Mild to moderate Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
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 (rFXII
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;Primary end point(s): Endoscopic remission defined as a modified Baron score of 0;Timepoint(s) of evaluation of this end point: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Bulgaria, Croatia, Denmark, European Union, Hungary, Russian Federation, Ukraine
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed