E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild or moderate active ulcerative colitis. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <1% when properly applied and include: combination oral pill, some intra-uterine devices, and a sterilised partner in a stable relationship. Female subjects must also not be actively breast-feeding through the entire study period. • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects. • Ability to co-operate with the investigator and to comply with the requirements of the entire study. • Must be able to understand and voluntarily sign written informed consent prior to inclusion in the study.
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E.4 | Principal 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-TNFα) 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.
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |