Mild or moderate active ulcerative colitis. MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Conditions
Interventions
Product Name: Budesonide-MMX™
Product Code: CB-01-02
Pharmaceutical Form: Tablet
INN or Proposed INN: budesonide
CAS Number: 51333-22-3
Other descriptive name: CB-01-02
Concentration unit: mg milligra
Sponsors
COSMO Technologies Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients fulfilling the following criteria at the screening visit are eligible for participation in the study: • Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months. • Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with Ulcerative Colitis Disease Activity Index (UCDAI) = 4 and = 10 according to Sutherland. • All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment. In addition, all females of child-bearing potential must agree to be completely abstinent or be using an accepted form of contraception throughout the entire study period. Accepted forms of contraception are defined as those with a failure rate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria at screening visit are to be excluded from study participation: • Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line). • Patients with severe ulcerative colitis (UCDAI >10). • Patients with infectious colitis. • Evidence or history of toxic megacolon. • Severe anaemia, leucopaenia or granulocytopaenia. • Use of oral or rectal steroids in the last 4 weeks. • Use of immuno-suppressive agents in the last 8 weeks before the study. • Use of anti-tumour necrosis factor alpha (anti-TNFa) agents in the last 3 months. • Concomitant use of any rectal preparation. • Concomitant use of antibiotics. • Concurrent use of CYP3A4 inducers or CYP3A4 inhibitors. • Patients with verified, presumed or expected pregnancy or ongoing lactation. • Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoural parameters (i.e. 2 x upper limit of normal for ALT, AST, GGT or creatinine). • Patient with severe diseases in other organs and systems. • Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents. • Patients diagnosed with type 1 diabetes. • Patients diagnosed with, or with a family history of glaucoma. • All patients with known hepatitis B, hepatitis C or with human immunodeficiency virus (HIV), according to the local privacy policy. • Participation in experimental therapeutic studies in the last 3 months. (Note: patients who participated in observational only studies are not excluded). • Any other medical condition that in the principal investigator’s opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy and safety of budesonide-MMX™ (CB-01-02) 6 mg and 9 mg oral tablets in patients with active mild or moderate ulcerative colitis, when administered for 8 weeks, and compared to placebo. ;Secondary Objective: To evaluate the clinical efficacy and safety of budesonide-MMX™ (CB 01-02) 6 mg and 9 mg oral tablets in patients with active mild or moderate ulcerative colitis, when administered for 8 weeks, and compared to a daily oral dose of 3 x 3 mg Entocort® capsules. To evaluate the improvement in endoscopic, histological, and bio-humoural parameters, rectal bleeding and in the Inflammatory Bowel Disease-Quality of Life (IBD QoL) questionnaire. ;Primary end point(s): The primary efficacy endpoint is the percentage of patients achieving clinical remission in each of the budesonide MMX™ groups versus the placebo group after 8 weeks of treatment. Clinical remission will be defined as a UCDAI score = 1 point with a score of 0 for rectal bleeding and stool frequency, and = 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance). | — |
Countries
Belgium, Estonia, France, Italy, Latvia, Lithuania, Sweden, United Kingdom
Outcome results
None listed