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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04550130
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

TLA, Targeted Immunotherapies AB
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis (UC)
Arms & Interventions

Arms

Experimental: low dose (1.8 L)

Patients in this arm will be treated with one column (Leukapheresis) and 1.8 L blood will be filtered.

Experimental: high dose (3.6 L)

Patients in this arm will be treated with Two column (Leukapheresis) and 3.6 L blood will be filtered.

Interventions

Device: - TLA Gut™

The medical device to be investigated is named Tailored Leukapheresis (TLA) Gut™. The device comprises a column that has been designed for extracorporeal leukapheresis to specifically remove chemokine (C-C motif) receptor 9 (CCR9) expressing immunological cell populations including human leukocyte antigen DR isotype (HLA-DRhi ) monocytes from the circulation. This is achieved by integrating a strong affinity binding between the gut homing cell receptor, CCR9, and its cognate ligand, thymus-expressed chemokine (TECK) or chemokine ligand 25 (CCL25). Those blood cells that express CCR9 will bind to presented Biotinylated thymus-engineered chemokine (bTECK) on the matrix by a strong receptor ligand interaction, remaining bound to the matrix. Blood cells that do not express the receptor pass through the column unchanged and are returned to the patient.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ersta Sjukhus, Medicinkliniken, Stockholm, Sweden

Status

Recruiting

Address

Ersta Sjukhus, Medicinkliniken

Stockholm, , 116 91

Site Contact

TLA

purchasing@ithgroup.se

TLA