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

Targeted Immunotherapies

Status

Enrolling

Conditions

Ulcerative Colitis (UC)

Treatments

Device: TLA Gut™

Study type

Interventional

Funder types

Industry

Identifiers

NCT04550130

TLA002

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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