A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 15 January 2024
• Main ID: NCT02620046
• Date of registration: 19/11/2015
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
• 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: 746
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02620046
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel 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
• 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

Crohn's Disease

Colitis, Ulcerative

Intervention(s)

Drug: Vedolizumab SC

Primary Outcome(s)

Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment [Time Frame: From start of study medication through 18 weeks after the last dose]

Secondary Outcome(s)

Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment [Time Frame: From start of study medication through 18 weeks after the last dose]

Percentage of Participants with Crohn's Disease (CD) Achieving Clinical Remission [Time Frame: From Week 0 (Day 1) up to 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 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]

Percentage of Participants with Crohn's Disease Achieving 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)

MLN0002SC-3030CTIL

16/LO/0110

163300410A0052

189751

MLN0002SC-3030

MOH_2017-01-05_000040

NL55765.056.16

U1111-1168-0921

2015-000482-31

JapicCTI-163220

Source(s) of Monetary Support

Please refer to primary and secondary sponsors