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

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