A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease

April 28, 2022 updated by: EA Pharma Co., Ltd.
This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of E6011. A total of 24 subjects will enroll into four cohorts. Six subjects per cohort will receive repeated intravenous administration of E6011.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study consists of Screening Phase, Observation Phase, Treatment Phase, Extension Phase, and Follow-up Phase. Screening assessments will be performed between 42 to 2 days before study drug administration. Observation Phase assessments will be performed a day before or on a day of the initial administration to confirm the eligibility of subjects. The eligible subjects will receive the repeated intravenous administration of E6011. E6011 will be dissolved in physiological saline (nearly 100 mL) for approximately 30-minute infusion. During the Treatment Phase, for the first and second cohorts, E6011 will be administered every 2 weeks up to Week 10, a total of 6 times (with a double dose at Week 0). For the third and fourth cohorts, E6011 will be administered at Weeks 0, 1 and 2, then every 2 weeks up to Week 10, a total of 7 times. Under no safety concerns, Crohn's Disease Activity (CDAI) is less than 150 or a decrease in CDAI from the Observation Phase is greater than 70 and a subject intends to continue administrations, the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension Phase). Subjects will be hospitalized for 24 hours after the initial and second administrations for postdose monitoring and will have out-patient monitoring until 12 weeks after the initial administration. If hospitalization is difficult after the second administration, the subjects can be held at the hospital for 6 hours and then allowed to go home after confirmation of the safety. Subjects who roll over onto the Extension Phase will have continued monitoring until 52 weeks after the initial administration. When the subjects complete (Week 12 or Week 52) or discontinue the study, they will undergo an on-site follow-up 28 days after the study completion or discontinuation and an off-site follow-up or telephone interview 70 days after the final administration. The investigator will conduct full assessments of subjects safety next day of the second administration (24 hours after the second administration) to confirm presence of absence of study-related manifestations which may affect the study drug administration of next cohort. When the sponsor is informed of investigator's judgment on the sixth subject in each cohort, the appropriateness of next cohort will be judged based on the safety data available including the judgment of individual investigator on the next day of the second administration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
      • Fukuoka, Japan
      • Kyoto, Japan
      • Osaka, Japan
    • Aichi
      • Nagoya, Aichi, Japan
    • Fukuoka
      • Chikushino, Fukuoka, Japan
      • Kurume, Fukuoka, Japan
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
    • Hyogo
      • Nishinomiya, Hyogo, Japan
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
    • Iwate
      • Morioka, Iwate, Japan
    • Kanagawa
      • Sagamihara, Kanagawa, Japan
    • Mie
      • Tsu, Mie, Japan
    • Okinawa
      • Urazoe, Okinawa, Japan
    • Osaka
      • Takatsuki, Osaka, Japan
    • Tokyo
      • Minato-ku, Tokyo, Japan
      • Shinjuku-ku, Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Subjects must meet all of the following criteria to be included in this study:

  1. Japanese patients aged 20 to 64 years old at the time of informed consent.
  2. Diagnosed with Crohn's disease based on the diagnostic criteria for Crohn's disease of the Health and Labor Sciences Research Grants "Research on Measures against Intractable Diseases (Inflammatory Bowel Disease)" Group (2012).
  3. Mild to moderate severity at Observation Phase (CDAI between 150 and 450, based on the above diagnosis criteria for Crohn's disease).
  4. History of aminosalycylic acid (5-ASA), salazosulfapyridine, cortical steroid, immunomodulators, infliximab or adalimumab treatment with no apparent effect, or unable to continue the treatment due to AEs (except for infliximab and adalimumab).
  5. Consent to use contraception (both the subject and the subject's partner), if the subject is a a man capable of reproduction or a woman of childbearing potential.
  6. Has voluntarily consented, in writing, to participate in this study.
  7. Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

