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)

• Conditions: inflammatory bowel disease (Crohn’s disease and ulcerative colitis); MedDRA version: 12.0Level: LLTClassification code 10021973Term: Inflammatory bowel disease NOS

• Registration Number: EUCTR2008-005903-25-BG
• Lead Sponsor: 4SC AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Criteria regarding Crohn’s disease
1. Established diagnosis of CD, confirmed by standard criteria
(e.g. endoscopy, ultrasound, X-ray).
2. Patients must be in clinical remission (Crohn’s Disease
Activity Index [CDAI] <150 points) on steroid therapy for
at least 2 weeks.
3. Confirmed steroid-dependency of CD: patients who are
either
- unable to taper steroids completely within 3 month of
starting steroids, without recurrent active disease, or
who have a relapse within 2 months of stopping steroids..
4. Individual threshold1 dose of previous relapses should be
less than 20 mg/day Prednisolone or equivalent steroid
dose.
5. Patients with stable glucocorticosteroid therapy between 20
and 40 mg/day Prednisolone or equivalent steroid dose for
the previous week.

Criteria regarding ulcerative colitis
6. Established diagnosis of UC, confirmed by standard criteria
(e.g. endoscopy, ultrasound, X-ray).
7. Patients must be in clinical remission (Clinical Activity
Index [CAI] <4 points) on steroid therapy for at least 2 weeks.
8. Confirmed steroid-dependency of UC: patients who are
either
- unable to taper steroids completely within 3 month of
starting steroids, without recurrent active disease, or
- who have a relapse within 2 months of stopping steroids.
9. Individual threshold* dose of previous relapses should be
less than 20 mg/day Prednisolone or equivalent steroid
dose.
10. Patients with stable glucocorticosteroid therapy between 20
and 40 mg/day Prednisolone or equivalent steroid dose for
the previous week.

Criteria regarding general requirements
11. Men and women, 18 to 70 years of age.
12. Written informed consent.
13. Negative pregnancy test at screening in females of childbearing
potential.
14. Males willing to use condoms or to be sexually abstinent.
15. 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.

* The threshold dose is that dose at which the patient experienced the relapses.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Criteria regarding gastrointestinal conditions
16. Short bowel syndrome.
17. Ileostomy, colostomy or rectal pouch.
18. Relapse during screening.
Criteria regarding medical history
19. History of or existence of active tuberculosis.
20. History of or existence of urolithiasis.
21. History of or existence of human immune deficiency virus
(HIV), Hepatitis B or C.
22. History of malignancy within the past five years (excluding
basal cell carcinoma of the skin).
23. Previous opportunistic infection.
24. History of serious drug sensitivity.
Criteria regarding concomitant diseases
25. Significant cardiac arrhythmia, bradycardia or tachycardia
or any other significant finding in the electrocardiogram
(ECG).
26. Congestive heart failure.
27. Uncontrolled arterial hypertension.
28. Uncontrolled asthma.
29. Renal disease.
30. Renal insufficiency defined as glomerular filtration rate
(GRF) <50 ml/min/1.73 m² (estimated GRF according to
Cockroft-Gault).
31. Psychiatric illness.
32. Known or suspected immunodeficiency.
33. Laboratory abnormalities: hemoglobin <8.5 mg/l, 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).*
* Exception: Females during menstruation. In this case a second examination after the end of menstruation will be
performed.

Criteria regarding concomitant circumstances
34. Pregnancy, lactation.
35. History of alcohol and/or drug dependency.
36. Heavy smoking (more than 20 cigarettes per day).
37. Use of prohibited drugs or treatments.
38. Patient not able or not willing to follow study procedures
due to physical or psychological limitations or language
problems.
39. Participation in another investigational drug or vaccine trial
within the last three months or concurrently with this study.
40. Vaccination with life attenuated viruses within 4 weeks
prior to study start.
41. 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.
42. Patients possibly dependent on the investigator or the
sponsor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified