SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel Disease (IBD)
- Registration Number
- NCT00820365
- Lead Sponsor
- 4SC AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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
- unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
- 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
- unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
- 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:
-
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
-
a method of second choice like condom, diaphragm, or cup pessary
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (16)
Schwerpunktpraxis für chronisch entzündliche Darmerkrankungen
🇩🇪Hamburg, Germany
Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin I
🇩🇪Regensburg, Germany
University Emergency Hospital
🇷🇴Bucuresti, Romania
Robert-Bosch-Krankenhaus Stuttgart
🇩🇪Stuttgart, Germany
Tokuda Hospital Gastroenterology Division Internal Medicine Department
🇧🇬Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski" Gastroenterology Clinic
🇧🇬Sofia, Bulgaria
UMHAT "Tsaritsa Ioanna" - ISUL Gastroenterology Clinic
🇧🇬Sofia, Bulgaria
Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
Klinikum der Ruhr-Universität Bochum, St. Josef-Hospital, I. Medizinische Klinik
🇩🇪Bochum, Germany
Universitätsklinikum Freiburg, Gastroenterologie, Hepatologie, Endokrinologie und Klinische Infektiologie
🇩🇪Freiburg, Germany
Gastroenterologische Gemeinschaftspraxis Herne
🇩🇪Herne, Germany
Gastroenterologische Gemeinschaftspraxis am Germania-Campus
🇩🇪Münster, Germany
Technische Universität München II. Medizinische Klinik des Klinikums rechts der Isar
🇩🇪München, Germany
Colentina Clinical Hospital
🇷🇴Bucuresti, Romania
Elias University Emergency Hospital
🇷🇴Bucuresti, Romania