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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03733314
Recruitment Status : Active, not recruiting
First Posted : November 7, 2018
Last Update Posted : March 3, 2023
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( EA Pharma Co., Ltd. )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: E6011 Drug: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : October 17, 2022
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: E6011 Drug: E6011
E6011, infusion, intravenously.
Placebo Comparator: Placebo Drug: Placebo
Placebo, infusion, intravenously.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Clinical Response (CR) 100 (CR100) [ Time Frame: Week 12 ]
    CR100 is defined as clinical response with a decrease of greater than or equal to (>=) 100 points in CDAI score from Baseline. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.


Secondary Outcome Measures :
  1. Percentage of Participants with CR70 and CR100 [ Time Frame: Up to Week 64 ]
    CR70 is defined as CR with a decrease of >=70 points in CDAI score from baseline. CR100 is defined as clinical response with a decrease of >=100 points in CDAI score from baseline. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

  2. Percentage of Participants With Below 150 Points (CDAI Remission Rate) [ Time Frame: Up to Week 64 ]
    CDAI remission is defined as CDAI score below 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

  3. Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2) [ Time Frame: Up to Week 64 ]
    Patient reported outcome 2-clinical response 5 (PRO2-CR5) is defined as CR with a decrease of 5 or more points in PRO2 score from baseline. Patient reported outcome 2-clinical response 8 (PRO2-CR8) is defined as CR with a decrease of 8 or more points in PRO2 score from baseline. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.

  4. Percentage of Participants With Below 8 Points (PRO2-remission Rate) [ Time Frame: Up to Week 64 ]
    PRO2-remission is defined as PRO2 below 8 points. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.

  5. Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Score [ Time Frame: Week 12 ]
    Endoscopic response is defined as a decrease in SES-CD of at least 50 percent (%) from baseline. SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.

  6. Percentage of Participants With Endoscopic Remission Based on SES-CD Score [ Time Frame: Week 12 ]
    Endoscopic remission is defined as 2 or less points on SES-CD. SES-CD scores are calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: Rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.

  7. Change From Baseline in CDAI Score [ Time Frame: Up to Week 64 ]
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

  8. Percent Change From Baseline in CDAI score [ Time Frame: Up to Week 64 ]
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

  9. Change From Baseline in PRO2 [ Time Frame: Up to Week 64 ]
    PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.

  10. Percent Change From Baseline in PRO2 [ Time Frame: Up to Week 64 ]
    PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.

  11. Change From Baseline in SES-CD Score [ Time Frame: Week 12 ]
    SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.

  12. Percent Change From Baseline in SES-CD Score [ Time Frame: Week 12 ]
    SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.

  13. Percentage of Participants who Achieved Steroid-free Remission [ Time Frame: Up to Week 64 ]
    Steroid-free remission will be achieved through steroid dose reduction and clinical remission (CDAI remission or PRO2-remission). CDAI remission is defined as CDAI score below 150 points. PRO2-remission is defined as PRO2- score less than 8-points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.

  14. Percentage of Participants who Achieved Steroid-Free Improvement [ Time Frame: Up to Week 64 ]
    Steroid-free improvement will be achieved by steroid dose reduction and CR of CR70, CR100, PRO2-CR5 or PRO2-CR8. CR70 is CR with decrease of >=70 points and CR100 is CR with decrease >=100 points in CDAI from Baseline. PRO2-CR5 is CR with decrease of >=5 points and PRO2-CR8 is CR with decrease of >=8 points from baseline. CDAI consisting of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to 600, higher score indicates higher disease activity. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.

  15. Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids [ Time Frame: Up to Week 64 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.
  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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733314


Locations
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Sponsors and Collaborators
EA Pharma Co., Ltd.
More Information
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Responsible Party: EA Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03733314    
Other Study ID Numbers: E6011-ET2
2018-002109-70 ( EudraCT Number )
184139 ( Registry Identifier: JapicCTI )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc. ( EA Pharma Co., Ltd. ):
Crohn's Disease
E6011
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal tract
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Quetmolimab
Antirheumatic Agents