Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis

Inclusion Criteria

• •Female or male patients 18 to 80 years of age
• •Active UC without Ileorectal anastomosis (IRA)
• •Active UC is defined as:
• •* Total Mayo score of ≥ 6 to 11 points
• •* Flexible rectosigmoidoscopy findings of 2 or 3 (0 inactive disease, 1; mild disease, 2; moderate disease or 3; severe disease)
• •Minimum extension of inflammation 10 cm from anus.
• •Active disease with no medical treatment OR Active disease despite receiving concomitant therapy with one or more of the following agents:
• •* ≤20 mg prednisolone daily. Stable dose ≥1 week prior to the start of the investigation.
• •* 5-Aminosalicylate (5-ASA) agents for ≥4 weeks and stable dose for ≥2 weeks (local or systemic administration)
• •* Rectal administration of corticosteroids in a stable dose for ≥2 weeks
• •* Azathioprine or 6-mercaptopurine for ≥8 weeks or stable dose ≥2 weeks
• •No anti-tumour necrosis factor (TNF) treatment (Adalimumab, Infliximab, Golimumab, Certolizumab), anti-integrin-treatment (vedolizumab), Interleukin (IL)-12/23 inhibitor (Ustekinumab) or Janus Kinase (JAK) treatment (Tofacitinib) during the last 4 weeks prior to entering the study
• •Patients with peripheral veins suitable for extracorporeal treatment - must be examined by the treating apheresis specialist
• •Willing and able to give written informed consent