E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammatory Bowel Disease |
|
MedDRA Classification |
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 BIAP 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. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· age ³ 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 7-15
or · 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, andchronic 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; · 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 screening 2. 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 baseline 3. probiotics, antibiotics, methotrexate or cyclosporine within 1 month resp. 2 months prior of screening 4. any experimental treatment for this population e.g. infliximab, tacrolimus, FK506 or other anti TNF-α therapy) within 2 months of screening |
|
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 colitis Safety variables Evaluation of circulating antibodies against BIAP, via ELISA Clinical labs (hematology/chemistry incl. cytokines/urine) Vital signs, physical examinations Adverse event monitoring. |
|
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 | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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.8.5 | 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
|
When 24 patients will be enrolled into the study. |
|
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 |