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

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Device: Active TLA Gut™ column; Device: Placebo

• Registration Number: NCT01097590
• Lead Sponsor: IBD Column Therapies International AB

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active TLA Gut™ column	Active TLA Gut™ column	The active column contain an engineered protein with the ability to specifically bind the inflammatory cells.
Placebo TLA Gut™column	Placebo	The placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	change from baseline at day 5, 12,28, 42, 98.	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.

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden