Trial Outcomes & Findings for A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease (NCT NCT02039063)
NCT ID: NCT02039063
Last Updated: 2023-01-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline up to Week 62 (70 days after last dose of study drug)
Results posted on
2023-01-30
Participant Flow
Participants took part in the study at 22 investigative sites in Japan from 05 April 2014 to 27 November 2017.
A total of 38 participants were screened, of which 10 were screen failures and 28 were enrolled to receive study treatment. As planned, combined data for Treatment Phase and Extension Phase is reported.
Participant milestones
| Measure |
Cohort 1: E6011 2 mg/kg
Participants received E6011 2 milligram per kilogram (mg/kg), intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, crohn's disease activity index (CDAI) was less than (\<) 150 or clinical response (CR) greater than or equal to (\>=) 70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Treatment Phase
STARTED
|
6
|
8
|
7
|
7
|
|
Treatment Phase
COMPLETED
|
3
|
6
|
5
|
5
|
|
Treatment Phase
NOT COMPLETED
|
3
|
2
|
2
|
2
|
|
Extension Phase
STARTED
|
1
|
3
|
5
|
3
|
|
Extension Phase
COMPLETED
|
1
|
2
|
2
|
2
|
|
Extension Phase
NOT COMPLETED
|
0
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: E6011 2 mg/kg
Participants received E6011 2 milligram per kilogram (mg/kg), intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, crohn's disease activity index (CDAI) was less than (\<) 150 or clinical response (CR) greater than or equal to (\>=) 70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Treatment Phase
Inadequate therapeutic effect
|
3
|
2
|
1
|
1
|
|
Treatment Phase
Progression of disease
|
0
|
0
|
1
|
1
|
|
Extension Phase
Inadequate therapeutic effect
|
0
|
1
|
2
|
0
|
|
Extension Phase
Progression of disease
|
0
|
0
|
0
|
1
|
|
Extension Phase
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
Baseline characteristics by cohort
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 7.35 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 12.33 • n=7 Participants
|
39.9 years
STANDARD_DEVIATION 14.79 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 8.16 • n=4 Participants
|
36.8 years
STANDARD_DEVIATION 11.10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 62 (70 days after last dose of study drug)Population: The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
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.
Outcome measures
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE
|
6 Participants
|
6 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAE
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
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.
Outcome measures
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
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.
Outcome measures
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Vital Sign Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Number of participants with treatment-emergent clinically significant abnormal ECG findings which were deemed clinically significant by the investigator were reported.
Outcome measures
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Clinically Significant Abnormal Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Number of participants with abnormal chest X-ray findings were reported.
Outcome measures
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Chest X-ray Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Number of participants with neurological findings were reported.
Outcome measures
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Neurological Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12: Pre-dose; Week 52: Pre-dosePopulation: The pharmacokinetic (PK) analysis set included participants who received at least 1 dose of study drug and had at least 1 serum E6011 concentration data. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here "n" was participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Cohort 1: E6011 2 mg/kg
n=3 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=6 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=5 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=5 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Mean Trough Serum Concentration of E6011 at Week 12 and 52
Week 12
|
3.40 microgram per milliliter (mcg/mL)
Standard Deviation 3.74
|
26.1 microgram per milliliter (mcg/mL)
Standard Deviation 10.4
|
96.8 microgram per milliliter (mcg/mL)
Standard Deviation 60.3
|
146 microgram per milliliter (mcg/mL)
Standard Deviation 91.9
|
|
Mean Trough Serum Concentration of E6011 at Week 12 and 52
Week 52
|
10.8 microgram per milliliter (mcg/mL)
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was analyzed.
|
17.3 microgram per milliliter (mcg/mL)
Standard Deviation 2.90
|
105 microgram per milliliter (mcg/mL)
Standard Deviation 9.69
|
93.9 microgram per milliliter (mcg/mL)
Standard Deviation 46.8
|
SECONDARY outcome
Timeframe: At Week 12 and Week 52Population: The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Number of participants with serum anti-E6011 antibody were reported.
Outcome measures
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 Participants
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 Participants
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 Participants
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 Participants
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Number of Participants With Serum Anti-E6011 Antibody at Week 12 and 52
Week 12
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Serum Anti-E6011 Antibody at Week 12 and 52
Week 52
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Cohort 1: E6011 2 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: E6011 5 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3: E6011 10 mg/kg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 4: E6011 15 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 participants at risk
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 participants at risk
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 participants at risk
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 participants at risk
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
12.5%
1/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
57.1%
4/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Social circumstances
Miscarriage of partner
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
Other adverse events
| Measure |
Cohort 1: E6011 2 mg/kg
n=6 participants at risk
Participants received E6011 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 2 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 2: E6011 5 mg/kg
n=8 participants at risk
Participants received E6011 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks (double dose at Week 0) up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 5 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 3: E6011 10 mg/kg
n=7 participants at risk
Participants received E6011 10 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 10 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
Cohort 4: E6011 15 mg/kg
n=7 participants at risk
Participants received E6011 15 mg/kg, intravenous infusion for 30 minutes, at Week 0, 1, 2 and every 2 weeks up to Week 10 in Treatment Phase. Participants who had no safety concerns, CDAI was \<150 or CR \>=70 and wished to continue with administrations had the opportunity to continue in the Extension Phase to receive 15 mg/kg, intravenous infusion for 30 minutes, every 2 weeks from Week 12 up to Week 52.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
12.5%
1/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Eye disorders
Asthenopia
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
12.5%
1/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
12.5%
1/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
General disorders
Malaise
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Anal abscess
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
12.5%
1/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
28.6%
2/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
50.0%
4/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
28.6%
2/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
12.5%
1/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
12.5%
1/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
12.5%
1/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/8 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
14.3%
1/7 • Baseline up to Week 62 (70 days after last dose of study drug)
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place