A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis

Study Purpose

The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years - 74 Years
Gender All
More Inclusion & Exclusion Criteria

Major

Inclusion Criteria:

1. Participants diagnosed with ulcerative colitis. 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. Major

Exclusion Criteria:

1. Participants with extensive detachment of mucosa or deep ulcer. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03531892
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

EA Pharma Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Arms & Interventions

Arms

Experimental: AJM300 960mg/dose

Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks.

Placebo Comparator: Placebo

Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks.

Interventions

Drug: - AJM300

AJM300 film-coated tablets.

Drug: - Placebo

Placebo matched to AJM300 tablets.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

AJM300/CT3 trial site 41, Nagoya, Aichi, Japan

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AJM300/CT3 trial site 41

Nagoya, Aichi,

AJM300/CT3 trial site 57, Nagoya, Aichi, Japan

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AJM300/CT3 trial site 57

Nagoya, Aichi,

AJM300/CT3 trial site 63, Nagoya, Aichi, Japan

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AJM300/CT3 trial site 63

Nagoya, Aichi,

AJM300/CT3 trial site 9, Toyoake, Aichi, Japan

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AJM300/CT3 trial site 9

Toyoake, Aichi,

AJM300/CT3 trial site 33, Toyohashi, Aichi, Japan

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AJM300/CT3 trial site 33

Toyohashi, Aichi,

AJM300/CT3 trial site 42, Toyota, Aichi, Japan

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AJM300/CT3 trial site 42

Toyota, Aichi,

AJM300/CT3 trial site 39, Hirosaki, Aomori, Japan

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AJM300/CT3 trial site 39

Hirosaki, Aomori,

AJM300/CT3 trial site 49, Hirosaki, Aomori, Japan

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AJM300/CT3 trial site 49

Hirosaki, Aomori,

AJM300/CT3 trial site 11, Kashiwa, Chiba, Japan

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AJM300/CT3 trial site 11

Kashiwa, Chiba,

AJM300/CT3 trial site 51, Kashiwa, Chiba, Japan

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AJM300/CT3 trial site 51

Kashiwa, Chiba,

AJM300/CT3 trial site 73, Sakura, Chiba, Japan

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AJM300/CT3 trial site 73

Sakura, Chiba,

AJM300/CT3 trial site 54, Urayasu, Chiba, Japan

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AJM300/CT3 trial site 54

Urayasu, Chiba,

AJM300/CT3 trial site 81, Matsuyama, Ehime, Japan

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AJM300/CT3 trial site 81

Matsuyama, Ehime,

AJM300/CT3 trial site 53, Kurume, Fukuoka, Japan

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AJM300/CT3 trial site 53

Kurume, Fukuoka,

AJM300/CT3 trial site 24, Tikushino, Fukuoka, Japan

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AJM300/CT3 trial site 24

Tikushino, Fukuoka,

AJM300/CT3 trial site 55, Isesaki, Gunma, Japan

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AJM300/CT3 trial site 55

Isesaki, Gunma,

AJM300/CT3 trial site 35, Fukuyama, Hiroshima, Japan

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AJM300/CT3 trial site 35

Fukuyama, Hiroshima,

AJM300/CT3 trial site 18, Asahikawa, Hokkaido, Japan

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AJM300/CT3 trial site 18

Asahikawa, Hokkaido,

AJM300/CT3 trial site 26, Asahikawa, Hokkaido, Japan

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AJM300/CT3 trial site 26

Asahikawa, Hokkaido,

AJM300/CT3 trial site 2, Sapporo, Hokkaido, Japan

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AJM300/CT3 trial site 2

Sapporo, Hokkaido,

AJM300/CT3 trial site 3, Sapporo, Hokkaido, Japan

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AJM300/CT3 trial site 3

Sapporo, Hokkaido,

AJM300/CT3 trial site 4, Sapporo, Hokkaido, Japan

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AJM300/CT3 trial site 4

Sapporo, Hokkaido,

AJM300/CT3 trial site 79, Akashi, Hyogo, Japan

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AJM300/CT3 trial site 79

Akashi, Hyogo,

AJM300/CT3 trial site 34, Kobe, Hyogo, Japan

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AJM300/CT3 trial site 34

Kobe, Hyogo,

AJM300/CT3 trial site 64, Nishinomiya, Hyogo, Japan

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AJM300/CT3 trial site 64

Nishinomiya, Hyogo,

AJM300/CT3 trial site 82, Kasama, Ibaraki, Japan

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AJM300/CT3 trial site 82

Kasama, Ibaraki,

AJM300/CT3 trial site 75, Tsukuba, Ibaraki, Japan

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AJM300/CT3 trial site 75

Tsukuba, Ibaraki,

AJM300/CT3 trial site 19, Morioka, Iwate, Japan

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AJM300/CT3 trial site 19

Morioka, Iwate,

AJM300/CT3 trial site 16, Takamatsu, Kagawa, Japan

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AJM300/CT3 trial site 16

Takamatsu, Kagawa,

AJM300/CT3 trial site 12, Kamakura, Kanagawa, Japan

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AJM300/CT3 trial site 12

Kamakura, Kanagawa,

AJM300/CT3 trial site 14, Sagamihara, Kanagawa, Japan

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AJM300/CT3 trial site 14

Sagamihara, Kanagawa,

AJM300/CT3 trial site 32, Sagamihara, Kanagawa, Japan

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AJM300/CT3 trial site 32

Sagamihara, Kanagawa,

AJM300/CT3 trial site 13, Yokohama, Kanagawa, Japan

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AJM300/CT3 trial site 13

Yokohama, Kanagawa,

AJM300/CT3 trial site 6, Yokohama, Kanagawa, Japan

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AJM300/CT3 trial site 6

Yokohama, Kanagawa,

AJM300/CT3 trial site 47, Tsu, Mie, Japan

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AJM300/CT3 trial site 47

Tsu, Mie,

AJM300/CT3 trial site 46, Yokkaichi, Mie, Japan

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AJM300/CT3 trial site 46

Yokkaichi, Mie,

AJM300/CT3 trial site 45, Sendai, Miyagi, Japan

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AJM300/CT3 trial site 45

Sendai, Miyagi,

AJM300/CT3 trial site 50, Sendai, Miyagi, Japan

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AJM300/CT3 trial site 50

Sendai, Miyagi,

AJM300/CT3 trial site 78, Sendai, Miyagi, Japan

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AJM300/CT3 trial site 78

Sendai, Miyagi,

AJM300/CT3 trial site 22, Nagaoka, Nigata, Japan

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AJM300/CT3 trial site 22

Nagaoka, Nigata,

AJM300/CT3 trial site 15, Kurashiki, Okayama, Japan

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AJM300/CT3 trial site 15

Kurashiki, Okayama,

AJM300/CT3 trial site 70, Kurashiki, Okayama, Japan

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AJM300/CT3 trial site 70

Kurashiki, Okayama,

AJM300/CT3 trial site 77, Higashiosaka, Osaka, Japan

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AJM300/CT3 trial site 77

Higashiosaka, Osaka,

AJM300/CT3 trial site 76, Osakasayama, Osaka, Japan

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AJM300/CT3 trial site 76

Osakasayama, Osaka,

AJM300/CT3 trial site 10, Takatsuki, Osaka, Japan

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AJM300/CT3 trial site 10

Takatsuki, Osaka,

AJM300/CT3 trial site 40, Ageo, Saitama, Japan

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AJM300/CT3 trial site 40

Ageo, Saitama,

AJM300/CT3 trial site 5, Ageo, Saitama, Japan

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AJM300/CT3 trial site 5

Ageo, Saitama,

AJM300/CT3 trial site 72, Tokorozawa, Saitama, Japan

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AJM300/CT3 trial site 72

Tokorozawa, Saitama,

AJM300/CT3 trial site 17, Hamamatsu, Shizuoka, Japan

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AJM300/CT3 trial site 17

Hamamatsu, Shizuoka,

AJM300/CT3 trial site 60, Ashikaga, Tochigi, Japan

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AJM300/CT3 trial site 60

Ashikaga, Tochigi,

AJM300/CT3 trial site 29, Shimotsuga, Tochigi, Japan

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AJM300/CT3 trial site 29

Shimotsuga, Tochigi,

AJM300/CT3 trial site 71, Utsunomiya, Tochigi, Japan

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AJM300/CT3 trial site 71

Utsunomiya, Tochigi,

