ENTRANCE: SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease

Sponsor

4SC AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00820365

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease (IBD)	Drug: SC12267 (4SC-101)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Tokuda Hospital Gastroenterology Division Internal Medicine Department	Sofia	Bulgaria	1407
2	UMHAT "Sv. Ivan Rilski" Gastroenterology Clinic	Sofia	Bulgaria	1431
3	UMHAT "Tsaritsa Ioanna" - ISUL Gastroenterology Clinic	Sofia	Bulgaria	1527
4	Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum	Berlin	Germany
5	Klinikum der Ruhr-Universität Bochum, St. Josef-Hospital, I. Medizinische Klinik	Bochum	Germany
6	Universitätsklinikum Freiburg, Gastroenterologie, Hepatologie, Endokrinologie und Klinische Infektiologie	Freiburg	Germany
7	Schwerpunktpraxis für chronisch entzündliche Darmerkrankungen	Hamburg	Germany
8	Gastroenterologische Gemeinschaftspraxis Herne	Herne	Germany
9	Universitätsklinikum Schleswig-Holstein Campus Lübeck	Lübeck	Germany
10	Technische Universität München II. Medizinische Klinik des Klinikums rechts der Isar	München	Germany
11	Gastroenterologische Gemeinschaftspraxis am Germania-Campus	Münster	Germany
12	Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin I	Regensburg	Germany
13	Robert-Bosch-Krankenhaus Stuttgart	Stuttgart	Germany	70376
14	Elias University Emergency Hospital	Bucuresti	Romania	011461
15	Colentina Clinical Hospital	Bucuresti	Romania	020125
16	University Emergency Hospital	Bucuresti	Romania	050098