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

This study has been completed.
Sponsor:
Information provided by:
4SC AG
ClinicalTrials.gov Identifier:
NCT00820365
First received: January 9, 2009
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by 4SC AG:

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. [ Time Frame: after a 12 week therapy ] [ Designated as safety issue: No ]

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). [ Time Frame: after a 12 week therapy ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: March 2009
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SC12267 (4SC-101)
    Peroral administration of SC12267 (4SC-101) in patients with Inflammatory Bowel Disease over 12 weeks.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 <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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820365

Locations
Bulgaria
UMHAT "Tsaritsa Ioanna" - ISUL Gastroenterology Clinic
Sofia, Bulgaria, 1527
UMHAT "Sv. Ivan Rilski" Gastroenterology Clinic
Sofia, Bulgaria, 1431
Tokuda Hospital Gastroenterology Division Internal Medicine Department
Sofia, Bulgaria, 1407
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, Germany, 70376
Romania
Elias University Emergency Hospital
Bucuresti, Romania, 011461
University Emergency Hospital
Bucuresti, Romania, 050098
Colentina Clinical Hospital
Bucuresti, Romania, 020125
Sponsors and Collaborators
4SC AG
Investigators
Principal Investigator: Klaus Herrlinger, Prof. Robert Bosch Krankenhaus, Stuttgart, Germany
  More Information

No publications provided by 4SC AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Bernhard Hauns, Medical Director Oncology, 4SC AG
ClinicalTrials.gov Identifier: NCT00820365     History of Changes
Other Study ID Numbers: SC12267-4-2008, EudraCT-Number: 2008-005903-25
Study First Received: January 9, 2009
Last Updated: May 17, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency

Keywords provided by 4SC AG:
Inflammatory Bowel Disease (IBD)
Crohn's Disease
Ulcerative Colitis
SC12267
4SC-101
Phase II

Additional relevant MeSH terms:
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on April 16, 2014