  1. Abscess or suspected abscess found at Screening or Observation Phase (not applicable to perianal abscess).
  2. Diagnosed with gastrointestinal epithelia dysplasia at Screening or Observation Phase.
  3. Suspected of colitis other than Crohn's disease at Screening or Observation Phase (such as pseudomembranous colitis).
  4. Symptomatic obstruction at Screening or Observation Phase.
  5. Underwent intestinal resection within 24 weeks before the start of the study treatment, or planning to undergo intestinal resection in the next 52 weeks.
  6. Newly started with Seaton drainage within 12 weeks before Observation Phase.
  7. Diagnosed with short bowel syndrome at Screening or Observation Phase.
  8. Positive C.Difficile toxin test at Screening.
  9. Prior history or current complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
  10. Immunodeficiency or history of HIV infection.
  11. Infection requiring hospitalization or intravenous administration of antibiotics within 4 weeks before the start of the study treatment; or an infection requiring oral antibiotics within 2 weeks before the start of the study treatment.
  12. History of tuberculosis or current complication of active tuberculosis.
  13. History of serious allergy (shock, or anaphylactoid symptoms).
  14. History of clinically important vascular edema, hematemesis, or hemoptysis.
  15. History of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans.
  16. History of clinically important vasculitis (such as mononeuritis multiplex).
  17. In tests conducted at Screening, a positive finding for any of the following: human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus core antibody (HBc antibody), hepatitis B virus DNA (HBV DNA), hepatitis C virus antibody (HCV antibody), human T-lymphotrophic virus Type I antibody (HTLV-1 antibody), or syphilis screening. Except for the subject, if HBs antibody is only positive and is clear due to vaccination of Hepatitis B.
  18. Any result other than negative in tuberculosis test (T-SPOT TB Test or QuantiFERON TB Gold Test) at Screening.
  19. Findings indicating a history of tuberculosis on chest x-ray during screening.
  20. Received a live vaccine within 12 weeks before starting the study treatment, or planning to receive a live vaccine before Week 52.
  21. Planning to have surgery before Week 52.
  22. Currently participating in another clinical trial, or used an investigational drug or investigational device, or participated in another clinical study, within 24 weeks of the start of the study treatment.
  23. Judged to be ineligible to participate in this study by the investigator or sub-investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
E6011 2 mg/kg
Drug: E6011 2 mg/kg
Experimental: 2
E6011 5 mg/kg
Drug: E6011 5 mg/kg
Experimental: 3
E6011 10 mg/kg
Drug: E6011 10 mg/kg
Experimental: 4
E6011 15 mg/kg
Drug: E6011 15 mg/kg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to Week 62 (70 days after last dose of study drug)
TEAEs was defined as adverse event (AEs) that emerged during the treatment, having been absent at pretreatment (Baseline) or re-emerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
Baseline up to Week 62 (70 days after last dose of study drug)
Number of Participants With Clinically Significant Change in Laboratory Parameters
Time Frame: Baseline up to Week 52
Clinical laboratory parameters included biochemistry, hematology, urinalysis and other screening test. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported.
Baseline up to Week 52
Number of Participants With Clinically Significant Change in Vital Sign Measurements
Time Frame: Baseline up to Week 52
Vital sign measurements included blood pressure (systolic and diastolic blood pressure) and pulse rate. Number of participants with clinically significant change in vital signs measurements which were deemed clinically significant by the investigator were reported.
Baseline up to Week 52
Number of Participants With Treatment-emergent Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Time Frame: Baseline up to Week 52
Number of participants with treatment-emergent clinically significant abnormal ECG findings which were deemed clinically significant by the investigator were reported.
Baseline up to Week 52
Number of Participants With Abnormal Chest X-ray Findings
Time Frame: Baseline up to Week 52
Number of participants with abnormal chest X-ray findings were reported.
Baseline up to Week 52
Number of Participants With Neurological Findings
Time Frame: Baseline up to Week 52
Number of participants with neurological findings were reported.
Baseline up to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Trough Serum Concentration of E6011 at Week 12 and 52
Time Frame: Week 12: Pre-dose; Week 52: Pre-dose
Week 12: Pre-dose; Week 52: Pre-dose
Number of Participants With Serum Anti-E6011 Antibody at Week 12 and 52
Time Frame: At Week 12 and Week 52
Number of participants with serum anti-E6011 antibody were reported.
At Week 12 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EA Pharma Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E6011-J081-101
  • 142543 (JapicCTI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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