Clinical trial NCT04550130: Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis
Official title: An Open-label, Randomised, Multi-centre, Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis (UC)
Lead sponsor: TLA, Targeted Immunotherapies AB
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Evaluate whether the intervention of TLA Gut™ reduces Human Leukocyte Antigen DR isotype (HLADRhi)
timeFrame: baseline, during treatment (after 4 treatment sessions at week 2)
Secondary outcomes:
measure: Evaluate the effect of intervention of TLA Gut™ on clinical, histopathology and laboratory criteria and variables
timeFrame: baseline, during treatment (after 4 treatment sessions at week 2)
measure: Evaluate the effect of intervention of TLA Gut™ on clinical variables
timeFrame: baseline, after 4 treatment sessions at week 2 , immediately after treatment completion
measure: Evaluate the effect of intervention of TLA Gut™ on laboratory criteria
timeFrame: baseline, during treatment (at week 6), immediately after treatment completion
measure: Evaluate the effect of intervention of TLA Gut™ on clinical, histopathology and laboratory criteria and variables
timeFrame: immediately after treatment completion
measure: Evaluate the effect of intervention of TLA Gut™ on clinical variables
timeFrame: immediately after treatment completion
measure: Evaluate the effect of intervention of TLA Gut™ on clinical variables
timeFrame: baseline, after 4 treatment sessions at week 2 , immediately after treatment completion
measure: Evaluate the effect of intervention of TLA Gut™ on clinical variables
timeFrame: baseline, after 4 treatment sessions at week 2 , immediately after treatment completion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta Sjukhus, Medicinkliniken
Study officials:
References: