VERDICT

• Research type

  Research Study

• Full title

  VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target

• IRAS ID

  278464

• Contact name

  Gordon Moran

• Contact email

  gordon.moran@nottingham.ac.uk

• Sponsor organisation

  Alimentiv Inc.

• Eudract number

  2019-002485-12

• Clinicaltrials.gov Identifier

  NCT04259138

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  3 years, 10 months, 0 days

• Research summary

  Researchers are investigating what is the optimal treatment targets in patients with Ulcerative Colitis (UC), in order to keep the disease in remission and prevent complications.

  This study will enroll approximately 660 participants at approximately 60 sites in 11 countries, for approximately two years. Participants will be asked to go to the study clinic for 9 visits. Additional visits may be required as needed.

  Participants with active UC will be randomized to 1 of 3 groups, each with a different treatment targets defined as:

  Group 1: corticosteroid-free symptomatic remission
  Group 2: corticosteroid-free endoscopic + symptomatic remission
  Group 3: corticosteroid-free histologic + endoscopic + symptomatic remission

  Participants will be assigned to 1 of the 3 treatment algorithms according to their existing medical therapy for UC at the time of screening.

  Algorithm A: Participants not on any treatment. They will start the study with oral 5-ASA or immunosuppressive therapy.
  Algorithm B: Participants taking nonbiologic UC therapies. They will start the study on vedolizumab.
  Algorithm C: Participants taking anti-TNF, tofacitinib or ustekinumab therapy. They will be switched to vedolizumab at the beginning of the study.

  Vedolizumab will be provided through intravenous (IV) infusion (by injection), with the option to switch to subcutaneous therapy every 2 weeks after participants have reached respective targets on IV.

  If participants have reached their remission target, they will continue treatment at current dose, if not, treatment will be escalated as per the treatment algorithm and another assessment will take place 16 weeks later.

  Participants who are prescribed vedolizumab and have achieved their target remission by week 48, may continue to receive vedolizumab up until week 96, but participants who have not achieved their target remission by week 48, will no longer be provided vedolizumab through this study.

  The study is funded by a Takeda Development Center Americas Inc.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  20/SC/0164

• Date of REC Opinion

  14 Jul 2020

• REC opinion

  Further Information Favourable Opinion