Crohn's DiseasePhase 1/2NCT02039063
A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
A Phase 1/2 study testing E6011 2 mg/kg, E6011 5 mg/kg and E6011 10 mg/kg in people with Crohn's Disease, run by EA Pharma Co., Ltd. at 17 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- E6011 2 mg/kg, E6011 5 mg/kg and E6011 10 mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 17 sitesJapan
- Study dates
- 5 Apr 2014to 27 Nov 2017
- Phase
- Phase 1/2
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in this study:
- Japanese patients aged 20 to 64 years old at the time of informed consent.
- 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).
- Mild to moderate severity at Observation Phase (CDAI between 150 and 450, based on the above diagnosis criteria for Crohn's disease).
- 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).
- 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.
- Has voluntarily consented, in writing, to participate in this study.
- Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Abscess or suspected abscess found at Screening or Observation Phase (not applicable to perianal abscess).
- Diagnosed with gastrointestinal epithelia dysplasia at Screening or Observation Phase.
- Suspected of colitis other than Crohn's disease at Screening or Observation Phase (such as pseudomembranous colitis).
- Symptomatic obstruction at Screening or Observation Phase.
- Underwent intestinal resection within 24 weeks before the start of the study treatment, or planning to undergo intestinal resection in the next 52 weeks.
Show all 24Show fewer
- Newly started with Seaton drainage within 12 weeks before Observation Phase.
- Diagnosed with short bowel syndrome at Screening or Observation Phase.
- Positive C.Difficile toxin test at Screening.
- Prior history or current complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
- Immunodeficiency or history of HIV infection.
- 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.
- History of tuberculosis or current complication of active tuberculosis.
- History of serious allergy (shock, or anaphylactoid symptoms).
- History of clinically important vascular edema, hematemesis, or hemoptysis.
- History of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans.
- History of clinically important vasculitis (such as mononeuritis multiplex).
- 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.
- Any result other than negative in tuberculosis test (T-SPOT TB Test or QuantiFERON TB Gold Test) at Screening.
- Findings indicating a history of tuberculosis on chest x-ray during screening.
- Received a live vaccine within 12 weeks before starting the study treatment, or planning to receive a live vaccine before Week 52.
- Planning to have surgery before Week 52.
- 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.
- Judged to be ineligible to participate in this study by the investigator or sub-investigator
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Study site
Asahikawa, Hokkaido
Study site
Chiba
Study site
Chikushino-shi, Fukuoka
Study site
Fukuoka
Study site
Kanazawa, Ishikawa-ken
Study site
Kurume, Fukuoka
Study site
Kyoto
Study site
Minato-ku, Tokyo
Study site
Morioka, Iwate
Study site
Nagoya, Aichi-ken
Study site
Nishinomiya, Hyōgo
Study site
Osaka
Study site
Sagamihara, Kanagawa
Study site
Shinjuku-ku, Tokyo
Study site
Takatsuki, Osaka
Study site
Tsu, Mie-ken
Study site
Urazoe, Okinawa
About this study
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- E6011 2 mg/kg, E6011 5 mg/kg, E6011 10 mg/kg, E6011 15 mg/kg
- Keywords
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6011 2 mg/kgDrug
E6011 5 mg/kgDrug
E6011 10 mg/kgDrug
E6011 15 mg/kgDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | E6011 2 mg/kg Receives: Drug: E6011 2 mg/kg |
| 2 | Experimental | E6011 5 mg/kg Receives: Drug: E6011 5 mg/kg |
| 3 | Experimental | E6011 10 mg/kg Receives: Drug: E6011 10 mg/kg |
| 4 | Experimental | E6011 15 mg/kg Receives: Drug: E6011 15 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Measured: Baseline up to Week 62 (70 days after last dose of study drug)
Number of Participants With Clinically Significant Change in Laboratory Parameters
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.
Measured: Baseline up to Week 52
Number of Participants With Clinically Significant Change in Vital Sign Measurements
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.
Measured: Baseline up to Week 52
Number of Participants With Treatment-emergent Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Number of participants with treatment-emergent clinically significant abnormal ECG findings which were deemed clinically significant by the investigator were reported.
