Inflammatory Bowel Disease (IBD)
Conditions
Keywords
Inflammatory Bowel Disease (IBD), Crohn's Disease, Ulcerative Colitis, SC12267, 4SC-101, Phase II
Brief 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.
Interventions
Peroral administration of SC12267 (4SC-101) in patients with Inflammatory Bowel Disease over 12 weeks.
Sponsors
4SC AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 \<8.5 g/dl, 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 (\>=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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of SC12267 (4SC-101) at a dose of 35 mg once daily in patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) after a 12 week therapy as measured by the number of patients with complete or partial response. | after a 12 week therapy |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to evaluate the safety and tolerability of SC12267 (4SC-101) at a dose of 35 mg once daily in patients with CD or UC and to explore plasma levels (trough values) of SC12267 (4SC-101). | after a 12 week therapy |
Countries
Bulgaria, Germany, Romania
Outcome results
None listed