Colitis, UlcerativePhase 3NCT03531892
A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
A Phase 3 study testing AJM300 in people with Colitis, Ulcerative, run by EA Pharma Co., Ltd. at 82 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 74 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- AJM300
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 82 sitesJapan
- Study dates
- 6 Jun 2018to 28 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Major Inclusion Criteria:
- 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
Major Exclusion Criteria:
- 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.
- Participants who are participants of another clinical study including follow-up observation at the time of informed consent.
- Participants who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol.
- Participants who received investigational drugs in the study of AJM300.
- Participants determined to be ineligible for participation in this study by the investigator or sub-investigator.
Trial locations and contacts
82 sites in 1 country.
82 sites in 1 country
Japan82 sites
AJM300/CT3 trial site 40
Ageo, Saitama
AJM300/CT3 trial site 5
Ageo, Saitama
AJM300/CT3 trial site 79
Akashi, Hyōgo
AJM300/CT3 trial site 18
Asahikawa, Hokkaido
AJM300/CT3 trial site 26
Asahikawa, Hokkaido
AJM300/CT3 trial site 60
Ashikaga, Tochigi
AJM300/CT3 trial site 61
Bunkyo, Tokyo
AJM300/CT3 trial site 68
Bunkyo, Tokyo
AJM300/CT3 trial site 44
Chiba
AJM300/CT3 trial site 59
Chiyoda City, Tokyo
AJM300/CT3 trial site 30
Chūō, Tokyo
AJM300/CT3 trial site 43
Fukuoka
AJM300/CT3 trial site 58
Fukuoka
AJM300/CT3 trial site 69
Fukuoka
AJM300/CT3 trial site 35
Fukuyama, Hiroshima
AJM300/CT3 trial site 67
Gifu
AJM300/CT3 trial site 31
Hachiōji, Tokyo
AJM300/CT3 trial site 17
Hamamatsu, Shizuoka
AJM300/CT3 trial site 77
Higashiosaka, Osaka
AJM300/CT3 trial site 39
Hirosaki, Aomori
AJM300/CT3 trial site 49
Hirosaki, Aomori
AJM300/CT3 trial site 28
Hiroshima
AJM300/CT3 trial site 36
Hiroshima
AJM300/CT3 trial site 74
Hiroshima
AJM300/CT3 trial site 55
Isesaki, Gunma
AJM300/CT3 trial site 12
Kamakura, Kanagawa
AJM300/CT3 trial site 82
Kasama, Ibaraki
AJM300/CT3 trial site 11
Kashiwa, Chiba
AJM300/CT3 trial site 51
Kashiwa, Chiba
AJM300/CT3 trial site 34
Kobe, Hyōgo
AJM300/CT3 trial site 23
Kofu, Yamanashi
AJM300/CT3 trial site 15
Kurashiki, Okayama-ken
AJM300/CT3 trial site 70
Kurashiki, Okayama-ken
AJM300/CT3 trial site 53
Kurume, Fukuoka
AJM300/CT3 trial site 62
Kyoto
AJM300/CT3 trial site 7
Kyoto
AJM300/CT3 trial site 81
Matsuyama, Ehime
AJM300/CT3 trial site 56
Minato, Tokyo
AJM300/CT3 trial site 66
Minato, Tokyo
AJM300/CT3 trial site 80
Mitaka, Tokyo
AJM300/CT3 trial site 19
Morioka, Iwate
AJM300/CT3 trial site 22
Nagaoka, Niigata
AJM300/CT3 trial site 48
Nagasaki
AJM300/CT3 trial site 41
Nagoya, Aichi-ken
AJM300/CT3 trial site 57
Nagoya, Aichi-ken
AJM300/CT3 trial site 63
Nagoya, Aichi-ken
AJM300/CT3 trial site 64
Nishinomiya, Hyōgo
AJM300/CT3 trial site 37
Ōita
AJM300/CT3 trial site 65
Okayama
AJM300/CT3 trial site 1
Osaka
AJM300/CT3 trial site 20
Saga
AJM300/CT3 trial site 25
Saga
AJM300/CT3 trial site 14
Sagamihara, Kanagawa
AJM300/CT3 trial site 32
Sagamihara, Kanagawa
AJM300/CT3 trial site 73
Sakura, Chiba
AJM300/CT3 trial site 2
Sapporo, Hokkaido
AJM300/CT3 trial site 3
Sapporo, Hokkaido
AJM300/CT3 trial site 4
Sapporo, Hokkaido
AJM300/CT3 trial site 76
Sayama, Osaka
AJM300/CT3 trial site 45
Sendai, Miyagi
AJM300/CT3 trial site 50
Sendai, Miyagi
AJM300/CT3 trial site 78
Sendai, Miyagi
AJM300/CT3 trial site 29
Shimotsuga, Tochigi
AJM300/CT3 trial site 38
Shinagawa, Tokyo
AJM300/CT3 trial site 21
Shinjuku, Tokyo
AJM300/CT3 trial site 52
Shinjuku, Tokyo
AJM300/CT3 trial site 8
Shūnan, Yamaguchi
AJM300/CT3 trial site 16
Takamatsu, Kagawa-ken
AJM300/CT3 trial site 10
Takatsuki, Osaka
AJM300/CT3 trial site 24
Tikushino, Fukuoka
AJM300/CT3 trial site 72
Tokorozawa, Saitama
AJM300/CT3 trial site 27
Toyama
AJM300/CT3 trial site 9
Toyoake, Aichi-ken
AJM300/CT3 trial site 33
Toyohashi, Aichi-ken
AJM300/CT3 trial site 42
Toyota, Aichi-ken
AJM300/CT3 trial site 47
Tsu, Mie-ken
AJM300/CT3 trial site 75
Tsukuba, Ibaraki
AJM300/CT3 trial site 54
Urayasu, Chiba
AJM300/CT3 trial site 71
Utsunomiya, Tochigi
AJM300/CT3 trial site 46
Yokkaichi, Mie-ken
AJM300/CT3 trial site 13
Yokohama, Kanagawa
AJM300/CT3 trial site 6
Yokohama, Kanagawa
About this study
Official title: Phase III Study of AJM300 in Patients With Active Ulcerative Colitis
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
- Being tested
- AJM300, Placebo
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease, Ulcerative Colitis Type, Colitis, AJM300
- Medical subject headings
- Colitis, Ulcerative, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJM300Drug
Also called Carotegrast methyl
AJM300 film-coated tablets.
PlaceboDrug
Placebo matched to AJM300 tablets.
| Study group | Role | What they receive |
|---|---|---|
| AJM300 960mg/dose | Experimental | Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks. Receives: Drug: AJM300 |
| Placebo | Placebo comparator | Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 8
Secondary outcomes (12)
Clinical Remission Rate Based on Mayo Score
Clinical remission rate is defined by the percentage of participants with Mayo score <=2 and no subscore greater than (>) 1.
Measured: At Week 8
Mucosal Healing Rate
Mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore <=1.
Measured: At Week 8
Complete Mucosal Healing Rate
Complete mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore =0.
Measured: At Week 8
Clinical Response Rate Based on Partial 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 partial Mayo score and the change or the actual value of individual subscales. Partial Mayo score is used in clinical trials to assess UC disease activity. It consists of 3 subscales: stool frequency, rectal bleeding 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 partial Mayo score ranges from 0 to 9, with higher scores indicating more severe disease.
Measured: At Week 8
Clinical Remission Rate Based on Partial Mayo Score
Clinical remission rate is defined by the percentage of participants with partial Mayo score <=2 and no subscore >1.
Measured: At Week 8
Modified Clinical Remission Rate 1
Modified Clinical remission rate 1 is defined by percentage of participants who satisfies the three conditions such as: rectal bleeding subscore =0, Stool frequency subscore =0 and Endoscopic subscore <=1.
Measured: At Week 8
Modified Clinical Remission Rate 2
Modified Clinical remission rate 2 is defined by the percentage of participants who satisfies the three conditions such as: rectal bleeding subscore =0, a decrease in the stool frequency subscore of at least 1 point or an absolute stool frequency subscore of 0 or 1 and Endoscopic subscore <=1.
Measured: At Week 8
Percentage of Rectal Bleeding Subscore of 0
Percentage of rectal bleeding subscore of 0 means the percentage of participants with rectal bleeding score =0.
Measured: At Week 8
Change From Baseline in Mayo score
Mayo score is used in clinical trials to assess 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.
Measured: Baseline, Week 8
Change From Baseline in Partial Mayo Score
Partial Mayo score is used in clinical trials to assess UC disease activity. It consists of 3 subscales: stool frequency, rectal bleeding 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 9, with higher scores indicating more severe disease.
Measured: Baseline, Week 8
Change From Baseline in Fecal Calprotectin
Measured: Baseline, Week 8
Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts)
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start6 Jun 2018
- Primary completion9 Nov 2020
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- EA Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kissei Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531892
- Sponsor's protocol ID
- AJM300/CT3
- Other IDs
- JapicCTI-183924
- Status last verified
- Apr 2023
- First submitted
- 9 May 2018
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35366419
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of AJM300 in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03531892
- Acronym / sponsor ID
- AJM300/CT3
- Conditions
- Colitis, Ulcerative
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease, Ulcerative Colitis Type, Colitis, AJM300
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kissei Pharmaceutical Co., Ltd.
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AJM300 960mg/dose | Experimental | Drug: AJM300Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks. |
Who may qualify
- Ages
- 16 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AJM300Also: Carotegrast methylAJM300 film-coated tablets. | Drug | AJM300 960mg/dose |
| PlaceboPlacebo matched to AJM300 tablets. | Drug | Placebo |
Primary outcome
Clinical Response Rate Based on Mayo Score
Time frame: At Week 8
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.
12 secondary outcomes
Clinical Remission Rate Based on Mayo Score
Time frame: At Week 8
Mucosal Healing Rate
Time frame: At Week 8
Complete Mucosal Healing Rate
Time frame: At Week 8
Clinical Response Rate Based on Partial Mayo Score
Time frame: At Week 8
Clinical Remission Rate Based on Partial Mayo Score
Time frame: At Week 8
Modified Clinical Remission Rate 1
Time frame: At Week 8
Modified Clinical Remission Rate 2
Time frame: At Week 8
Percentage of Rectal Bleeding Subscore of 0
Time frame: At Week 8
Change From Baseline in Mayo score
Time frame: Baseline, Week 8
Change From Baseline in Partial Mayo Score
Time frame: Baseline, Week 8
Change From Baseline in Fecal Calprotectin
Time frame: Baseline, Week 8
Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts)
Time frame: Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 35366419Matsuoka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
82 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AJM300 in people with Colitis, Ulcerative, run by EA Pharma Co., Ltd. at 82 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response Rate Based on Mayo Score (time frame: At Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03531892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.