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| ID | Type | Description | Link |
|---|---|---|---|
| 142543 | Other Identifier | JapicCTI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | E6011 2 mg/kg |
|
| 2 | Experimental | E6011 5 mg/kg |
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| 3 | Experimental | E6011 10 mg/kg |
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| 4 | Experimental | E6011 15 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E6011 2 mg/kg | Drug |
| ||
| E6011 5 mg/kg |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Trough Serum Concentration of E6011 at Week 12 and 52 | 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. |
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Inclusion Criteria
Subjects must meet all of the following criteria to be included in this study:
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33599356 | Result | 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. |
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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.
Participants took part in the study at 22 investigative sites in Japan from 05 April 2014 to 27 November 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
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|
| E6011 10 mg/kg | Drug |
|
| E6011 15 mg/kg | Drug |
|
| 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. | Baseline up to Week 52 |
| Number of Participants With Neurological Findings | Number of participants with neurological findings were reported. | Baseline up to Week 52 |
| At Week 12 and Week 52 |
| Chikushino-shi |
| Fukuoka |
| Japan |
| Kurume | Fukuoka | Japan |
| Asahikawa | Hokkaido | Japan |
| Nishinomiya | Hyōgo | Japan |
| Kanazawa | Ishikawa-ken | Japan |
| Morioka | Iwate | Japan |
| Sagamihara | Kanagawa | Japan |
| Tsu | Mie-ken | Japan |
| Urazoe | Okinawa | Japan |
| Takatsuki | Osaka | Japan |
| Minato-ku | Tokyo | Japan |
| Shinjuku-ku | Tokyo | Japan |
| Chiba | Japan |
| Fukuoka | Japan |
| Kyoto | Japan |
| Osaka | Japan |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Phase |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: E6011 2 mg/kg | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Baseline up to Week 62 (70 days after last dose of study drug) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Chest X-ray Findings | Number of participants with abnormal chest X-ray findings were reported. | 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. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Neurological Findings | Number of participants with neurological findings were reported. | The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Trough Serum Concentration of E6011 at Week 12 and 52 | 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. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Week 12: Pre-dose; Week 52: Pre-dose |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serum Anti-E6011 Antibody at Week 12 and 52 | Number of participants with serum anti-E6011 antibody were reported. | 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. | Posted | Count of Participants | Participants | At Week 12 and Week 52 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: E6011 2 mg/kg | 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. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG001 | 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. | 0 | 8 | 1 | 8 | 6 | 8 |
| EG002 | 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. | 0 | 7 | 5 | 7 | 7 | 7 |
| EG003 | 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. | 0 | 7 | 0 | 7 | 3 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Miscarriage of partner | Social circumstances | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyperaemia | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corporate Communication Dept. | EA Pharma Co., Ltd | +81-(0)3-6280-9600 | contact_ea@eapharma.co.jp |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627635 | quetmolimab |
Not provided
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| Progression of disease |
|
| Adverse Event |
|
| Male |
|
| SAE |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
| OG002 |
| 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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
| Title | Measurements |
|---|---|
|