UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of filgotinib for refractory pouchitis in patients with ulcerative colitis
Acronym	Efficacy of filgotinib for pouchitis
Scientific Title	Efficacy and safety of Janus kinase 1 inhibitor for chronic pouchitis in patients with ulcerative colitis
Scientific Title:Acronym	Efficacy of Janus kinase 1 inhibitor for pouchitis
Region	Japan

Condition
Condition	ulcerative colitis, pouchitis
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of filgochinib for pouchitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	imprpvement by using modified pouchitis activity index with treatment.(Evaluations will be performed after 12weeks and 54 weeks of induction.
Key secondary outcomes	Incidence and kinds of adverse events during treatment. Secession from antibiotics use. Alteration of antibiotics dosage.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment with filgochinib
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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Anti-biotics dependent or refractory pouchitis.
Key exclusion criteria	Patients who dose not agree the treatment with filgochinib.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Ikeuchi
Organization	Hyogo medical university
Division name	Department of Gastroenterological surgery
Zip code	6638501
Address	1-1 Mukogawacho, Nshinomiya city, Hyogo pref
TEL	0798456371
Email	ikeuci2s@hyo-med.ac.jp

Public contact
Name of contact person	1st name Motoi Middle name Last name Uchino
Organization	Hyogo medical university
Division name	Department of Gastroenterological surgery
Zip code	6638501
Address	1-1 Mukogawacho, Nshinomiya city, Hyogo pref
TEL	0798456371
Homepage URL
Email	uchino2s@hyo-med.ac.jp

Sponsor
Institute	Hyogo medical university Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery, Hyogo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo medical university
Address	1-1 Mukogawacho, Nishinomiya, Hyogo
Tel	0798456371
Email	uchino2s@hyo-med.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	2022 Year 07 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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 01 Day
Date of IRB	2022 Year 06 Month 30 Day
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2025 Year 12 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	2022 Year 06 Month 16 Day
Last modified on	2022 Year 06 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054693