dose-evaluation study of the efficacy and safety of tla gut™ leukapheresis treatment in patients with ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: an open-label, randomised, multi-centre, dose evaluation study of the efficacy and safety of tla gut™ leukapheresis treatment in patients with uc. the aim of this trial is to evaluate the efficacy and safety of two different tla gut™ dose regimens in patients with acute exacerbation of uc. enrolled patients will participate in a 6-week treatment phase and a 20- week follow-up phase. the treatment phase consists of two periods; 2 weeks in which patients will undergo two treatment sessions per week, followed by 4 weeks of a single treatment session per week. the follow-up phase consists of 2 visits, one visit at week 7 and the last visit at week 26. telephone visits will be conducted between these visits. in all a patient will undergo 8 treatment visits and 2 follow-up visits. only patients not having experienced an earlier recurrence will participate in the follow-up phase.


Eligibility criteria:
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 exclusion criteria: involvement in any investigational drug or device trial within 30 days prior to this investigation * patients with peripheral veins not suitable for extracorporeal treatment * fever, defined as a temperature of \>38,5 celsius degrees (ºc), at the screening visit * heart failure * coronary artery disease * cardiomyopathy * valvular heart disease * cardiac arrythmia class iv * underweight person (bmi \< 19) * hypotension (\< 90/55 mmhg) * hypoproteinemia * evidence of toxic megacolon * history of hypersensitivity to heparin * heparin-induced thrombocytopenia * history of cerebrovascular incident * known clinically significant bleeding disorder * colectomy planned within 6 months * concomitant anticoagulant therapy * history of hypercoagulable disorders * severe anaemia or leukopenia * patients with active viral hepatitis and/or human immunodeficiency virus (hiv) infections * a positive urine pregnancy test at the screening visit * patients that are nursing local intestinal treatments with suppositories, enemas, creams, ointments or foams during the last 2 weeks * current daily smoking habits * patients unwilling to meet the requirements of the clinical investigational plan * other medical or social reasons for exclusion at the discretion of the investigator