CATS29 Crohns Phase IIb, Multicentre, Randomized, Double-blind Study

• Research type

  Research Study

• Full title

  A phase IIb, multicentre, randomized, double-blinded (DB), placebo-controlled, multi-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave® (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29)

• IRAS ID

  157555

• Contact name

  Peter M Irving

• Contact email

  peter.irving@gstt.nhs.uk

• Sponsor organisation

  TxCell

• Eudract number

  2014-001295-65

• Research summary

  CATS29 is planned to be a multicentre (approximately 32 sites in Europe), randomized, double­blinded, placebo controlled, multi­dose and multi­injection study to document the efficacy and expand safety information of Ovasave in Crohn’s disease. Ovasave is not a conventional drug, it is an autologous cell therapy and has the status of Advanced Therapy Medicinal Product. Ovasave will consist of regulatory T cells derived from the participants blood. These cells of interest will be isolated and amplified in vitro before the patients are injected with them. Regulatory T cells are components of the immune system and play an important regulatory and anti­inflammatory role which we feel may be beneficial in relation to Crohn's disease. Patients aged 18­ to 70 years whose disease is currently in active phase and resistant to all conventional treatments will be targeted providing they meet all the eligibility criteria. The sites selected are Gastroenterology Departments which include specialist Crohn’s clinics where the Consultants have good relationship with their patients and from where participants will be selected. The study will consist of a selection period and a 32­Week Follow­up period.
  Patient participation in the study will last approximately 46 weeks and will involve 13 visits in participating in the open label part or 11 visits in case continuing for a follow­up of 16 weeks
  

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  14/LO/1249

• Date of REC Opinion

  26 Sep 2014

• REC opinion

  Further Information Favourable Opinion