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Ulcerative Colitis (UC)NCT04550130

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

A study testing TLA Gut™ in people with Ulcerative Colitis (UC), run by TLA, Targeted Immunotherapies AB at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
TLA Gut™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSweden
Study dates
Dec 2022to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country.

Sweden1 site, 1 recruiting

  • Ersta Sjukhus, Medicinkliniken

    Stockholm, 116 91

    TLA, TLA, purchasing@ithgroup.se

    Recruiting

Other trials in Sweden

About this study

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

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.

Being tested
TLA Gut™
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TLA Gut™Device

    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.

Study groups in NCT04550130
Study groupRoleWhat they receive
low dose (1.8 L)ExperimentalPatients in this arm will be treated with one column (Leukapheresis) and 1.8 L blood will be filtered.
Receives: Device: TLA Gut™
high dose (3.6 L)ExperimentalPatients in this arm will be treated with Two column (Leukapheresis) and 3.6 L blood will be filtered.
Receives: Device: TLA Gut™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate whether the intervention of TLA Gut™ reduces Human Leukocyte Antigen DR isotype (HLADRhi)

    Mean percentage change in HLA-DRhi expressing monocytes

    Measured: baseline, during treatment (after 4 treatment sessions at week 2)

Secondary outcomes (7)

  1. Evaluate the effect of intervention of TLA Gut™ on clinical, histopathology and laboratory criteria and variables

    Mean change in HLA-DRhi expressing monocytes

    Measured: baseline, during treatment (after 4 treatment sessions at week 2)

  2. Evaluate the effect of intervention of TLA Gut™ on clinical variables

    Mean change and mean percentage change in Mayo Score Index

    Measured: baseline, after 4 treatment sessions at week 2 , immediately after treatment completion

  3. Evaluate the effect of intervention of TLA Gut™ on laboratory criteria

    Mean percentage change in faecal calprotectin levels

    Measured: baseline, during treatment (at week 6), immediately after treatment completion

  4. Evaluate the effect of intervention of TLA Gut™ on clinical, histopathology and laboratory criteria and variables

    Proportion of patients in each dosing group achieving laboratory remission, clinical remission or both laboratory and clinical remission

    Measured: immediately after treatment completion

  5. Evaluate the effect of intervention of TLA Gut™ on clinical variables

    Proportion of patients in each dosing group classified as responders

    Measured: immediately after treatment completion

  6. Evaluate the effect of intervention of TLA Gut™ on clinical variables

    Mean change and mean percentage change in Mayo Endoscopic Sub-Score Index

    Measured: baseline, after 4 treatment sessions at week 2 , immediately after treatment completion

  7. Evaluate the effect of intervention of TLA Gut™ on clinical variables

    Mean change and mean percentage change in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score

    Measured: baseline, after 4 treatment sessions at week 2 , immediately after treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study startDec 2022 (estimated)
  3. Primary completionApr 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04550130
Sponsor's protocol ID
TLA002
Status last verified
Nov 2022
First submitted
9 Apr 2020
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TLA Gut™ in people with Ulcerative Colitis (UC), run by TLA, Targeted Immunotherapies AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate whether the intervention of TLA Gut™ reduces Human Leukocyte Antigen DR isotype (HLADRhi) (time frame: baseline, during treatment (after 4 treatment sessions at week 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04550130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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