AJM300/CT3 trial site 61, Bunkyo, Tokyo, Japan

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AJM300/CT3 trial site 61

Bunkyo, Tokyo,

AJM300/CT3 trial site 68, Bunkyo, Tokyo, Japan

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AJM300/CT3 trial site 68

Bunkyo, Tokyo,

AJM300/CT3 trial site 59, Chiyoda, Tokyo, Japan

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AJM300/CT3 trial site 59

Chiyoda, Tokyo,

AJM300/CT3 trial site 30, Chuo, Tokyo, Japan

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AJM300/CT3 trial site 30

Chuo, Tokyo,

AJM300/CT3 trial site 31, Hachioji, Tokyo, Japan

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AJM300/CT3 trial site 31

Hachioji, Tokyo,

AJM300/CT3 trial site 56, Minato, Tokyo, Japan

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AJM300/CT3 trial site 56

Minato, Tokyo,

AJM300/CT3 trial site 66, Minato, Tokyo, Japan

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AJM300/CT3 trial site 66

Minato, Tokyo,

AJM300/CT3 trial site 80, Mitaka, Tokyo, Japan

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AJM300/CT3 trial site 80

Mitaka, Tokyo,

AJM300/CT3 trial site 38, Shinagawa, Tokyo, Japan

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AJM300/CT3 trial site 38

Shinagawa, Tokyo,

AJM300/CT3 trial site 21, Shinjuku, Tokyo, Japan

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AJM300/CT3 trial site 21

Shinjuku, Tokyo,

AJM300/CT3 trial site 52, Shinjuku, Tokyo, Japan

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AJM300/CT3 trial site 52

Shinjuku, Tokyo,

AJM300/CT3 trial site 8, Shūnan, Yamaguchi, Japan

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AJM300/CT3 trial site 8

Shūnan, Yamaguchi,

AJM300/CT3 trial site 23, Kofu, Yamanashi, Japan

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Recruiting

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AJM300/CT3 trial site 23

Kofu, Yamanashi,

AJM300/CT3 trial site 44, Chiba, Japan

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Recruiting

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AJM300/CT3 trial site 44

Chiba, ,

AJM300/CT3 trial site 43, Fukuoka, Japan

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AJM300/CT3 trial site 43

Fukuoka, ,

AJM300/CT3 trial site 58, Fukuoka, Japan

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AJM300/CT3 trial site 58

Fukuoka, ,

AJM300/CT3 trial site 69, Fukuoka, Japan

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AJM300/CT3 trial site 69

Fukuoka, ,

AJM300/CT3 trial site 67, Gifu, Japan

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AJM300/CT3 trial site 67

Gifu, ,

AJM300/CT3 trial site 28, Hiroshima, Japan

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AJM300/CT3 trial site 28

Hiroshima, ,

AJM300/CT3 trial site 36, Hiroshima, Japan

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AJM300/CT3 trial site 36

Hiroshima, ,

AJM300/CT3 trial site 74, Hiroshima, Japan

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AJM300/CT3 trial site 74

Hiroshima, ,

AJM300/CT3 trial site 62, Kyoto, Japan

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AJM300/CT3 trial site 62

Kyoto, ,

AJM300/CT3 trial site 7, Kyoto, Japan

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AJM300/CT3 trial site 7

Kyoto, ,

AJM300/CT3 trial site 48, Nagasaki, Japan

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AJM300/CT3 trial site 48

Nagasaki, ,

AJM300/CT3 trial site 37, Oita, Japan

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AJM300/CT3 trial site 37

Oita, ,

AJM300/CT3 trial site 65, Okayama, Japan

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AJM300/CT3 trial site 65

Okayama, ,

AJM300/CT3 trial site 1, Osaka, Japan

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AJM300/CT3 trial site 1

Osaka, ,

AJM300/CT3 trial site 20, Saga, Japan

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AJM300/CT3 trial site 20

Saga, ,

AJM300/CT3 trial site 25, Saga, Japan

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AJM300/CT3 trial site 25

Saga, ,

AJM300/CT3 trial site 27, Toyama, Japan

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Recruiting

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AJM300/CT3 trial site 27

Toyama, ,

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