Clinical trial NCT03531892: A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
Official title: Phase III Study of AJM300 in Patients With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Keywords: Ulcerative Colitis
Inflammatory Bowel Disease, Ulcerative Colitis Type
Colitis
AJM300
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kissei Pharmaceutical Co., Ltd.
First posted: 2018-05-22
Enrollment: 198
Sex: ALL
Minimum age (years): 16
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Clinical Response Rate Based on Mayo Score
timeFrame: At Week 8
Secondary outcomes:
measure: Clinical Remission Rate Based on Mayo Score
timeFrame: At Week 8
measure: Mucosal Healing Rate
timeFrame: At Week 8
measure: Complete Mucosal Healing Rate
timeFrame: At Week 8
measure: Clinical Response Rate Based on Partial Mayo Score
timeFrame: At Week 8
measure: Clinical Remission Rate Based on Partial Mayo Score
timeFrame: At Week 8
measure: Modified Clinical Remission Rate 1
timeFrame: At Week 8
measure: Modified Clinical Remission Rate 2
timeFrame: At Week 8
measure: Percentage of Rectal Bleeding Subscore of 0
timeFrame: At Week 8
measure: Change From Baseline in Mayo score
timeFrame: Baseline, Week 8
measure: Change From Baseline in Partial Mayo Score
timeFrame: Baseline, Week 8
measure: Change From Baseline in Fecal Calprotectin
timeFrame: Baseline, Week 8
measure: Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts)
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: AJM300/CT3 trial site 41
state: Aichi
city: Nagoya
country: Japan
facility: AJM300/CT3 trial site 57
state: Aichi
city: Nagoya
country: Japan
facility: AJM300/CT3 trial site 63
state: Aichi
city: Toyoake
country: Japan
facility: AJM300/CT3 trial site 9
state: Aichi
city: Toyohashi
country: Japan
facility: AJM300/CT3 trial site 33
state: Aichi
city: Toyota
country: Japan
facility: AJM300/CT3 trial site 42
state: Aichi
city: Hirosaki
country: Japan
facility: AJM300/CT3 trial site 39
state: Aomori
city: Hirosaki
country: Japan
facility: AJM300/CT3 trial site 49
state: Aomori
city: Kashiwa
country: Japan
facility: AJM300/CT3 trial site 11
state: Chiba
city: Kashiwa
country: Japan
facility: AJM300/CT3 trial site 51
state: Chiba
city: Sakura
country: Japan
facility: AJM300/CT3 trial site 73
state: Chiba
city: Urayasu
country: Japan
facility: AJM300/CT3 trial site 54
state: Chiba
city: Matsuyama
country: Japan
facility: AJM300/CT3 trial site 81
state: Ehime
city: Kurume
country: Japan
facility: AJM300/CT3 trial site 53
state: Fukuoka
city: Tikushino
country: Japan
facility: AJM300/CT3 trial site 24
state: Fukuoka
city: Isesaki
country: Japan
facility: AJM300/CT3 trial site 55
state: Gunma
city: Fukuyama
country: Japan
facility: AJM300/CT3 trial site 35
state: Hiroshima
city: Asahikawa
country: Japan
facility: AJM300/CT3 trial site 18
state: Hokkaido
city: Asahikawa
country: Japan
facility: AJM300/CT3 trial site 26
state: Hokkaido
city: Sapporo
country: Japan
facility: AJM300/CT3 trial site 2
state: Hokkaido
city: Sapporo
country: Japan
facility: AJM300/CT3 trial site 3
state: Hokkaido
city: Sapporo
country: Japan
facility: AJM300/CT3 trial site 4
state: Hokkaido
city: Akashi
country: Japan
facility: AJM300/CT3 trial site 79
state: Hyogo
city: Kobe
country: Japan
facility: AJM300/CT3 trial site 34
state: Hyogo
city: Nishinomiya
country: Japan
facility: AJM300/CT3 trial site 64
state: Hyogo
city: Kasama
country: Japan
facility: AJM300/CT3 trial site 82
state: Ibaraki
city: Tsukuba
country: Japan
facility: AJM300/CT3 trial site 75
state: Ibaraki
city: Morioka
country: Japan
facility: AJM300/CT3 trial site 19
state: Iwate
city: Takamatsu
country: Japan
facility: AJM300/CT3 trial site 16
state: Kagawa
city: Kamakura
country: Japan
facility: AJM300/CT3 trial site 12
state: Kanagawa
city: Sagamihara
country: Japan
facility: AJM300/CT3 trial site 14
