A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

• Conditions: Chronic active treatment refractory ulcerative colitis; MedDRA version: 16.1Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-003130-14-CZ
• Lead Sponsor: InDex Pharmaceuticals AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-14
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male or female = 18 years of age.
2. Well established diagnosis of moderate to moderately severe chronic active UC with a CAI score =9, an endoscopic score =2, not responding adequately to currently available therapies and potential candidates for colectomy. Previously tried therapies should include:
• At least one treatment course with mesalazine; at least 2.4 g/day for at least 4 weeks, or at least one treatment course with similar drugs in this class.
• At least one full dose treatment course of corticosteroids (which can be the treatment of a recent relapse), with up to 0.75 mg/kg as a starting dose or highest dose according to local clinical practice.
• At least one treatment course of azathioprine or mercaptopurine of at least 3 months duration and/or at least one adequate treatment course of an anti-TNF alpha.
• Any unsuccessful combination treatment of the above.
• May have tried treatment with cyclosporine and/or tacrolimus or any other
immunosuppressant/immunomodulating agent.
• Intolerance to any of the above medications corresponds to inadequate response.
3. Patients shall at study enrolment be on an accumulated stable tolerable GCS dose
equivalent to at least 140 mg of prednisolone/prednisone (by any route of administration) for the last two weeks. Patients may also be on concomitant therapies such as, but not restricted to, 5-ASA, azathioprine and sulphasalazine.
4. Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Patients with suspicion of Crohn’s enterocolitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, as well as microscopic colitis should be excluded. Patients with disease limited to the rectum (ulcerative proctitis) should also be excluded.
2. History or presence of a clinically significant cardiovascular, hepatic, renal,
haematological, endocrine, neurological, psychiatric disease, or immune compromised state as judged relevant by the investigator.
3. Patients with acute fulminant UC and/or signs of systemic toxicity to an extent that
requires immediate surgical action.
4. History or presence of any colonic malignancy and/or dysplasia.
5. Concomitant treatment with cyclosporine, tacrolimus, anti-TNFs or similar immunosuppressants/immunomodulators is not allowed and should have been
discontinued 4 weeks before enrolment. Patients who fail the wash-out criteria can
undergo wash-out and be re-screened at a later time point.
6. Treatment with antibiotics or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within two weeks before enrolment.
7. An active ongoing infection.
8. Positive Clostridium difficile stool assay.
9. Currently receiving parenteral nutrition or blood transfusions.
10. Pregnancy or breast-feeding.
11. Women of childbearing potential not using reliable contraceptive methods (reliable methods are barrier protection, hormonal contraception, intra-uterine device or abstinence) throughout the duration of the study (52 weeks).
12. Concurrent participation in another clinical study with investigational therapy or previous
use of investigational therapy within 30 days before enrolment. Patients who fail the
wash-out criteria can undergo wash-out and be re-screened at a later time point.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the induction of clinical remission with Kappaproct given as an add-on treatment<br>in two doses of 30 mg each compared to placebo.;Secondary Objective: • To evaluate the rate of colectomy with Kappaproct given as an add-on treatment in<br>two doses of 30 mg each compared to placebo.<br>• To evaluate the induction and maintenance of steroid-free remission.<br>• To evaluate safety and tolerability.;Primary end point(s): The induction of clinical remission at week 12, defined as a CAI score of =4.;Timepoint(s) of evaluation of this end point: Refer to E.5.1