World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 20 April 2020
Main ID:  JPRN-JapicCTI-163220
Date of registration: 08/04/2016
Prospective Registration: Yes
Primary sponsor: Takeda Pharmaceutical Company Limited
Public title: Vedolizumab Subcutaneous Long-Term Open-Label Extension Study
Scientific title: A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease
Date of first enrolment: 15/4/2016
Target sample size: 692
Recruitment status: complete
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-163220
Study type:  INTERVENTIONAL
Study design:  open-label extension (OLE) study  
Phase:  3
Countries of recruitment
Japan, Refer to "Other"section
Contacts
Name: Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information   
Address:  https://www.takeda.com/who-we-are/contact-us/
Telephone: +81-6-6204-2111
Email: -
Affiliation: 
Name: Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information   
Address:  https://www.takeda.com/who-we-are/contact-us/
Telephone: +81-6-6204-2111
Email: -
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.
Exclusion criteria: 1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.
2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety.
3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).


Age minimum: 18
Age maximum: 80
Gender: BOTH
Health Condition(s) or Problem(s) studied
Ulcerative colitis or Crohn's disease
Intervention(s)
Intervention name : Vedolizumab SC 108 mg
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Group A: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who completed the Maintenance Period (Week 52), or were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6 will receive vedolizumab SC 108 mg Q2W; Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to disease worsening or need for rescue medications will receive vedolizumab SC 108 mg QW.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Primary Outcome(s)
safety
Percentage of Participants with Study Drug Related Treatment Emergent Adverse Events (AEs) and Serious AEs
Timeframe: From start of study medication through 18 weeks after the last dose
Secondary Outcome(s)
safety
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: From start of study medication through 18 weeks after the last dose
AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).
efficacy
Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response
Time Frame: From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and >=25% from baseline, with an accompanying decrease in rectal bleeding subscore of >=1 point from baseline or absolute rectal bleeding subscore of =<1 point
efficacy
Percentage of Participants with Crohn's Disease Clinical Response
Time Frame: From Week 0 (Day 1) up to commercial availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Clinical response is defined as a decrease in HBI score of >=3 points from baseline.
efficacy
Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission
Time Frame: From Week 0 (Day 1) up to commercial availability of vedolizumab SC, withdrawal by participant, or study closure, up to 7 years
Clinical remission is defined as a partial Mayo score of =< 2 with no individual subscore >1.
efficacy
Percentage of Participants with Crohn's Disease Achieving Clinical Remission
Time Frame: From Week 0 (Day 1) up to commercial availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Clinical remission is defined as total HBI score of =<4 points.
Secondary ID(s)
2015-000482-31
NCT02620046
Source(s) of Monetary Support
-
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 17/02/2016
Contact:
-
Hayashi Tounyobyo Clinic IRB
-
-
Results
Results available:
Date Posted:
Date Completed: 10/02/2022
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history