A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a treatment of a novel leukapheresis column is safe and effective in patients with moderate to severe ulcerative colitis.

Detailed Description
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Ulcerative colitis (UC) is a chronic and relapsing disease and is characterized by superficial inflammation in the colonic epithelium. The inflammation is maintained by continuous supply of inflammatory cells from the circulating blood to the intestinal mucosa. Existing therapy e.g. corticosteroids and immunosuppressants are inadequate with an overall long-term remission rate of only 50-60%. Those treatments are also associated with severe side effects why there is a need of new therapies. The aim of this study is to investigate a novel leukapheresis treatment with the potential to reduce the number of inflammatory cells homing to the gut mucosa. By drawing blood from the patient and pass it through the investigational column the inflammatory cells are removed. The blood, depleted of the inflammatory cells, is returned to the patient. The treatment thus enable down-regulation of the inflammation and consequently the inflammation can heal. The treatment is called Tailored leukapheresis.

Official Title
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A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Device: Active TLA Gut™ column
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis. Exclusion criteria; Local intestinal treatments with suppositories, enemas or clysmas during the last 4 weeks Current daily smoking habits Other severe diseases as detailed in the protocol History of hypersensitivity to heparin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active TLA Gut™ column<br>The active column contain an engineered protein with the ability to specifically bind the inflammatory cells. | Device: Active TLA Gut™ column<br>* Five consecutive treatment sessions. The therapy will be administrated every second day.<br>* Other names: TLA Gut™;|
| Placebo Comparator: Placebo TLA Gut™column<br>The placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells. | Device: Placebo<br>* Five consecutive treatment sessions. The placebo therapy will be administrated every second day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression level of MHC class II on antigen presenting cells. | The primary outcome will be assessed by flow cytometry. | change from baseline at day 5, 12, 28, 42 and 98. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of cells and/or expression level of gut homing and activation markers on lymphocytes and monocytes. Safety and tolerability. Clinical effect on signs and symptoms of the disease. | The immunological analysis will be peformed by flow cytometry. The safety will be measured by recording adverese events at each visit. The disease activity will be assessed by using the Mayo Score Questionnaire. | change from baseline at day 5, 12,28, 42, 98. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, leukapheresis treatment