A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
NCT ID: NCT03531892
Last Updated: 2023-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
198 participants
INTERVENTIONAL
2018-06-06
2023-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AJM300 960mg/dose
Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks.
AJM300
AJM300 film-coated tablets.
Placebo
Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks.
Placebo
Placebo matched to AJM300 tablets.
Interventions
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AJM300
AJM300 film-coated tablets.
Placebo
Placebo matched to AJM300 tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants with moderate ulcerative colitis who satisfy all of the following criteria at Day of enrollment.
1. Mayo Clinic scores of 6-10 .
2. Endoscopic subscore greater than or equal to (\>=) 2.
3. Rectal bleeding subscore \>=1.
3. Participants with inadequate response or intolerant to oral 5-ASA
4. Participants who are capable of providing written informed consent
Exclusion Criteria
2. Participants with oral corticosteroid dependency.
3. Participants with a complication of marked reduction of immune function.
4. Participants who were clinically suspected to have a complication of infectious enteritis.
5. Participants with a history or complication of serious infection within 1 year prior to the day of enrollment.
6. Participants with central nervous system (CNS) neurological symptoms.
7. Participants with the following criteria:
* Serious heart disease
* Renal impairment
* Hepatic impairment
8. Participants with a history of serious drug induced allergy with unknown cause.
9. Participants with malignant tumor or those whose treatments were completed in less than 5 years.
10. Participants with apparent psychological signs.
11. Pregnant women, nursing women, women with suspected pregnancy, women who wish to become pregnant during the period from informed consent through to the end of observation/examination at Week 8, and women who do not consent to the use of appropriate birth control methods.
12. Participants who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc.
13. Participants who are participants of another clinical study including follow-up observation at the time of informed consent.
14. Participants who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol.
15. Participants who received investigational drugs in the study of AJM300.
16. Participants determined to be ineligible for participation in this study by the investigator or sub-investigator.
16 Years
74 Years
ALL
No
Sponsors
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Kissei Pharmaceutical Co., Ltd.
INDUSTRY
EA Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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AJM300/CT3 trial site 41
Nagoya, Aichi-ken, Japan
AJM300/CT3 trial site 57
Nagoya, Aichi-ken, Japan
AJM300/CT3 trial site 63
Nagoya, Aichi-ken, Japan
AJM300/CT3 trial site 9
Toyoake, Aichi-ken, Japan
AJM300/CT3 trial site 33
Toyohashi, Aichi-ken, Japan
AJM300/CT3 trial site 42
Toyota, Aichi-ken, Japan
AJM300/CT3 trial site 39
Hirosaki, Aomori, Japan
AJM300/CT3 trial site 49
Hirosaki, Aomori, Japan
AJM300/CT3 trial site 11
Kashiwa, Chiba, Japan
AJM300/CT3 trial site 51
Kashiwa, Chiba, Japan
AJM300/CT3 trial site 73
Sakura, Chiba, Japan
AJM300/CT3 trial site 54
Urayasu, Chiba, Japan
AJM300/CT3 trial site 81
Matsuyama, Ehime, Japan
AJM300/CT3 trial site 53
Kurume, Fukuoka, Japan
AJM300/CT3 trial site 24
Tikushino, Fukuoka, Japan
AJM300/CT3 trial site 55
Isesaki, Gunma, Japan
AJM300/CT3 trial site 35
Fukuyama, Hiroshima, Japan
AJM300/CT3 trial site 18
Asahikawa, Hokkaido, Japan
AJM300/CT3 trial site 26
Asahikawa, Hokkaido, Japan