state: Kanagawa
city: Sagamihara
country: Japan
facility: AJM300/CT3 trial site 32
state: Kanagawa
city: Yokohama
country: Japan
facility: AJM300/CT3 trial site 13
state: Kanagawa
city: Yokohama
country: Japan
facility: AJM300/CT3 trial site 6
state: Kanagawa
city: Tsu
country: Japan
facility: AJM300/CT3 trial site 47
state: Mie
city: Yokkaichi
country: Japan
facility: AJM300/CT3 trial site 46
state: Mie
city: Sendai
country: Japan
facility: AJM300/CT3 trial site 45
state: Miyagi
city: Sendai
country: Japan
facility: AJM300/CT3 trial site 50
state: Miyagi
city: Sendai
country: Japan
facility: AJM300/CT3 trial site 78
state: Miyagi
city: Nagaoka
country: Japan
facility: AJM300/CT3 trial site 22
state: Nigata
city: Kurashiki
country: Japan
facility: AJM300/CT3 trial site 15
state: Okayama
city: Kurashiki
country: Japan
facility: AJM300/CT3 trial site 70
state: Okayama
city: Higashiosaka
country: Japan
facility: AJM300/CT3 trial site 77
state: Osaka
city: Osakasayama
country: Japan
facility: AJM300/CT3 trial site 76
state: Osaka
city: Takatsuki
country: Japan
facility: AJM300/CT3 trial site 10
state: Osaka
city: Ageo
country: Japan
facility: AJM300/CT3 trial site 40
state: Saitama
city: Ageo
country: Japan
facility: AJM300/CT3 trial site 5
state: Saitama
city: Tokorozawa
country: Japan
facility: AJM300/CT3 trial site 72
state: Saitama
city: Hamamatsu
country: Japan
facility: AJM300/CT3 trial site 17
state: Shizuoka
city: Ashikaga
country: Japan
facility: AJM300/CT3 trial site 60
state: Tochigi
city: Shimotsuga
country: Japan
facility: AJM300/CT3 trial site 29
state: Tochigi
city: Utsunomiya
country: Japan
facility: AJM300/CT3 trial site 71
state: Tochigi
city: Bunkyo
country: Japan
facility: AJM300/CT3 trial site 61
state: Tokyo
city: Bunkyo
country: Japan
facility: AJM300/CT3 trial site 68
state: Tokyo
city: Chiyoda
country: Japan
facility: AJM300/CT3 trial site 59
state: Tokyo
city: Chuo
country: Japan
facility: AJM300/CT3 trial site 30
state: Tokyo
city: Hachioji
country: Japan
facility: AJM300/CT3 trial site 31
state: Tokyo
city: Minato
country: Japan
facility: AJM300/CT3 trial site 56
state: Tokyo
city: Minato
country: Japan
facility: AJM300/CT3 trial site 66
state: Tokyo
city: Mitaka
country: Japan
facility: AJM300/CT3 trial site 80
state: Tokyo
city: Shinagawa
country: Japan
facility: AJM300/CT3 trial site 38
state: Tokyo
city: Shinjuku
country: Japan
facility: AJM300/CT3 trial site 21
state: Tokyo
city: Shinjuku
country: Japan
facility: AJM300/CT3 trial site 52
state: Tokyo
city: Shūnan
country: Japan
facility: AJM300/CT3 trial site 8
state: Yamaguchi
city: Kofu
country: Japan
facility: AJM300/CT3 trial site 23
state: Yamanashi
city: Chiba
country: Japan
facility: AJM300/CT3 trial site 44
city: Fukuoka
country: Japan
facility: AJM300/CT3 trial site 43
city: Fukuoka
country: Japan
facility: AJM300/CT3 trial site 58
city: Fukuoka
country: Japan
facility: AJM300/CT3 trial site 69
city: Gifu
country: Japan
facility: AJM300/CT3 trial site 67
city: Hiroshima
country: Japan
facility: AJM300/CT3 trial site 28
city: Hiroshima
country: Japan
facility: AJM300/CT3 trial site 36
city: Hiroshima
country: Japan
facility: AJM300/CT3 trial site 74
city: Kyoto
country: Japan
facility: AJM300/CT3 trial site 62
city: Kyoto
country: Japan
facility: AJM300/CT3 trial site 7
city: Nagasaki
country: Japan
facility: AJM300/CT3 trial site 48
city: Oita
country: Japan
facility: AJM300/CT3 trial site 37
city: Okayama
country: Japan
facility: AJM300/CT3 trial site 65
city: Osaka
country: Japan
facility: AJM300/CT3 trial site 1
city: Saga
country: Japan
facility: AJM300/CT3 trial site 20
city: Saga
country: Japan
facility: AJM300/CT3 trial site 25
city: Toyama
country: Japan
facility: AJM300/CT3 trial site 27
Study officials:
References:
citation: 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.