UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062354 |
|---|---|
| Receipt number | R000071357 |
| Scientific Title | Evaluation of Extended Ustekinumab (an IL-12/23p40 Inhibitor) Dosing Intervals for Maintenance of Remission in Patients with Refractory Ulcerative Colitis |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/27 17:31:39 |
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Basic information
Public title
Evaluation of Extended Ustekinumab Dosing Intervals for Remission Maintenance in Refractory Ulcerative Colitis
Acronym
Evaluation of Extended Ustekinumab Dosing Intervals for Maintenance of Remission in Patients with Ulcerative Colitis
Scientific Title
Evaluation of Extended Ustekinumab (an IL-12/23p40 Inhibitor) Dosing Intervals for Maintenance of Remission in Patients with Refractory Ulcerative Colitis
Scientific Title:Acronym
Evaluation of Extended Ustekinumab (an IL-12/23p40 Inhibitor) Dosing Intervals for Maintenance of Remission in Patients with Ulcerative Colitis
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ustekinumab (UST) is a monoclonal antibody targeting the p40 subunit shared by interleukin (IL)-12 and IL-23. Following induction therapy, patients transition to maintenance therapy with subcutaneous UST administered every 8 or 12 weeks, beginning 8 weeks after the initial intravenous infusion. Because the clinical remission rate at week 8 was less than 20% in the phase III trial, most patients in routine clinical practice initially receive maintenance therapy every 8 weeks, with extension to every 12 weeks considered after stable disease control has been achieved. However, evidence regarding the efficacy and safety of extending the UST dosing interval, as well as predictors of successful interval extension, remains limited in patients with ulcerative colitis.
The aim of this prospective study is to evaluate the efficacy and safety of extending the UST maintenance dosing interval from every 8 weeks to every 12 weeks in patients with ulcerative colitis. In addition, the study will investigate the success rate of dosing interval extension and identify predictors associated with successful interval extension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative remission maintenance rate in the 12-week interval extension group compared with the 8-week interval group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The maintenance dosing interval of UST 90 mg per dose subcutaneous injection will be extended from every 8 weeks to every 12 weeks.
Interventions/Control_2
UST 90 mg per dose subcutaneous injection will be continued every 8 weeks as maintenance therapy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis UC receiving maintenance therapy with subcutaneous UST 90 mg every 8 weeks will be included. Eligible patients must achieve clinical remission and mucosal healing one year after initiation of UST therapy. Mucosal healing is defined as endoscopic Mayo score 0 or 1 and fecal calprotectin level <=240 ug/g.
Key exclusion criteria
Patients younger than 20 years of age will be excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | ryoji |
| Middle name | |
| Last name | koshiba |
Organization
Osaka Medical and Pharmaceutical University
Division name
Second Department of Internal Medicine
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
0726831221
ryouji.koshiba@ompu.ac.jp
Public contact
Name of contact person
| 1st name | ryoji |
| Middle name | |
| Last name | koshiba |
Organization
Osaka Medical and Pharmaceutical University
Division name
Second Department of Internal Medicine
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
0726831221
Homepage URL
ryouji.koshiba@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of the Hospital Ethics Committee, Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi, Takatsuki, Osaka
Tel
0726831221
ompuh-kanri@ompu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 27 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071357