AJM300/CT3 trial site 2
Sapporo, Hokkaido, Japan
AJM300/CT3 trial site 3
Sapporo, Hokkaido, Japan
AJM300/CT3 trial site 4
Sapporo, Hokkaido, Japan
AJM300/CT3 trial site 79
Akashi, Hyōgo, Japan
AJM300/CT3 trial site 34
Kobe, Hyōgo, Japan
AJM300/CT3 trial site 64
Nishinomiya, Hyōgo, Japan
AJM300/CT3 trial site 82
Kasama, Ibaraki, Japan
AJM300/CT3 trial site 75
Tsukuba, Ibaraki, Japan
AJM300/CT3 trial site 19
Morioka, Iwate, Japan
AJM300/CT3 trial site 16
Takamatsu, Kagawa-ken, Japan
AJM300/CT3 trial site 12
Kamakura, Kanagawa, Japan
AJM300/CT3 trial site 14
Sagamihara, Kanagawa, Japan
AJM300/CT3 trial site 32
Sagamihara, Kanagawa, Japan
AJM300/CT3 trial site 13
Yokohama, Kanagawa, Japan
AJM300/CT3 trial site 6
Yokohama, Kanagawa, Japan
AJM300/CT3 trial site 47
Tsu, Mie-ken, Japan
AJM300/CT3 trial site 46
Yokkaichi, Mie-ken, Japan
AJM300/CT3 trial site 45
Sendai, Miyagi, Japan
AJM300/CT3 trial site 50
Sendai, Miyagi, Japan
AJM300/CT3 trial site 78
Sendai, Miyagi, Japan
AJM300/CT3 trial site 22
Nagaoka, Niigata, Japan
AJM300/CT3 trial site 15
Kurashiki, Okayama-ken, Japan
AJM300/CT3 trial site 70
Kurashiki, Okayama-ken, Japan
AJM300/CT3 trial site 77
Higashiosaka, Osaka, Japan
AJM300/CT3 trial site 76
Sayama, Osaka, Japan
AJM300/CT3 trial site 10
Takatsuki, Osaka, Japan
AJM300/CT3 trial site 40
Ageo, Saitama, Japan
AJM300/CT3 trial site 5
Ageo, Saitama, Japan
AJM300/CT3 trial site 72
Tokorozawa, Saitama, Japan
AJM300/CT3 trial site 17
Hamamatsu, Shizuoka, Japan
AJM300/CT3 trial site 60
Ashikaga, Tochigi, Japan
AJM300/CT3 trial site 29
Shimotsuga, Tochigi, Japan
AJM300/CT3 trial site 71
Utsunomiya, Tochigi, Japan
AJM300/CT3 trial site 61
Bunkyo, Tokyo, Japan
AJM300/CT3 trial site 68
Bunkyo, Tokyo, Japan
AJM300/CT3 trial site 59
Chiyoda City, Tokyo, Japan
AJM300/CT3 trial site 30
Chūō, Tokyo, Japan
AJM300/CT3 trial site 31
Hachiōji, Tokyo, Japan
AJM300/CT3 trial site 56
Minato, Tokyo, Japan
AJM300/CT3 trial site 66
Minato, Tokyo, Japan
AJM300/CT3 trial site 80
Mitaka, Tokyo, Japan
AJM300/CT3 trial site 38
Shinagawa, Tokyo, Japan
AJM300/CT3 trial site 21
Shinjuku, Tokyo, Japan
AJM300/CT3 trial site 52
Shinjuku, Tokyo, Japan
AJM300/CT3 trial site 8
Shūnan, Yamaguchi, Japan
AJM300/CT3 trial site 23
Kofu, Yamanashi, Japan
AJM300/CT3 trial site 44
Chiba, , Japan
AJM300/CT3 trial site 43
Fukuoka, , Japan
AJM300/CT3 trial site 58
Fukuoka, , Japan
AJM300/CT3 trial site 69
Fukuoka, , Japan
AJM300/CT3 trial site 67
Gifu, , Japan
AJM300/CT3 trial site 28
Hiroshima, , Japan
AJM300/CT3 trial site 36
Hiroshima, , Japan
AJM300/CT3 trial site 74
Hiroshima, , Japan
AJM300/CT3 trial site 62
Kyoto, , Japan
AJM300/CT3 trial site 7
Kyoto, , Japan
AJM300/CT3 trial site 48
Nagasaki, , Japan
AJM300/CT3 trial site 65
Okayama, , Japan
AJM300/CT3 trial site 1
Osaka, , Japan
AJM300/CT3 trial site 37
Ōita, , Japan
AJM300/CT3 trial site 20
Saga, , Japan
AJM300/CT3 trial site 25
Saga, , Japan
AJM300/CT3 trial site 27
Toyama, , Japan
Countries
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References
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Matsuoka K, Watanabe M, Ohmori T, Nakajima K, Ishida T, Ishiguro Y, Kanke K, Kobayashi K, Hirai F, Watanabe K, Mizusawa H, Kishida S, Miura Y, Ohta A, Kajioka T, Hibi T; AJM300 Study Group. AJM300 (carotegrast methyl), an oral antagonist of alpha4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Jul;7(7):648-657. doi: 10.1016/S2468-1253(22)00022-X. Epub 2022 Mar 30.
Other Identifiers
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JapicCTI-183924
Identifier Type: REGISTRY
Identifier Source: secondary_id
AJM300/CT3
Identifier Type: -
Identifier Source: org_study_id
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