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

NCT03531892 | Completed Phase 3

• 2 other identifiers: AJM300/CT3JapicCTI-183924
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 82

Brief Summary

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.

Conditions

Colitis, Ulcerative

Keywords

Ulcerative Colitis; Inflammatory Bowel Disease, Ulcerative Colitis Type; Colitis; AJM300

Outcome Measures

Primary Outcomes (1)

• Clinical Response Rate Based on Mayo Score

  Clinical response rate is defined by the percentage of participants who satisfy the combined definition of the change of the total value of Mayo score and the change or the actual value of individual subscales. Mayo score is used in clinical trials to assess ulcerative colitis (UC) disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.

  At Week 8

Secondary Outcomes (12)

• Clinical Remission Rate Based on Mayo Score

  At Week 8

• Mucosal Healing Rate

  At Week 8

• Complete Mucosal Healing Rate

  At Week 8

• Clinical Response Rate Based on Partial Mayo Score

  At Week 8

• Clinical Remission Rate Based on Partial Mayo Score

  At Week 8

Study Arms (2)

AJM300 960mg/dose

EXPERIMENTAL

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

Drug: AJM300

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AJM300 DRUG

AJM300 film-coated tablets.

Also known as: Carotegrast methyl

AJM300 960mg/dose

Placebo DRUG

Placebo matched to AJM300 tablets.

Placebo

Eligibility Criteria

• Age: 16 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with ulcerative colitis.
• Participants with moderate ulcerative colitis who satisfy all of the following criteria at Day of enrollment.
• Mayo Clinic scores of 6-10 .
• Endoscopic subscore greater than or equal to (\>=) 2.
• Rectal bleeding subscore \>=1.
• Participants with inadequate response or intolerant to oral 5-ASA
• Participants who are capable of providing written informed consent

You may not qualify if:

• Participants with extensive detachment of mucosa or deep ulcer.
• Participants with oral corticosteroid dependency.
• Participants with a complication of marked reduction of immune function.
• Participants who were clinically suspected to have a complication of infectious enteritis.
• Participants with a history or complication of serious infection within 1 year prior to the day of enrollment.
• Participants with central nervous system (CNS) neurological symptoms.
• Participants with the following criteria:
• Serious heart disease
• Renal impairment
• Hepatic impairment
• Participants with a history of serious drug induced allergy with unknown cause.
• Participants with malignant tumor or those whose treatments were completed in less than 5 years.
• Participants with apparent psychological signs.
• 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.
• Participants who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc.

Sponsors & Collaborators

• EA Pharma Co., Ltd.: lead
• Kissei Pharmaceutical Co., Ltd.: collaborator

Study Sites (82)

AJM300/CT3 trial site 41

Nagoya, Aichi-ken, Japan

Location

AJM300/CT3 trial site 57

Nagoya, Aichi-ken, Japan

Location

AJM300/CT3 trial site 63

Nagoya, Aichi-ken, Japan

Location

AJM300/CT3 trial site 9

Toyoake, Aichi-ken, Japan

Location

AJM300/CT3 trial site 33

Toyohashi, Aichi-ken, Japan

Location

AJM300/CT3 trial site 42

Toyota, Aichi-ken, Japan

Location

AJM300/CT3 trial site 39

Hirosaki, Aomori, Japan

Location

AJM300/CT3 trial site 49

Hirosaki, Aomori, Japan

Location

AJM300/CT3 trial site 11

Kashiwa, Chiba, Japan

Location

AJM300/CT3 trial site 51

Kashiwa, Chiba, Japan

Location

AJM300/CT3 trial site 73

Sakura, Chiba, Japan

Location

AJM300/CT3 trial site 54

Urayasu, Chiba, Japan

Location

AJM300/CT3 trial site 81

Matsuyama, Ehime, Japan

Location

AJM300/CT3 trial site 53

Kurume, Fukuoka, Japan

Location

AJM300/CT3 trial site 24

Tikushino, Fukuoka, Japan

Location

AJM300/CT3 trial site 55

Isesaki, Gunma, Japan

Location

AJM300/CT3 trial site 35

Fukuyama, Hiroshima, Japan

Location

AJM300/CT3 trial site 18

Asahikawa, Hokkaido, Japan

Location

AJM300/CT3 trial site 26

Asahikawa, Hokkaido, Japan

Location

AJM300/CT3 trial site 2

Sapporo, Hokkaido, Japan

Location

AJM300/CT3 trial site 3

Sapporo, Hokkaido, Japan

Location

AJM300/CT3 trial site 4

Sapporo, Hokkaido, Japan

Location

AJM300/CT3 trial site 79

Akashi, Hyōgo, Japan

Location

AJM300/CT3 trial site 34

Kobe, Hyōgo, Japan

Location

AJM300/CT3 trial site 64

Nishinomiya, Hyōgo, Japan

Location

AJM300/CT3 trial site 82

Kasama, Ibaraki, Japan

Location

AJM300/CT3 trial site 75

Tsukuba, Ibaraki, Japan

Location

AJM300/CT3 trial site 19

Morioka, Iwate, Japan

Location

AJM300/CT3 trial site 16

Takamatsu, Kagawa-ken, Japan

Location

AJM300/CT3 trial site 12

Kamakura, Kanagawa, Japan

Location

AJM300/CT3 trial site 14

Sagamihara, Kanagawa, Japan

Location

AJM300/CT3 trial site 32

Sagamihara, Kanagawa, Japan

Location

AJM300/CT3 trial site 13

Yokohama, Kanagawa, Japan

Location

AJM300/CT3 trial site 6

Yokohama, Kanagawa, Japan

Location

AJM300/CT3 trial site 47

Tsu, Mie-ken, Japan

Location

AJM300/CT3 trial site 46

Yokkaichi, Mie-ken, Japan

Location

AJM300/CT3 trial site 45

Sendai, Miyagi, Japan

Location

AJM300/CT3 trial site 50

Sendai, Miyagi, Japan

Location

AJM300/CT3 trial site 78

Sendai, Miyagi, Japan

Location

AJM300/CT3 trial site 22

Nagaoka, Niigata, Japan

Location

AJM300/CT3 trial site 15

Kurashiki, Okayama-ken, Japan

Location

AJM300/CT3 trial site 70

Kurashiki, Okayama-ken, Japan

Location

AJM300/CT3 trial site 77

Higashiosaka, Osaka, Japan

Location

AJM300/CT3 trial site 76

Sayama, Osaka, Japan

Location

AJM300/CT3 trial site 10

Takatsuki, Osaka, Japan

Location

AJM300/CT3 trial site 40

Ageo, Saitama, Japan

Location

AJM300/CT3 trial site 5

Ageo, Saitama, Japan

Location

AJM300/CT3 trial site 72

Tokorozawa, Saitama, Japan

Location

AJM300/CT3 trial site 17

Hamamatsu, Shizuoka, Japan

Location

AJM300/CT3 trial site 60

Ashikaga, Tochigi, Japan

Location

AJM300/CT3 trial site 29

Shimotsuga, Tochigi, Japan

Location

AJM300/CT3 trial site 71

Utsunomiya, Tochigi, Japan

Location

AJM300/CT3 trial site 61

Bunkyo, Tokyo, Japan

Location

AJM300/CT3 trial site 68

Bunkyo, Tokyo, Japan

Location

AJM300/CT3 trial site 59

Chiyoda City, Tokyo, Japan

Location

AJM300/CT3 trial site 30

Chūō, Tokyo, Japan

Location

AJM300/CT3 trial site 31

Hachiōji, Tokyo, Japan

Location

AJM300/CT3 trial site 56

Minato, Tokyo, Japan

Location

AJM300/CT3 trial site 66

Minato, Tokyo, Japan

Location

AJM300/CT3 trial site 80

Mitaka, Tokyo, Japan

Location

AJM300/CT3 trial site 38

Shinagawa, Tokyo, Japan

Location

AJM300/CT3 trial site 21

Shinjuku, Tokyo, Japan

Location

AJM300/CT3 trial site 52

Shinjuku, Tokyo, Japan

Location

AJM300/CT3 trial site 8

Shūnan, Yamaguchi, Japan

Location

AJM300/CT3 trial site 23

Kofu, Yamanashi, Japan

Location

AJM300/CT3 trial site 44

Chiba, Japan

Location

AJM300/CT3 trial site 43

Fukuoka, Japan

Location

AJM300/CT3 trial site 58

Fukuoka, Japan

Location

AJM300/CT3 trial site 69

Fukuoka, Japan

Location

AJM300/CT3 trial site 67

Gifu, Japan

Location

AJM300/CT3 trial site 28

Hiroshima, Japan

Location

AJM300/CT3 trial site 36

Hiroshima, Japan

Location

AJM300/CT3 trial site 74

Hiroshima, Japan

Location

AJM300/CT3 trial site 62

Kyoto, Japan

Location

AJM300/CT3 trial site 7

Kyoto, Japan

Location

AJM300/CT3 trial site 48

Nagasaki, Japan

Location

AJM300/CT3 trial site 65

Okayama, Japan

Location

AJM300/CT3 trial site 1

Osaka, Japan

Location

AJM300/CT3 trial site 37

Ōita, Japan

Location

AJM300/CT3 trial site 20

Saga, Japan

Location

AJM300/CT3 trial site 25

Saga, Japan

Location

AJM300/CT3 trial site 27

Toyama, Japan

Location

Related Publications (1)

• 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.

  PMID: 35366419 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis

Interventions

AJM300

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: June 6, 2018
• Primary Completion: November 9, 2020
• Study Completion: March 28, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-04

Locations

JP (82)