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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
Sponsor:
Information provided by (Responsible Party):
Takeda

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).

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Crohn Disease Drug: Vedolizumab SC Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 692 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arm Intervention/treatment
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 .
Drug: Vedolizumab SC
Vedolizumab SC 108 mg injection QW

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.
Drug: Vedolizumab SC
Vedolizumab SC 108 mg injection QW




Primary Outcome Measures :
  1. 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 Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

  Show 315 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02620046     History of Changes
Other Study ID Numbers: 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 )
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Vedolizumab
Gastrointestinal Agents