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

Inflammatory Bowel Disease (IBD) Clinical Trial

— ENTRANCE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820365
• Other study ID #: SC12267-4-2008
• Secondary ID: EudraCT-Number:
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2009
• Last updated: May 17, 2011
• Start date: March 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: 4SC AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBulgaria: Bulgarian Drug AgencyRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• SC12267 (4SC-101)
Peroral administration of SC12267 (4SC-101) in patients with Inflammatory Bowel Disease over 12 weeks.

Locations

Country	Name	City	State
Bulgaria	Tokuda Hospital Gastroenterology Division Internal Medicine Department	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski" Gastroenterology Clinic	Sofia
Bulgaria	UMHAT "Tsaritsa Ioanna" - ISUL Gastroenterology Clinic	Sofia
Germany	Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum	Berlin
Germany	Klinikum der Ruhr-Universität Bochum, St. Josef-Hospital, I. Medizinische Klinik	Bochum
Germany	Universitätsklinikum Freiburg, Gastroenterologie, Hepatologie, Endokrinologie und Klinische Infektiologie	Freiburg
Germany	Schwerpunktpraxis für chronisch entzündliche Darmerkrankungen	Hamburg
Germany	Gastroenterologische Gemeinschaftspraxis Herne	Herne
Germany	Universitätsklinikum Schleswig-Holstein Campus Lübeck	Lübeck
Germany	Technische Universität München II. Medizinische Klinik des Klinikums rechts der Isar	München
Germany	Gastroenterologische Gemeinschaftspraxis am Germania-Campus	Münster
Germany	Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin I	Regensburg
Germany	Robert-Bosch-Krankenhaus Stuttgart	Stuttgart
Romania	Colentina Clinical Hospital	Bucuresti
Romania	Elias University Emergency Hospital	Bucuresti
Romania	University Emergency Hospital	Bucuresti

Sponsors (1)

Lead Sponsor	Collaborator
4SC AG

Countries where clinical trial is conducted

Bulgaria,  Germany,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes