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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2011-003130-14-GB
• Date of registration: 11/08/2011
• Prospective Registration: Yes
• Primary sponsor: InDex Pharmaceuticals AB
• Public title: 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
• Scientific title: A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients
• Date of first enrolment: 06/10/2011
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003130-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, Germany, Hungary, Italy, Poland, United Kingdom

Contacts

• Name: InDex Pharmaceuticals AB
• Affiliation: InDex Pharmaceuticals AB

• Name: InDex Pharmaceuticals AB
• Affiliation: InDex Pharmaceuticals AB

Key inclusion & exclusion criteria

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 treatment course of corticosteroids (which can be the
treatment of a recent relapse), with up to 0.75 mg/kg as 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 trial (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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Kappaproct
Pharmaceutical Form: Rectal solution
Current Sponsor code: DIMS0150
Other descriptive name: DIMS0150
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 15.6-
Pharmaceutical form of the placebo: Rectal capsule
Route of administration of the placebo: Rectal use

Primary Outcome(s)

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

Main Objective: To evaluate the induction of clinical remission with Kappaproct given as an add-on treatment
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
two doses of 30 mg each compared to placebo.
• To evaluate the induction and maintenance of steroid-free remission.
• To evaluate safety and tolerability.

Secondary Outcome(s)

Secondary end point(s): - The time to colectomy.
- The rate of colectomy at 3, 5 and 12 months.
- Steroid free remission at 5 and 12 months.
- The induction of clinical remission at week 12, defined as a CAI score of =4, with
subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1,
respectively.
- The induction of symptomatic remission at week 1, 4, 8 and 12, and the
maintenance of this remission at 5 and 12 months, defined as subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1, respectively.
- The induction of registration remission at week 4 and 12, and the maintenance of this
remission at 5 and 12 months, defined as a CAI score of =4 and an endoscopic score
of 0 or 1.
- The induction of clinical remission at week 1, 4, 8 and the maintenance of this
remission at 5 and 12 months, defined as a CAI score of =4.
- The induction of clinical response at week 1, 4, 8 and 12, defined as a decrease in CAI
score of =5 from baseline.
- Health related quality of life evaluation using an inflammatory bowel disease
questionnaire (IBDQ) and a short-form health survey with 36 questions (SF-36) at
week 12 and at 12 months, compared to baseline.
- The induction of mucosal healing defined as an endoscopic score of 0 or 1 at week 4
• The histopathological response/remission at week 4 and 12. Histopathological
response is defined as an improvement in the histopathological score of =3 from
baseline, i.e. a histopathological response could go from 5 to 2 or from 4 to 1.
Histopathological remission is defined as an improvement from baseline to a histopathological score of 0.
• Frequency of and time to UC relapses, defined as an increase of CAI =5 from the previous study visit.
• Safety and tolerability.

Timepoint(s) of evaluation of this end point: Refer to E.5.2

Secondary ID(s)

CSUC-01/10

Source(s) of Monetary Support

InDex Pharmaceuticals AB

Ethics review

Status: Approved
Approval date:
Contact: