Crohn's DiseasePhase 2NCT03733314
A Study of E6011 in Participants With Active Crohn's Disease
A Phase 2 study testing E6011 in people with Crohn's Disease, run by EA Pharma Co., Ltd. at 46 sites in 5 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- E6011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 46 sitesin 5 countries
- Study dates
- 25 Apr 2019to 3 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- With a baseline (at week 0 before the start of investigational 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.
- 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.
- 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).
- 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.
- 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.
- 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.
Who cannot join
- Diagnosed with ulcerative colitis or indeterminate colitis.
- Diagnosed with gastrointestinal epithelial dysplasia.
- Who have an abscess or are suspected to have one.
- With an artificial anus, ileo-anal pouch or fistula.
- 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.).
- Who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.
Trial locations and contacts
46 sites in 5 countries.
46 sites in 5 countries
Japan34 sites
10
Abiko, Chiba
36
Akita
38
Asahikawa, Hokkaido
2
Bunkyo, Tokyo
25
Fukuoka
35
Fukuoka
11
Gifu
33
Hachiōji, Tokyo
51
Hamamatsu, Shizuoka
42
Hirakata, Osaka
52
Isehara, Kanagawa
5
Kagoshima
32
Kanazawa, Ishikawa-ken
40
Kanazawa
29
Kasamatsuchō, Gifu
31
Kashiwa, Chiba
27
Kitakyushu, Fukuoka
39
Kitakyushu, Fukuoka
37
Kobe, Hyōgo
34
Kodaira, Tokyo
41
Kure, Hiroshima
3
Minato, Tokyo
6
Mitaka, Tokyo
4
Nagoya, Aichi-ken
7
Nishinomiya, Hyōgo
30
Ōiso, Kanagawa
24
Osaka
26
Sapporo, Hokkaido
43
Shinagawa-Ku, Tokyo
1
Shinjuku, Tokyo
50
Shuntougun, Shizuoka
8
Takamatsu, Kagawa-ken
17
Toyota, Aichi-ken
28
Urasoe, Okinawa
Russia5 sites
45, Federal Siberian Research and Clinical Center
Krasnoyarsk
44, LLC, Novosibirskiy Gastrocenter
Novosibirsk
46, Pyatigorsk City Clinical Hospital
Pyatigorsk
48, LLC Clinic, UZI 4D
Pyatigorsk
47, City Hospital of Saint Martyr Elizaveth
Saint Petersburg
Poland4 sites
21, Vitamed Galaj i Cichomski sp.j.
Bydgoszcz
22, Vita Longa
Katowice
20, Clinical Research Center sp. z o.o., Medic-R Sp. k.
Poznan
23, Centrum Badań Klinicznych - Ośrodek Badań Wczesnej Fazy
Wroclaw
Hungary2 sites
15, University of Debrecen Clinical Centre
Debrecen
19, Semmelweis university
Győr
About this study
Official title: Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease
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.
- Conditions
- Crohn's Disease
- Being tested
- E6011, Placebo
- Keywords
- Crohn's Disease, E6011, Inflammatory Bowel Diseases, Gastroenteritis, Gastrointestinal tract
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6011Drug
E6011, infusion, intravenously.
PlaceboDrug
Placebo, infusion, intravenously.
| Study group | Role | What they receive |
|---|---|---|
| E6011 | Experimental | Not described Receives: Drug: E6011 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 12
Secondary outcomes (16)
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.
Measured: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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.
Measured: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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.
Measured: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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.
Measured: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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.
Measured: At Week 12
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.
Measured: At Week 12
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.
Measured: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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.
Measured: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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.
Measured: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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.
Measured: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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.
Measured: Baseline, at Week 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.
Measured: Baseline, at Week 12
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.
Measured: Up to Week 64
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.
Measured: Up to Week 64
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.
Measured: Baseline up to Week 64
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.
Measured: Baseline up to Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start25 Apr 2019
- Primary completion16 Mar 2022
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- EA Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733314
- Sponsor's protocol ID
- E6011-ET2
- Other IDs
- 2018-002109-70, 184139, 2018
- Status last verified
- Apr 2025
- First submitted
- 5 Nov 2018
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT03733314
- Acronym / sponsor ID
- E6011-ET2
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, E6011, Inflammatory Bowel Diseases, Gastroenteritis, Gastrointestinal tract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E6011 | Experimental | Drug: E6011 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- With a baseline (at week 0 before the start of investigational 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.
- 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.
- 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).
- 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.
Key exclusion criteria (6 listed)
- Diagnosed with ulcerative colitis or indeterminate colitis.
- Diagnosed with gastrointestinal epithelial dysplasia.
- Who have an abscess or are suspected to have one.
- With an artificial anus, ileo-anal pouch or fistula.
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E6011E6011, infusion, intravenously. | Drug | E6011 |
| PlaceboPlacebo, infusion, intravenously. | Drug | Placebo |
Primary outcome
Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12
Time frame: 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.
16 secondary outcomes
Percentage of Participants With CR70 and CR100
Time frame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Percentage of Participants With Below 150 CDAI Points
Time frame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)
Time frame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Percentage of Participants With Below 8 Points in PRO2
Time frame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
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
Time frame: At Week 12
Percentage of Participants With Less Than or Equal to (<=) 2 (Endoscopic Remission) SES-CD Score at Week 12
Time frame: At Week 12
Change From Baseline in CDAI Score
Time frame: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Percent Change From Baseline in CDAI Score
Time frame: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Change From Baseline in PRO2
Time frame: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Percent Change From Baseline in PRO2
Time frame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Change From Baseline in SES-CD Score at Week 12
Time frame: Baseline, at Week 12
Percent Change From Baseline in SES-CD Score at Week 12
Time frame: Baseline, at Week 12
Percentage of Participants Who Achieved Steroid-free Remission up to Week 64
Time frame: Up to Week 64
Percentage of Participants Who Achieved Steroid-free Improvement up to Week 64
Time frame: Up to Week 64
Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64
Time frame: Baseline up to Week 64
Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64
Time frame: Baseline up to Week 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E6011 in people with Crohn's Disease, run by EA Pharma Co., Ltd. at 46 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Japan, Russia, Poland, Hungary, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12 (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.