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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02620046




Registration number
NCT02620046
Ethics application status
Date submitted
19/11/2015
Date registered
2/12/2015
Date last updated
13/03/2020

Titles & IDs
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
Secondary ID [1] 0 0
U1111-1168-0921
Secondary ID [2] 0 0
MLN0002SC-3030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab SC

Experimental: Group A: Vedolizumab SC 108 mg Q2W - 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 .

Experimental: Group B: Vedolizumab SC 108 mg QW - Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure.
Participants from current study who experience treatment failure while on study.


Treatment: Drugs: Vedolizumab SC
Vedolizumab SC 108 mg injection QW

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Study Drug Related Treatment Emergent Adverse Events (AEs) and Serious AEs
Timepoint [1] 0 0
From start of study medication through 18 weeks after the last dose
Secondary outcome [1] 0 0
Percentage of Participants with Adverse Events of Special Interest (AESIs) - AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).
Timepoint [1] 0 0
From start of study medication through 18 weeks after the last dose
Secondary outcome [2] 0 0
Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response - 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
Timepoint [2] 0 0
From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Secondary outcome [3] 0 0
Percentage of Participants with Crohn's Disease Clinical Response - Clinical response is defined as a decrease in HBI score of =3 points from baseline.
Timepoint [3] 0 0
From Week 0 (Day 1) up to commercial availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Secondary outcome [4] 0 0
Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission - Clinical remission is defined as a partial Mayo score of = 2 with no individual subscore >1.
Timepoint [4] 0 0
From Week 0 (Day 1) up to commercial availability of vedolizumab SC, withdrawal by participant, or study closure, up to 7 years
Secondary outcome [5] 0 0
Percentage of Participants with Crohn's Disease Achieving Clinical Remission - Clinical remission is defined as total HBI score of =4 points.
Timepoint [5] 0 0
From Week 0 (Day 1) up to commercial availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
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Final
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NSW,QLD,SA,VIC,WA
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Concord Repatriation General Hospital - Concord
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Nepean Hospital - Kingswood
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Mater Hospital Brisbane - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Tennyson Centre Day Hospital - Kurralta Park
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Ballarat Base Hospital - Ballarat
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Monash Medical Centre Clayton - Bentleigh East
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St Vincent's Hospital Melbourne - Fitzroy
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St Frances Xavier Cabrini Hospital - Malvern
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Royal Melbourne Hospital - Melbourne
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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St John of God Subiaco Hospital - Subiaco
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2139 - Concord
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2747 - Kingswood
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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5037 - Kurralta Park
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3350 - Ballarat
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3165 - Bentleigh East
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3065 - Fitzroy
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3144 - Malvern
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3000 - Melbourne
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3181 - Melbourne
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6150 - Murdoch
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6008 - Subiaco
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Uzhgorod
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Vinnytsia
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Zaporizhzhia
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Devon
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Greater London
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Norfolk
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Shropshire
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United Kingdom
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West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to obtain long term safety and tolerability data of vedolizumab
subcutaneous (vedolizumab SC) in participants with ulcerative colitis (UC) and Crohn's
disease (CD).
Trial website
https://clinicaltrials.gov/show/NCT02620046
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director Clinical Science
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
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