UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058388 |
|---|---|
| Receipt number | R000066591 |
| Scientific Title | Effectiveness of guselkumab on ulcerative colitis patients with a history of ustekinumab loss of response |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/07 16:49:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of guselkumab on ulcerative colitis patients with a history of ustekinumab loss of response
Acronym
Effectiveness of guselkumab on ulcerative colitis patients with a history of ustekinumab loss of response
Scientific Title
Effectiveness of guselkumab on ulcerative colitis patients with a history of ustekinumab loss of response
Scientific Title:Acronym
Effectiveness of guselkumab on ulcerative colitis patients with a history of ustekinumab loss of response
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate the efficacy of GUS in UC patients with a history of UST loss of response (LoR).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Primary Endpoint>
The primary endpoint is to assess the change from baseline in the partial Mayo (pMayo) score in the induction period at 12 weeks after GUS administration.
<Secondary Endpoints>
The secondary endpoint is to assess the change from baseline in pMayo score in the maintenance period at 48 weeks after GUS administration.
The other endpoints include the clinical response, clinical remission, endoscopic response and endoscopic remission (if available) at 12 and 48 weeks after GUS administration, continuation rate of GUS as well as safety information.
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subjects with age 15 years or older at baseline.
2.Subjects must sign informed consent, and the consent of their legally acceptable representative must be obtained for subjects under 18 years of age.
3.Subjects with confirmed diagnosis of moderate to severe UC.
4.Subjects with a history of UST primary failure or LoR. Primary failure is defined as a patient who was unable to achieve clinical remission (pMayo 2 or less) despite the use of UST. LoR is defined as the recurrence/worsening of symptoms in a patient who had previously benefited from UST (worsening of pMayo score (pMayo 3 or more)).
5.Subjects with primary UST failure or LoR despite Q8w dosing regimen when prospectively enrolled.
6.Subjects who have initiated treatment with GUS at least 1 dose (for retrospective study).
7.Subjects with no tuberculosis infection.
Key exclusion criteria
1.Subjects who have a history of bowel surgery
2.Subjects with acute severe UC
3.Subjects with current pregnancy
4.Subjects with current malignancy, or active treatment for previously diagnosed malignancy.
5.Subjects with serious comorbidity including immunodeficiency, myocardial infarction, stroke, renal or hepatic failure, infection such as tuberculosis, abscess, opportunistic infection, or sepsis.
6.Subjects with already achieved symptomatic remission at baseline (stool frequency score: SFS = 0 or 1 and rectal bleeding score: RBS = 0.
7.Subjects currently enrolled or plan to be enrolled (during this study period) in any another Janssen sponsored study or non-Janssen-sponsored interventional study.
8.Patients with No baseline pMayo score.
9.Subjects who have been previously prescribed with p19 inhibitors (participated in GUS clinical trials, prescribed with mirikizumab or risankizumab).
10.Subjects who have used ADTs beyond 3 MOAs (mode of action) in the past.
11.Patients who have used UST and did not LoR but terminated with other reasons such as AE.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Inoue |
Organization
Janssen PharmaceuticalK.K.
Division name
Medical Affairs
Zip code
101-0065
Address
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
TEL
070-4214-1138
tinoue9@its.jnj.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Inoue |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs
Zip code
101-0065
Address
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
TEL
070-4214-1138
Homepage URL
tinoue9@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-profit organization MINS Research Ethics Committee
Address
St Shibuya Building, 1-15-14 Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2025 | Year | 07 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066591
