A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

• Register: EUCTR
• Last refreshed on: 29 July 2013
• Main ID: EUCTR2011-001568-22-HU
• Date of registration: 18/07/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis
• Scientific title: A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis
• Date of first enrolment: 15/01/2013
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001568-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes 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

Countries of recruitment

Bulgaria, Croatia, Denmark, European Union, Hungary, Russian Federation, Ukraine

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
- Male and female subjects between 18 and 64 years of age
- Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening
- Currently receiving oral aminosalicylates at approved doses for at least 6 weeks of at least 2 g/day. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as < 15 cm from the anal verge)
- Requiring hospitalisation for current episode of severe UC
- Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)
- Treatment failures to anti-TNF-a agents (e.g. infliximab, adalimumab)
- Use of immunosuppressant agents (e.g. azathioprine) within 4weeks prior to dosing (Visit 2)
- Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)
- Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)
- Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)
- Currently receiving total parenteral nutrition


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

Health Condition(s) or Problem(s) studied

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

Mild to moderate Ulcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Intervention(s)

Product Name: Recombinant Factor XIII (rFXIII)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Catridecacog
Current Sponsor code: Recombinant factor XIII (rFXIII)
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2500-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): Endoscopic remission defined as a modified Baron score of 0

Timepoint(s) of evaluation of this end point: Week 8

Main Objective: To assess the effects of rFXIII on mucosal healing

Secondary Objective: - To assess effects of rFXIII on clinical disease activity
- To assess the safety of rFXIII
- To assess the pharmacokinetics (PK) of rFXIII by FXIII activity systemically

Secondary Outcome(s)

Secondary end point(s): 1. Disease activity:
- Remission (clinical and endoscopic) defined by a UC-DAI score of = 1 with 0 for
rectal bleeding and 0 for stool frequency and no mucosal friability (modified Baron
score = 1)
2. Safety:
- Number of adverse events (AEs)
3. PK of rFXIII (based on the Berichrom® assay):
- Clearance (CL) and maximal concentration (Cmax) systemically

Timepoint(s) of evaluation of this end point: 1. Disease activity at trial Week 8
2. Safety through trial Week 10
3. PK of rFXIII after a single dose

Secondary ID(s)

NN8717-3946

Source(s) of Monetary Support

Novo Nordisk A/S