Vedolizumab Subcutaneous Long-Term Open-Label Extension Study
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|ClinicalTrials.gov Identifier: NCT02620046|
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : October 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative Crohn Disease||Drug: Vedolizumab SC||Phase 3|
The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating participants with UC or CD. This study will look at the long-term side effects and response/remission of UC and CD in participants who received vedolizumab SC in a prior vedolizumab SC study.
The study will enroll up to 692 patients. All participants enrolled in this study will have previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a clinical response at Week 6 but who did achieve a clinical response at Week 14 after having received a third vedolizumab IV infusion at Week 6 in their previous study, will receive open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early from the Maintenance Period of their previous study due to disease worsening or need for rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW). Participants who experience treatment failure (disease worsening or need for rescue medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.
This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC study will continue until vedolizumab SC becomes commercially available, the participant withdraws from the study, or the sponsor decides to close the study. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||692 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||April 15, 2016|
|Estimated Primary Completion Date :||August 11, 2021|
|Estimated Study Completion Date :||February 10, 2022|
Experimental: Group A: Vedolizumab SC 108 mg Q2W
Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who:
Drug: Vedolizumab SC
Vedolizumab SC 108 mg injection QW
Experimental: Group B: Vedolizumab SC 108 mg QW
Drug: Vedolizumab SC
Vedolizumab SC 108 mg injection QW
- 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 ]
- 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).
- 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
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620046
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
Show 315 Study Locations
|Study Director:||Medical Director Clinical Science||Takeda|