inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0 Level: LLT Classification code 10021973 Term: Inflammatory bowel disease NOS
Conditions
Sponsors
4SC AG
Eligibility
Sex/Gender
All
Inclusion criteria
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] =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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 220 - for ulcerative colitis: CAI > 6 | — |
Countries
Bulgaria, Germany
Outcome results
None listed