E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
inflammatory bowel disease (Crohn’s disease and ulcerative colitis) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021973 |
E.1.2 | Term | Inflammatory bowel disease NOS |
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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 |
The primary objective of this study is to explore the efficacy of SC12267 at a dose of 35 mg once daily in patients with IBD after a 12 week therapy as measured by the number of patients with complete or partial response. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to evaluate the safety and tolerability of SC12267 at a dose of 35 mg once daily in patients with IBD and to explore plasma levels (trough values) of SC12267. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Criteria regarding Crohn’s disease 1. Established diagnosis of CD, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray). 2. Patients must be in clinical remission (Crohn’s Disease Activity Index [CDAI] <150 points) on steroid therapy for at least 2 weeks. 3. Confirmed steroid-dependency of CD: patients who are either - unable to taper steroids completely within 3 month of starting steroids, without recurrent active disease, or who have a relapse within 2 months of stopping steroids.. 4. Individual threshold1 dose of previous relapses should be less than 20 mg/day Prednisolone or equivalent steroid dose. 5. Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week.
Criteria regarding ulcerative colitis 6. Established diagnosis of UC, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray). 7. Patients must be in clinical remission (Clinical Activity Index [CAI] <4 points) on steroid therapy for at least 2 weeks. 8. Confirmed steroid-dependency of UC: patients who are either - unable to taper steroids completely within 3 month of starting steroids, without recurrent active disease, or - who have a relapse within 2 months of stopping steroids. 9. Individual threshold* dose of previous relapses should be less than 20 mg/day Prednisolone or equivalent steroid dose. 10. Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week.
Criteria regarding general requirements 11. Men and women, 18 to 70 years of age. 12. Written informed consent. 13. Negative pregnancy test at screening in females of childbearing potential. 14. Males willing to use condoms or to be sexually abstinent. 15. Use of appropriate contraceptive methods for females of childbearing potential one month before, throughout the course of the study and one month after study termination. This must be a combination of the following: 1) a highly effective method of first choice = a method with a low failure rate (i.e. less than 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some Intra Uterine Devices (IUDs), vasectomized partner together with 2) a method of second choice like condom, diaphragm, or cup pessary.
* The threshold dose is that dose at which the patient experienced the relapses. |
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E.4 | Principal exclusion criteria |
Criteria regarding gastrointestinal conditions 16. Short bowel syndrome. 17. Ileostomy, colostomy or rectal pouch. 18. Relapse during screening. Criteria regarding medical history 19. History of or existence of active tuberculosis. 20. History of or existence of urolithiasis. 21. History of or existence of human immune deficiency virus (HIV), Hepatitis B or C. 22. History of malignancy within the past five years (excluding basal cell carcinoma of the skin). 23. Previous opportunistic infection. 24. History of serious drug sensitivity. Criteria regarding concomitant diseases 25. Significant cardiac arrhythmia, bradycardia or tachycardia or any other significant finding in the electrocardiogram (ECG). 26. Congestive heart failure. 27. Uncontrolled arterial hypertension. 28. Uncontrolled asthma. 29. Renal disease. 30. Renal insufficiency defined as glomerular filtration rate (GRF) <50 ml/min/1.73 m² (estimated GRF according to Cockroft-Gault). 31. Psychiatric illness. 32. Known or suspected immunodeficiency. 33. Laboratory abnormalities: hemoglobin <8.5 mg/l, white blood cell count <3500/mm³, platelet count <125 000/mm³, clinically relevant elevation of liver enzymes, serum creatinine level >1.4 mg/dl, hematuria (³10 erythrocytes/field on dipsticks).* * Exception: Females during menstruation. In this case a second examination after the end of menstruation will be performed.
Criteria regarding concomitant circumstances 34. Pregnancy, lactation. 35. History of alcohol and/or drug dependency. 36. Heavy smoking (more than 20 cigarettes per day). 37. Use of prohibited drugs or treatments. 38. Patient not able or not willing to follow study procedures due to physical or psychological limitations or language problems. 39. Participation in another investigational drug or vaccine trial within the last three months or concurrently with this study. 40. Vaccination with life attenuated viruses within 4 weeks prior to study start. 41. Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the trial. 42. Patients possibly dependent on the investigator or the sponsor. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the
Number of patients with response (complete or partial) Complete response: Defined as steroid-free remission at Week 12.
Partial response: Defined as being in remission at any glucocorticoid dose equal or lower than the threshold dose for relapse of the individual patient.
Remission is defined as - for Crohn´s disease: CDAI < 150 - for ulcerative colitis: CAI < 4
Relapse is defined as- for Crohn´s disease: CDAI > 220 - for ulcerative colitis: CAI > 6
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | 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 | Information not present in EudraCT |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | Yes |
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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The end of the study is defined as the last follow up visit of the last patient 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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |