APD334-303 - ELEVATE UC OLE

• Research type

  Research Study

• Full title

  An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

• IRAS ID

  266985

• Contact name

  Peter Irving

• Contact email

  Peter.Irving@gstt.nhs.uk

• Sponsor organisation

  Arena Pharmaceuticals Inc.

• Eudract number

  2018-003987-29

• Clinicaltrials.gov Identifier

  NCT03950232

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  5 years, 1 months, 22 days

• Research summary

  The primary objective of this open-label extension study is to assess the long-term safety and effectiveness of etrasimod in subjects with moderately to severely active ulcerative colitis. Each subject will be enrolled in the study for up to 260 weeks (5 years) of treatment and 2 weeks of follow-up.
  
  The study will be conducted in up to 702 participants worldwide who have participated in one of 2 studies (APD334-301 or APD334-302).

  Health Status, examined disease:
  Ulcerative Colitis

  Intervention:
  Active drug: etrasimod (oral tablet) taken once daily, for up to 260 weeks (up to 5 years).

  Key Inclusion and Exclusion criteria:
  Inclusion:
  • Must have met the eligibility criteria and have been enrolled in one of the two parent studies (APD334-301 or APD334-302) and completed the Week 52 visit or met Week 12 worsening criteria (APD334-301) or completed the Week 12 visit (APD334-302).
  Exclusion:
  • If the study doctor considers the subject to be unsuitable for any reason to participate in the OLE study
  • Certain health or laboratory test related exclusions.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  19/LO/1729

• Date of REC Opinion

  22 Jan 2020

• REC opinion

  Further Information Favourable Opinion