 60—-59.4 ± 39.8
Percent Change at Week 64—-93.8 ± NA
SecondaryChange From Baseline in SES-CD Score at Week 12

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.

Time frame:
Baseline, at Week 12
Reported as:
Mean · score on a scale
Change From Baseline in SES-CD Score at Week 12
score on a scaleE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Change From Baseline in SES-CD Score at Week 121.4 ± 4.9-3.5 ± 4.9
SecondaryPercent Change From Baseline in SES-CD Score at Week 12

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.

Time frame:
Baseline, at Week 12
Reported as:
Mean · percent change
Percent Change From Baseline in SES-CD Score at Week 12
percent changeE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percent Change From Baseline in SES-CD Score at Week 12-0.3 ± 45.6-19.2 ± 33.2
SecondaryPercentage of Participants Who Achieved Steroid-free Remission up to Week 64

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.

Time frame:
Up to Week 64
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Steroid-free Remission up to Week 64
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percentage of Participants Who Achieved Steroid-free Remission up to Week 6400
SecondaryPercentage of Participants Who Achieved Steroid-free Improvement up to Week 64

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.

Time frame:
Up to Week 64
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Steroid-free Improvement up to Week 64
percentage of participantsE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percentage of Participants Who Achieved Steroid-free Improvement up to Week 6400
SecondaryChange From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64

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

Time frame:
Baseline up to Week 64
Reported as:
Mean · milligram per day (mg/day)
Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64
milligram per day (mg/day)E6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 640 ± 00 ± 0
SecondaryPercent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64

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

Time frame:
Baseline up to Week 64
Reported as:
Mean · percent change
Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64
percent changeE6011 10 mg/kgPlacebo Then E6011 10 mg/kg
Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 640 ± 00 ± 0

Adverse events

Collected over 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. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Remission Induction Period: E6011 10 mg/kg0/12 (0%)0/12 (0%)6/12 (50%)
Remission Induction Period: Placebo0/13 (0%)1/13 (7.7%)5/13 (38.5%)
Rescue Period: E6011 10 mg/kg0/5 (0%)0/5 (0%)3/5 (60%)
Rescue Period: Placebo to E6011 10 mg/kg0/7 (0%)2/7 (28.6%)4/7 (57.1%)
Extension Period: E6011 10 mg/kg0/7 (0%)0/7 (0%)1/7 (14.3%)
Extension Period: Placebo to E6011 10 mg/kg0/8 (0%)0/8 (0%)5/8 (62.5%)
Post-observation Period: E6011 10 mg/kg0/12 (0%)0/12 (0%)2/12 (16.7%)
Post-observation Period: Placebo to E6011 10 mg/kg0/13 (0%)1/13 (7.7%)1/13 (7.7%)
Most frequent serious events
Most frequent serious events
EventRemission Induction Period: E6011 10 mg/kgRemission Induction Period: PlaceboRescue Period: E6011 10 mg/kgRescue Period: Placebo to E6011 10 mg/kgExtension Period: E6011 10 mg/kgExtension Period: Placebo to E6011 10 mg/kgPost-observation Period: E6011 10 mg/kgPost-observation Period: Placebo to E6011 10 mg/kg
Crohn's DiseaseGastrointestinal disorders0/120/130/51/70/70/80/121/13
Lower Gastrointestinal HaemorrhageGastrointestinal disorders0/120/130/51/70/70/80/120/13
HypokalaemiaMetabolism and nutrition disorders0/121/130/50/70/70/80/120/13
Most frequent other events
Showing 10 of 27
Most frequent other events
EventRemission Induction Period: E6011 10 mg/kgRemission Induction Period: PlaceboRescue Period: E6011 10 mg/kgRescue Period: Placebo to E6011 10 mg/kgExtension Period: E6011 10 mg/kgExtension Period: Placebo to E6011 10 mg/kgPost-observation Period: E6011 10 mg/kgPost-observation Period: Placebo to E6011 10 mg/kg
PyrexiaGeneral disorders1/120/131/52/70/70/80/120/13
Muscle SpasmsMusculoskeletal and connective tissue disorders0/120/131/50/70/70/80/120/13
DysuriaRenal and urinary disorders0/120/131/50/70/70/80/120/13
Blood Creatine Phosphokinase IncreasedInvestigations0/120/131/50/70/70/80/120/13
Covid-19Infections and infestations1/120/130/51/70/70/80/120/13
Upper Respiratory Tract InfectionInfections and infestations0/120/130/51/70/71/80/120/13
Weight DecreasedInvestigations0/120/130/51/70/70/80/120/13
Immunisation ReactionImmune system disorders0/120/130/50/71/70/81/120/13
ConjunctivitisInfections and infestations0/120/130/50/70/71/80/120/13
Respiratory Tract InfectionInfections and infestations0/120/130/50/70/71/80/120/13

Baseline characteristics

The full analysis set (FAS) included participants to whom the investigational medicinal product (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).

Age, Continuous
Age, Continuous(years)E6011 10 mg/kgPlacebo Then E6011 10 mg/kgTotal
Mean29.8 ± 8.733.2 ± 12.031.5 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)E6011 10 mg/kgPlacebo Then E6011 10 mg/kgTotal
Female257
Male10818
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)E6011 10 mg/kgPlacebo Then E6011 10 mg/kgTotal
Hispanic or Latino000
Not Hispanic or Latino121325
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)E6011 10 mg/kgPlacebo Then E6011 10 mg/kgTotal
American Indian or Alaska Native000
Asian11920
Native Hawaiian or Other Pacific Islander000
Black or African American000
White145
More than one race000
Unknown or Not Reported000
08

Study locations

46 sites
  • 49, CCR Ostrava, s.r.o
    Ostrava, Czechia
  • 15, University of Debrecen Clinical Centre
    Debrecen, Hungary
  • 19, Semmelweis university
    Győr, Hungary
  • 4
    Nagoya, Aichi, Japan
  • 17
    Toyota, Aichi, Japan
  • 10
    Abiko, Chiba, Japan
  • 31
    Kashiwa, Chiba, Japan
  • 27
    Kitakyushu, Fukuoka, Japan
  • 39
    Kitakyushu, Fukuoka, Japan
  • 29
    Kasamatsu, Gifu, Japan
  • 41
    Kure, Hiroshima, Japan
  • 38
    Asahikawa, Hokkaido, Japan
  • 26
    Sapporo, Hokkaido, Japan
  • 37
    Kobe, Hyogo, Japan
  • 7
    Nishinomiya, Hyogo, Japan
  • 32
    Kanazawa, Ishikawa, Japan
  • 8
    Takamatsu, Kagawa, Japan
  • 52
    Isehara, Kanagawa, Japan
  • 30
    Ōiso, Kanagawa, Japan
  • 28
    Urasoe, Okinawa, Japan
  • 42
    Hirakata, Osaka, Japan
  • 51
    Hamamatsu, Shizuoka, Japan
  • 50
    Shuntougun, Shizuoka, Japan
  • 2
    Bunkyo, Tokyo, Japan
  • 33
    Hachiōji, Tokyo, Japan
  • 34
    Kodaira, Tokyo, Japan
  • 3
    Minato, Tokyo, Japan
  • 6
    Mitaka, Tokyo, Japan
  • 43
    Shinagawa-Ku, Tokyo, Japan
  • 1
    Shinjuku, Tokyo, Japan
  • 36
    Akita, Japan
  • 25
    Fukuoka, Japan
  • 35
    Fukuoka, Japan
  • 11
    Gifu, Japan
  • 5
    Kagoshima, Japan
  • 40
    Kanazawa, Japan
  • 24
    Osaka, Japan
  • 21, Vitamed Galaj i Cichomski sp.j.
    Bydgoszcz, Poland
  • 22, Vita Longa
    Katowice, Poland
  • 20, Clinical Research Center sp. z o.o., Medic-R Sp. k.
    Poznań, Poland
  • 23, Centrum Badań Klinicznych - Ośrodek Badań Wczesnej Fazy
    Wrocław, Poland
  • 45, Federal Siberian Research and Clinical Center
    Krasnoyarsk, Russian Federation
  • 44, LLC, Novosibirskiy Gastrocenter
    Novosibirsk, Russian Federation
  • 46, Pyatigorsk City Clinical Hospital
    Pyatigorsk, Russian Federation
  • 48, LLC Clinic, UZI 4D
    Pyatigorsk, Russian Federation
  • 47, City Hospital of Saint Martyr Elizaveth
    Saint Petersburg, Russian Federation
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Mar 2022, 34 months.

Results were first posted in Apr 2025, 3 years after primary completion.

Of 55 industry-sponsored phase 2 interventional studies under Crohn Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 45. This study's 34 months is close to that.

Counting every sponsor, half of 82 studies reached it within 34 months; a quarter within 23 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2018
First posted
Nov 7, 2018
StartActual
Apr 25, 2019
Primary completionActual
Mar 16, 2022
CompletionActual
Apr 3, 2024
Results first posted
Apr 2, 2025
Last update
Apr 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03733314
Lead sponsor
EA Pharma Co., Ltd.
Responsible party
Sponsor
First posted
Nov 7, 2018
Start date
Apr 25, 2019
Primary completion
Mar 16, 2022
Completion
Apr 3, 2024
Results posted
Apr 2, 2025
Last update
Apr 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Quetmolimab

Other studies in this condition

Crohn Disease →

Other studies from this sponsor

EA Pharma Co., Ltd. →

Start the discussion