Adults 20 to 64, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Primary· 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 occurren
TEAE
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
6
Cohort 2: E6011 5 mg/kg
6
Cohort 3: E6011 10 mg/kg
7
Cohort 4: E6011 15 mg/kg
3
SAE
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
1
Cohort 2: E6011 5 mg/kg
1
Cohort 3: E6011 10 mg/kg
5
Cohort 4: E6011 15 mg/kg
0
Number of Participants With Clinically Significant Change in Laboratory ParametersPrimary· 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.
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
0
Cohort 2: E6011 5 mg/kg
0
Cohort 3: E6011 10 mg/kg
0
Cohort 4: E6011 15 mg/kg
0
Number of Participants With Clinically Significant Change in Vital Sign MeasurementsPrimary· 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.
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
0
Cohort 2: E6011 5 mg/kg
0
Cohort 3: E6011 10 mg/kg
0
Cohort 4: E6011 15 mg/kg
0
Number of Participants With Treatment-emergent Clinically Significant Abnormal Electrocardiogram (ECG) FindingsPrimary· 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.
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
0
Cohort 2: E6011 5 mg/kg
0
Cohort 3: E6011 10 mg/kg
0
Cohort 4: E6011 15 mg/kg
0
Number of Participants With Abnormal Chest X-ray FindingsPrimary· Baseline up to Week 52
Number of participants with abnormal chest X-ray findings were reported.
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
0
Cohort 2: E6011 5 mg/kg
0
Cohort 3: E6011 10 mg/kg
0
Cohort 4: E6011 15 mg/kg
0
Number of Participants With Neurological FindingsPrimary· Baseline up to Week 52
Number of participants with neurological findings were reported.
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
0
Cohort 2: E6011 5 mg/kg
0
Cohort 3: E6011 10 mg/kg
0
Cohort 4: E6011 15 mg/kg
0
Mean Trough Serum Concentration of E6011 at Week 12 and 52Secondary· Week 12: Pre-dose; Week 52: Pre-dose
Week 12
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
3.40
± 3.74
Cohort 2: E6011 5 mg/kg
26.1
± 10.4
Cohort 3: E6011 10 mg/kg
96.8
± 60.3
Cohort 4: E6011 15 mg/kg
146
± 91.9
Week 52
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
10.8
± NA
Cohort 2: E6011 5 mg/kg
17.3
± 2.90
Cohort 3: E6011 10 mg/kg
105
± 9.69
Cohort 4: E6011 15 mg/kg
93.9
± 46.8
Number of Participants With Serum Anti-E6011 Antibody at Week 12 and 52Secondary· At Week 12 and Week 52
Number of participants with serum anti-E6011 antibody were reported.
Week 12
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
4
Cohort 2: E6011 5 mg/kg
3
Cohort 3: E6011 10 mg/kg
2
Cohort 4: E6011 15 mg/kg
1
Week 52
Group
Value
95% CI
Cohort 1: E6011 2 mg/kg
4
Cohort 2: E6011 5 mg/kg
3
Cohort 3: E6011 10 mg/kg
2
Cohort 4: E6011 15 mg/kg
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Week 62 (70 days after last dose of study drug).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EA Pharma Co., Ltd.
Last refreshed: 30 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02039063.