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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02620046
Date of registration: 19/11/2015
Prospective Registration: Yes
Primary sponsor: Takeda
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: April 15, 2016
Target sample size: 692
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02620046
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Argentina Australia Belgium Bosnia and Herzegovina Brazil Bulgaria Canada Colombia
Croatia Czech Republic Czechia Denmark Estonia Germany Hungary Israel
Italy Japan Korea, Republic of Lithuania Mexico Netherlands Poland Romania
Russian Federation Serbia Slovakia South Africa Spain Sweden Taiwan Turkey
Ukraine United Kingdom United States
Contacts
Name:     Medical Director Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
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 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Colitis, Ulcerative
Crohn Disease
Intervention(s)
Drug: Vedolizumab SC
Primary Outcome(s)
Percentage of Participants with Study Drug Related Treatment Emergent Adverse Events (AEs) and Serious AEs [Time Frame: From start of study medication through 18 weeks after the last dose]
Secondary Outcome(s)
Percentage of Participants with Adverse Events of Special Interest (AESIs) [Time Frame: From start of study medication through 18 weeks after the last dose]
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]
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]
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]
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]
Secondary ID(s)
16/LO/0110
163300410A0052
189751
2015-000482-31
JapicCTI-163220
MLN0002SC-3030
MLN0002SC-3030CTIL
MOH_2017-01-05_000040
NL55765.056.16
U1111-1168-0921
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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