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This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI7183 dose 1 | Experimental | Double blinded |
|
| MEDI7183 dose 2 | Experimental | Double blinded |
|
| MEDI7183 dose 3 | Experimental | Double blinded |
|
| Placebo | Placebo Comparator | Double blinded |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI7183 low dose | Drug | MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Remission at Week 8 | Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response at Week 8 | Response at Week 8 was assessed by total Mayo score. Response was defined as decrease 3 points or more and 30 percents in total Mayo score compared to baseline, and with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or with an absolute subscore for rectal bleeding of 0 or 1. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshifumi Hibi, Director and Professor | Centre for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University | Principal Investigator |
| Ki Rito, Study Physician | AztraZeneca, Tokyo, Japan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chikushino-shi | 818-8502 | Japan | |||
| Research Site |
Out of the 59 enrolled participants, 14 participapatients were not assigned to any arm. Out of these 14 participants, 13 participants did not meet the eligibility criteria and 1 participants withdrew the informed consent.
In the protocol part, the number of enrolled participants was 44. This number means 44 participants who were assigned and received the treatment. In fact, 59 participants signed informed consent form. Out of the enrolled, 45 participants were assigned, and 1 out of the 45 participants discontinued the study without receiving any treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo double blind phase |
| FG001 | MEDI7183 21 mg | MEDI7183 21 mg double blind phase |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MEDI7183 medium dose |
| Drug |
MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 |
|
| MEDI7183 high dose | Drug | MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8 |
|
| Matching Placebo | Drug | Placebo will be administered by SC on Day 1, Week 2,4, and 8 |
|
| Number of Participants With Mucosal Healing at Week 8 | Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1. | 8 weeks |
| Number of Participants With Response at Week 12 | Response at Week 12 was assessed by Partial Mayo Score. Response was defined as reduction by 2 or more points and 25% in Partial Mayo Score compared to baseline. | 12 weeks |
| Fujiidera-shi |
| 583-0027 |
| Japan |
| Research Site | Fukuyama-shi | 720-8520 | Japan |
| Research Site | Hamamatsu | 432-8061 | Japan |
| Research Site | Kagoshima | 892-0846 | Japan |
| Research Site | Kamakura-shi | 247-0056 | Japan |
| Research Site | Kyoto | 606-8507 | Japan |
| Research Site | Kyoto | 612-8555 | Japan |
| Research Site | Minatoku | 108-8642 | Japan |
| Research Site | Morioka | 020-8505 | Japan |
| Research Site | Niigata | 950-1104 | Japan |
| Research Site | Nishinomiya-shi | 663-8501 | Japan |
| Research Site | Osaka | 545-8586 | Japan |
| Research Site | ÅŒita | 870-0033 | Japan |
| Research Site | Sakura-shi | 285-8741 | Japan |
| Research Site | Sapporo | 004-0041 | Japan |
| Research Site | Sapporo | 060-0033 | Japan |
| Research Site | Sapporo | 065-0033 | Japan |
| Research Site | Sayama-shi | 350-1305 | Japan |
| Research Site | Shinagawa-ku | 141-0022 | Japan |
| Research Site | Shinjuku-ku | 169-0073 | Japan |
| Research Site | Yokkaichi-shi | 510-0016 | Japan |
| Research Site | Yokohama | 236-0004 | Japan |
| FG002 |
| MEDI7183 70 mg |
MEDI7183 70 mg double blind phase |
| FG003 | MEDI7183 210 mg | MEDI7183 210 mg double blind phase |
| COMPLETED | completed patients number in double blind period |
|
| NOT COMPLETED |
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In MEDI7183 21 mg arm, 11 patients were randomised, but 1 patient discontinued the study without any treatment. Therefore, this patient was excluded from all of the analyses in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo double blind phase |
| BG001 | MEDI7183 21 mg | MEDI7183 21 mg double blind phase |
| BG002 | MEDI7183 70 mg | MEDI7183 70 mg double blind phase |
| BG003 | MEDI7183 210 mg | MEDI7183 210 mg double blind phase |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| duration of Ulcerative Colitis | Mean | Full Range | years |
| |||||||||||||||
| use of 5-aminosalicylates | use of 5-aminosalicylates at baseline of double-blind phase | Count of Participants | Participants |
| |||||||||||||||
| use of oral corticosteroids | use of oral corticosteroids at baseline of double blind phase | Count of Participants | Participants |
| |||||||||||||||
| use of immunomodulators | use of immunomodulators at baseline of double blind phase | Count of Participants | Participants |
| |||||||||||||||
| any prior use of anti-TNF-a agents | 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 Remission at Week 8 | Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point. | All randomised participants who received at least one dose of investigational drug during the double-blind phase | Posted | Count of Participants | Participants | 8 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response at Week 8 | Response at Week 8 was assessed by total Mayo score. Response was defined as decrease 3 points or more and 30 percents in total Mayo score compared to baseline, and with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or with an absolute subscore for rectal bleeding of 0 or 1. | All randomised participants who received at least one dose of investigational drug during the double-blind phase | Posted | Count of Participants | Participants | 8 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Mucosal Healing at Week 8 | Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1. | All randomised participants who received at least one dose of investigational drug during the double-blind phase | Posted | Count of Participants | Participants | 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response at Week 12 | Response at Week 12 was assessed by Partial Mayo Score. Response was defined as reduction by 2 or more points and 25% in Partial Mayo Score compared to baseline. | All randomised participants who received at least one dose of investigational drug during the double-blind phase | Posted | Count of Participants | Participants | 12 weeks |
|
|
12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo double blind period | 0 | 13 | 0 | 13 | 9 | 13 |
| EG001 | MEDI7183 21 mg | MEDI7183 21 mg double blind phase | 0 | 10 | 1 | 10 | 6 | 10 |
| EG002 | MEDI7183 70 mg | MEDI7183 70 mg double blind period | 0 | 12 | 0 | 12 | 6 | 12 |
| EG003 | MEDI7183 210 mg | MEDI7183 210 mg double blind period | 0 | 9 | 1 | 9 | 3 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| colitis ulcerative | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| cerebral infarction | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment | No other AEs were observed in the subject suffered this SAE. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| colitis ulcerative | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| proctalgia | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| malaise | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| enterocolitis viral | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| xeroderma | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| contusion | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| gingivitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| injection site swelling | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| blood creatine phosphokinase increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| weight decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| white blood cell count decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| skin swelling | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| lymph node pain | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| cataract | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| dry eye | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| visual impairment | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| tooth fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nii Masahiro | Biometrics | +81 6 7711 4571 | 4571 | Masahiro.Nii@astrazeneca.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000591337 | abrilumab |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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