MLN0002SC-3030 Vedolizumab SC Long-Term, Open-Label, Extension Study

• Research type

  Research Study

• Full 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

• IRAS ID

  196203

• Contact name

  Charles Murray

• Contact email

  charlesmurray1@nhs.net

• Sponsor organisation

  Takeda Development Centre Europe, Ltd

• Eudract number

  2015-000482-31

• Duration of Study in the UK

  5 years, 1 months, 1 days

• Research summary

  This is an open-label extension (OLE) study to gather long-term safety and efficacy data for subcutaneous vedolizumab (vedolizumab SC) in participants with ulcerative colitis (UC) or Crohn’s disease (CD), to complement safety data gathered from Study MLN0002SC-3027 in UC participants and Study MLN0002SC-3031 in CD participants.

  The study will allow eligible participants from the MLN0002SC-3027 or MLN0002SC-3031 studies (the prior studies) to continue receiving vedolizumab SC for up to a maximum of 5 years (may vary from patient to patient based on clinical benefit), until the participant decides to withdraw from the study, or the Sponsor decides to close the study.

  All enrolled participants will receive the same dose of vedolizumab SC - 108 mg.
  Participants who either completed the Maintenance Period within the prior study (Week 52 assessment) or who did not achieve a clinical response at Week 6 but did achieve a clinical response at Week 14 will receive vedolizumab SC 108 mg once every 2 weeks (Q2W)
  Participants who withdrew early from the Maintenance Period within the prior study (due to disease worsening or need for rescue medications) will receive vedolizumab
  SC 108 mg once per week (QW).

  SC injections will be self-administered by the participant (or a caregiver, if preferred) at the clinic at Weeks 0, 4 and 8 and then every 8 weeks until the participant stops taking part in the study. All other SC injections will be performed by the participant (or their caregiver) at home in accordance with their weekly or every-other-week dosing regimen until they stop taking part in the study.

  It is anticipated that the duration of vedolizumab SC treatment will vary by patient based on continued benefit but will be up to a maximum of 5 years.

  Lay Summary of Results:
  lay summary results will be posted to Takeda's website (https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.takeda.com%2F&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7C77fad68fad5f4ef053dc08dd67d6e4bf%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638780894833031575%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=2eNW7Xgeoo4bP0Jqw%2FutJIWsBgP1rhUuMnVeLSnhmbQ%3D&reserved=0) after the results get released to clinicaltrials.gov and EudraCT at the end of March2025

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  16/LO/0110

• Date of REC Opinion

  21 Mar 2016

• REC opinion

  Further Information Favourable Opinion