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Status:

COMPLETED

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

Lead Sponsor:

4SC AG

Conditions:

Inflammatory Bowel Disease (IBD)

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

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) tabl...

Eligibility Criteria

Inclusion

  • 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 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

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2011

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT00820365

Start Date

March 1 2009

End Date

March 1 2011

Last Update

May 18 2011

Active Locations (16)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

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