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Vedolizumab Subcutaneous Long-Term Open-Label Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02620046
Recruitment Status : Active, not recruiting
First Posted : December 2, 2015
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE November 19, 2015
First Posted Date  ICMJE December 2, 2015
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE April 15, 2016
Estimated Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vedolizumab Subcutaneous Long-Term Open-Label Extension Study
Official Title  ICMJE 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
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).
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colitis, Ulcerative
  • Crohn Disease
Intervention  ICMJE Drug: Vedolizumab SC
Vedolizumab SC 108 mg injection QW
Study Arms  ICMJE
  • 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 .
    Intervention: Drug: Vedolizumab SC
  • 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.
    Intervention: Drug: Vedolizumab SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2015)
692
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2022
Estimated Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Croatia,   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
Removed Location Countries Colombia,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02620046
Other Study ID Numbers  ICMJE MLN0002SC-3030
U1111-1168-0921 ( Registry Identifier: WHO )
2015-000482-31 ( EudraCT Number )
JapicCTI-163220 ( Registry Identifier: JapicCTI )
MLN0002SC-3030CTIL ( Registry Identifier: Israel )
16/LO/0110 ( Registry Identifier: NRES )
NL55765.056.16 ( Registry Identifier: CCMO )
189751 ( Registry Identifier: HC-CTD )
163300410A0052 ( Registry Identifier: NREC )
MOH_2017-01-05_000040 ( Other Identifier: CRS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Clinical Science Takeda
PRS Account Takeda
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP