UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051508 |
|---|---|
| Receipt number | R000057505 |
| Scientific Title | Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication |
| Date of disclosure of the study information | 2023/07/03 |
| Last modified on | 2025/10/27 00:46:31 |
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Basic information
Public title
Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication
Acronym
ASPECT study
Scientific Title
Retrospective observational study of AJM300 CT3 trial investigating serum biomarkers, patient reported outcomes and maintenance medication
Scientific Title:Acronym
ASPECT study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The remaining blood samples (cryopreserved serum) collected in the AJM300 (nonproprietary name: carotegrast methyl) trial (CT3 Trial) will be used to assay biomarkers (LRG, anti-integrin alpha(v) beta(6) antibody titer) that had not been assayed in the trial, in order to assess efficacy-related biomarkers.
Patient symptom diaries (occurrence of bloody stool, bowel movement frequency) will be collected to study the time points at which AJM300 had an effect on the occurrence of bloody stool and bowel movement frequency.
Maintenance medication (medication, dose, duration of dosing) will be studied in patients who achieved remission as a result of AJM300 treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the Mayo endoscopic score (MES) and biomarkers (LRG, anti-integrin alpha(v) beta(6) antibody titer) at the end of treatment
Key secondary outcomes
1) MES-biomarker correlation at each time point
2) Comparison of change over time in biomarkers between patients who did and did not achieve remission
3) Use of Biomarkers for Predicting Response and Exploring End-of-Treatment Criteria
4) Comparison of change in course of recovery from bloody stool and normalization of bowel movement frequency between placebo group and active drug group
5) Assessment of bloody stool/bowel movement status after 1, 2, 3, 4, 5, and 6 weeks of treatment, and effect on mucosal score at Week 8
6) Correlation between laboratory values (e.g., FCP, CRP) and biomarkers
7) Correlation between biomarkers and duration of remission
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who were enrolled in the CT3 Trial
2. Patients at sites that agreed to participate in the trial
Key exclusion criteria
1. Patients who have declined to participate in the trial
Target sample size
203
Research contact person
Name of lead principal investigator
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Matsuoka |
Organization
Toho University Sakura Medical Center
Division name
Gastroenterology Chair of Internal Medicine
Zip code
285-8741
Address
564-1 Shimoshizu, Sakura-shi, Chiba
TEL
043-462-8811
katsuyoshi.matsuoka@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Saiko |
| Middle name | |
| Last name | Tamura |
Organization
Satt Co.,Ltd
Division name
Clinical Research Promotion Group
Zip code
160-0022
Address
5F ACN Shinjuku Building, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5312-5026
Homepage URL
ct3ret@sa-tt.co.jp
Sponsor or person
Institute
Toho University Sakura Medical Center
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd
KISSEI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
EA Pharma Co.,Ltd
KISSEI PHARMACEUTICAL CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toho University Sakura Medical Center
Address
564-1 Shimoshizu, Sakura-shi, Chiba
Tel
043-462-8811(2616)
sakura.rinri@ext.toho-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
1 札幌厚生病院（北海道）
2 旭川医科大学病院（北海道）
3 旭川厚生病院（北海道）
4 大森敏秀胃腸科クリニック（埼玉県）
5 東邦大学医療センター佐倉病院（千葉県）
6 辻仲病院柏の葉（千葉県）
7 千葉大学医学部附属病院（千葉県）
8 関内鈴木クリニック（神奈川県）
9 医療法人恵仁会 松島病院（神奈川県）
10 大阪公立大学医学部附属病院（大阪府）
11 チクバ外科・胃腸科・肛門科病院（岡山県）
12 県立広島病院（広島県）
13 徳山中央病院（山口県）
14 佐賀大学医学部附属病院（佐賀県）
15 藤田胃腸科病院（大阪府）
16 順天堂大学医学部附属順天堂医院（東京都）
17 松田病院（静岡県）
18 東北大学病院（宮城県）
19 獨協医科大学病院（栃木県）
20 東京山手メディカルセンター（東京都）
21 聖路加国際病院（東京都）
22 東海大学医学部付属八王子病院（東京都）
23 北里大学病院（神奈川県）
24 長岡中央綜合病院（新潟県）
25 山梨県立中央病院（山梨県）
26 豊橋市民病院（愛知県）
27 小畑内科クリニック（京都府）
28 神戸市立医療センター中央市民病院（兵庫県）
29 広島大学病院（広島県）
30 福山医療センター（広島県）
31 広島市立広島市民病院（広島県）
32 福岡大学筑紫病院（福岡県）
33 佐賀県医療センター好生館（佐賀県）
34 長崎大学病院（長崎県）
35 石田消化器ＩＢＤクリニック（大分県）
36 弘前大学医学部附属病院（青森県）
37 弘前総合医療センター（青森県）
38 仙台医療センター（宮城県）
39 東京慈恵会医科大学附属柏病院（千葉県）
40 慶應義塾大学病院（東京都）
41 名古屋大学医学部附属病院（愛知県）
42 よこやまIBDクリニック（愛知県）
43 兵庫医科大学病院（兵庫県）
44 順天堂大学医学部附属浦安病院（千葉県）
45 岡山大学病院（岡山県）
46 豊田厚生病院（愛知県）
47 伊勢崎市民病院（群馬県）
48 防衛医科大学校病院（埼玉県）
49 北里大学北里研究所病院（東京都）
50 相模原協同病院（神奈川県）
51 岐阜大学医学部附属病院（岐阜県）
52 だいどうクリニック（愛知県）
53 福岡大学病院（福岡県）
54 福岡県済生会福岡総合病院（福岡県）
55 三井記念病院（東京都）
56 東京医科歯科大学医学部附属病院（東京都）
57 倉敷中央病院（岡山県）
58 足利赤十字病院（栃木県）
59かんけ胃腸クリニック（栃木県）
60近畿大学病院（大阪府）
61若草第一病院（大阪府）
62杏林大学医学部付属病院（東京都）
63イムス明理会仙台総合病院（宮城県）
64明石医療センター（兵庫県）
65札幌東徳洲会病院（北海道）
66札幌徳洲会病院（北海道）
67大船中央病院（神奈川県）
68三重県大学医学部附属病院（三重県）
69NTT東日本関東病院（東京都）
70久留米大学病院（福岡県）
71茨城県立中央病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00535-025-02299-9
Number of participants that the trial has enrolled
186
Results
In moderate ulcerative colitis (partial Mayo <=5), carotegrast methyl increased remission (56.1 % vs.33.3% ).Baseline anti-integrin alpha-v-beta-6 antibodies < 44.6 U/mL predicted better remission (49.1% vs.26.8 %). Symptoms improved from week 2.Fecal calprotectin 387.5 micrograms per gram predicted endoscopic remission with 92%sensitivity. Most patients maintained remission with oral 5-aminosalicylic acid, achieving one-year rate of 56.5 %.
Results date posted
| 2025 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 09 | Month | 22 | Day |
Baseline Characteristics
In this study, a total of 186 patients with ulcerative colitis (UC) were analyzed. The mean age was approximately 43 years, with a nearly equal gender distribution (about 63-64% male). Baseline disease activity, measured by the Mayo score, had a median of 8.0, indicating moderate activity, with no significant differences between the carotegrast methyl (CGM) and placebo groups. Patients who achieved clinical remission at the end of treatment tended to have lower median Mayo scores, partial Mayo scores, stool frequency subscores, and rectal bleeding subscores at baseline.
Participant flow
This study is a retrospective observational study involving a total of 203 patients with ulcerative colitis (UC) enrolled in the CT3 trial conducted in 2023. Data were available for 186 patients, comprising 96 in the colestipol methyl ester (CGM) group and 90 in the placebo group. The specific process is as follows: Informed consent was obtained from all patients prior to study initiation.
Clinical remission status at treatment completion was assessed based on daily symptom diaries completed by patients. For patients achieving remission, medication usage during maintenance therapy was tracked for one year thereafter. Biomarkers (LRG, CRP, FCP,anti-integrin alpha-v beta-6 antibody titres) were measured from serum samples. Analyses also examined correlations and predictive capabilities between endoscopic evaluation (MES) and biomarkers.
Adverse events
None
Outcome measures
Comparison of baseline patient characteristics between remission and non-remission groups
(Baseline characteristics in patients with and without clinical remission at end of treatment)
Efficacy prediction based on biomarkers
(Predictive value of biomarkers such as leucine-rich alpha-2 glycoprotein (LRG), C-reactive protein (CRP), fecal calprotectin (FCP), and anti-integrin alpha-v beta-6 antibody titres)
Temporal changes in symptom resolution
(Changes over time in stool frequency and rectal bleeding resolution)
Clust
er analysis of rectal bleeding resolution
(Classification of patients based on rectal bleeding improvement patterns)
Correlation between biomarkers and endoscopic severity (MES)
(Relationship between biomarker levels and Mayo endoscopic subscore at end of treatment)
Cut-off value determination for biomarkers predicting endoscopic healing
(Sensitivity, specificity, and ROC analysis for biomarkers predicting MES 0/1)
Clinical remission maintenance rate
(Proportion of patients maintaining remission over 1 year after treatment)
Analysis of maintenance therapy regimens post-remission
(Types and doses of drugs used for remission maintenance)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 05 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 04 | Day |
Other
Other related information
-
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057505