Measured: Baseline up to Week 52
Number of Participants With Abnormal Chest X-ray Findings
Number of participants with abnormal chest X-ray findings were reported.
Measured: Baseline up to Week 52
Number of Participants With Neurological Findings
Number of participants with neurological findings were reported.
Measured: Baseline up to Week 52
Secondary outcomes (2)
Mean Trough Serum Concentration of E6011 at Week 12 and 52
Measured: Week 12: Pre-dose; Week 52: Pre-dose
Number of Participants With Serum Anti-E6011 Antibody at Week 12 and 52
Number of participants with serum anti-E6011 antibody were reported.
Measured: At Week 12 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study start5 Apr 2014
- Primary completion6 Jan 2017
- Study completion27 Nov 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 28 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
- NCT02039063
- Sponsor's protocol ID
- E6011-J081-101
- Other IDs
- 142543
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2014
- Last updated
- 30 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Matsuoka K, Naganuma M, Hibi T, Tsubouchi H, Oketani K, Katsurabara T, Hojo S, Takenaka O, Kawano T, Imai T, Kanai T. Phase 1 study on the safety and efficacy of E6011, antifractalkine antibody, in patients with Crohn's disease. J Gastroenterol Hepatol. 2021 Aug;36(8):2180-2186. doi: 10.1111/jgh.15463. Epub 2021 Mar 31.
PubMed 33599356
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02039063
- Acronym / sponsor ID
- E6011-J081-101
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2014 (actual)
- Primary completion
- 6 Jan 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 30 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E6011 2 mg/kgE6011 2 mg/kg |
| 2 | Experimental | Drug: E6011 5 mg/kgE6011 5 mg/kg |
| 3 | Experimental | Drug: E6011 10 mg/kgE6011 10 mg/kg |
| 4 | Experimental | Drug: E6011 15 mg/kgE6011 15 mg/kg |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Japanese patients aged 20 to 64 years old at the time of informed consent.
- 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).
- Mild to moderate severity at Observation Phase (CDAI between 150 and 450, based on the above diagnosis criteria for Crohn's disease).
- 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).
- 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.
Key exclusion criteria (24 listed)
- Abscess or suspected abscess found at Screening or Observation Phase (not applicable to perianal abscess).
- Diagnosed with gastrointestinal epithelia dysplasia at Screening or Observation Phase.
- Suspected of colitis other than Crohn's disease at Screening or Observation Phase (such as pseudomembranous colitis).
- Symptomatic obstruction at Screening or Observation Phase.
- Underwent intestinal resection within 24 weeks before the start of the study treatment, or planning to undergo intestinal resection in the next 52 weeks.
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 |
|---|---|---|
| E6011 2 mg/kg | Drug | 1 |
| E6011 5 mg/kg | Drug | 2 |
| E6011 10 mg/kg | Drug | 3 |
| E6011 15 mg/kg | Drug | 4 |
Primary outcome
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.
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.
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.
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.
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.
Number of Participants With Neurological Findings
Time frame: Baseline up to Week 52
Number of participants with neurological findings were reported.
2 secondary outcomes
Mean Trough Serum Concentration of E6011 at Week 12 and 52
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33599356Matsuoka K, Naganuma M, Hibi T, Tsubouchi H, Oketani K, Katsurabara T, Hojo S, Takenaka O, Kawano T, Imai T, Kanai T. Phase 1 study on the safety and efficacy of E6011, antifractalkine antibody, in patients with Crohn's disease. J Gastroenterol Hepatol. 2021 Aug;36(8):2180-2186. doi: 10.1111/jgh.15463. Epub 2021 Mar 31.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing E6011 2 mg/kg, E6011 5 mg/kg and E6011 10 mg/kg in people with Crohn's Disease, run by EA Pharma Co., Ltd. at 17 sites in Japan.
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 8 inclusion and 24 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 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 30 Jan 2023). 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?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02039063, which also lists 1 linked publication.
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 30 Jan 2023.