E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammatory Blowel Disease |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009900 |
|
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 investigate the safety and tolerability of 7 days of BIAP administration in patients with moderate to severe ulcerative colitis |
|
E.2.2 | Secondary objectives of the trial |
To investigate the efficacy of BIAP in patients with moderate to severe ulcerative colitis |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
age 18 years, and capable of understanding the purpose and risks of the study and have provided a signed and dated written informed consent, and prior to the study baseline, been treated with oral steroid medication, of which 2 weeks on oral prednisone equivalent of at least 40 mg/day, and still have active ulcerative colon disease documented by a MAYO-score of 6-11, and active ulcerative colon disease documented by a MTWSI score of 7-15 or prior to the study baseline, documented clinical inability to decrease or stop the course of oral steroid medication. Patients have been treated for a minimum of 12 weeks, and still have chronic active ulcerative colon disease documented by a MAYO-score of 6-11, and chronic active ulcerative colon disease documented by a MTWSI score of 7-15or prior to the study baseline, been treated with a stable dosage of azathioprine for a minimum of 12 weeks, and have a moderate to severe relapse defined as chronic active ulcerative colon disease documented by a MAYO-score of 6-11, and chronic active ulcerative colon disease documented by a MTWSI score of 7-15 |
|
E.4 | Principal exclusion criteria |
ulcerative colitis, requiring immediate surgical, endoscopic, or radiological intervention; including massive hemorrhage, perforation and sepsis, suppurative complications intra-abdominal or peri-anal abscesses or toxic colon history of large bowel surgery history of serious infections positive stool cultures, including Clostridium Difficile significant organ dysfunction pregnancy, nursing mothers, or women of childbearing potential without appropriate use of contraceptives treatment with 1. an altered dose of any 5-ASA preparation within 4 weeks of screening2. an altered dose of azathioprine or mercaptopurine within 4 weeks of screening stable dosage of immunosuppressives is allowed , or start of azathioprine in the last 3 months prior to baseline3. probiotics, antibiotics, methotrexate or cyclosporine within 1 month resp. 2 months prior of screening4. any experimental treatment for this population e.g. infliximab, tacrolimus, FK506 or other anti TNF- 945; therapy within 2 months of screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate the safety and tolerability of 7 days of BIAP administration in patients with moderate to severe ulcerative colitisSafety variables Evaluation of circulating antibodies against BIAP, via ELISA Clinical labs hematology/chemistry incl. cytokines/urine Vital signs, physical examinations Adverse event monitoring. |
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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 | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |