sc12267 (4sc-101) for treatment of patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease (IBD)

Summary: this is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16 sites in bulgaria, germany and romania. a total of ca. 30 - 35 patients will receive sc12267 (4sc-101) tablets, 35 mg once daily for 12 weeks. first of all the patients will undergo a screening period of 1 week and a follow-up visit will be performed 4 weeks after study drug discontinuation or earlier in case of relapse during follow up. total study duration will be up to 36 (+2) weeks. there will be 8 study visits: one screening visit, 6 visits during the treatment period and one follow-up visit. in addition, four telephone visits will be performed at week 6, week 10, week 20 (+1) and week 36 (+2). the duration of the entire study (first patient in till last patient out) is expected to be about 13 months.


Eligibility criteria:
inclusion criteria: criteria regarding crohn´s disease: * established diagnosis of cd, confirmed by standard criteria (e.g. endoscopy, ultrasound, x-ray) * patients must be in clinical remission (crohn's disease activity index \[cdai\] \<150 points) on steroid therapy for at least 2 weeks * confirmed steroid-dependency of cd: patients who are either 1. unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or 2. who have a relapse within 2 months of stopping steroids * individual threshold\* dose of previous relapses should be equal or less than 20 mg/day prednisolone or equivalent steroid dose * patients with stable glucocorticosteroid therapy between 20 and 40 mg/day prednisolone or equivalent steroid dose for the previous week criteria regarding ulcerative colitis: * established diagnosis of uc, confirmed by standard criteria (e.g. endoscopy, ultrasound, x-ray) * patients must be in clinical remission (clinical activity index \[cai\] \<4 points) on steroid therapy for at least 2 weeks * confirmed steroid-dependency of uc: patients who are either 1. unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or 2. who have a relapse within 2 months of stopping steroids * individual threshold\* dose of previous relapses should be equal or less than 20 mg/day prednisolone or equivalent steroid dose * patients with stable glucocorticosteroid therapy between 20 and 40 mg/day prednisolone or equivalent steroid dose for the previous week (\* the threshold dose is that dose at which the patient experienced the relapses) criteria regarding general requirements: * men and women, 18 to 70 years of age * written informed consent * negative pregnancy test at screening in females of child-bearing potential * males willing to use condoms or to be sexually abstinent * 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 exclusion criteria: criteria regarding gastrointestinal conditions: * short bowel syndrome * ileostomy, colostomy or rectal pouch * relapse during screening criteria regarding medical history: * history of or existence of active tuberculosis * history of or existence of urolithiasis * history of or existence of human immune deficiency virus (hiv), hepatitis b or c * history of malignancy within the past five years (excluding basal cell carcinoma of the skin) * previous opportunistic infection * history of serious drug sensitivity criteria regarding concomitant diseases: * significant cardiac arrhythmia, bradycardia or tachycardia or any other significant finding in the electrocardiogram (ecg) * congestive heart failure * uncontrolled arterial hypertension * uncontrolled asthma * renal disease * renal insufficiency defined as glomerular filtration rate (grf) \<50 ml/min/1.73 m² (estimated grf according to cockcroft-gault) * psychiatric illness * known or suspected immunodeficiency * laboratory abnormalities: hemoglobin \ =1.4 mg/dl, hematuria (\>=10 erythrocytes/field on dipsticks) criteria regarding concomitant circumstances: * pregnancy, lactation * history of alcohol and/or drug dependence * heavy smoking (more than 20 cigarettes per day) * use of prohibited drugs or treatments * patient not able or not willing to follow study procedures due to physical or psychological limitations or language problems * participation in another investigational drug or vaccine trial within the last three months or concurrently with this study * vaccination with life attenuated viruses within 4 weeks prior to study start * 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 * patients possibly dependent on the investigator or the sponsor

Keywords: inflammatory bowel disease (ibd) crohn's disease ulcerative colitis sc12267 4sc-101 phase ii