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

NCT ID: NCT00820365

Last Updated: 2011-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-03-31

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) 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.

Conditions

Inflammatory Bowel Disease (IBD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SC12267 (4SC-101)

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

4SC AG

INDUSTRY

Sponsor Role: lead

Responsible Party

4SC AG

Principal Investigators

Klaus Herrlinger, Prof.

Role: PRINCIPAL_INVESTIGATOR

Robert Bosch Krankenhaus, Stuttgart, Germany

Locations

Tokuda Hospital Gastroenterology Division Internal Medicine Department

Sofia, , Bulgaria

UMHAT "Sv. Ivan Rilski" Gastroenterology Clinic

Sofia, , Bulgaria

UMHAT "Tsaritsa Ioanna" - ISUL Gastroenterology Clinic

Sofia, , Bulgaria

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 im Breisgau, , 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

Elias University Emergency Hospital

Bucharest, , Romania

Colentina Clinical Hospital

Bucharest, , Romania

University Emergency Hospital

Bucharest, , Romania

Countries

Bulgaria; Germany; Romania

References

Herrlinger KR, Diculescu M, Fellermann K, Hartmann H, Howaldt S, Nikolov R, Petrov A, Reindl W, Otte JM, Stoynov S, Strauch U, Sturm A, Voiosu R, Ammendola A, Dietrich B, Hentsch B, Stange EF. Efficacy, safety and tolerability of vidofludimus in patients with inflammatory bowel disease: the ENTRANCE study. J Crohns Colitis. 2013 Sep;7(8):636-43. doi: 10.1016/j.crohns.2012.09.016. Epub 2012 Oct 16.

Reference Type: DERIVED

PMID: 23078909 (View on PubMed)

Kulkarni OP, Sayyed SG, Kantner C, Ryu M, Schnurr M, Sardy M, Leban J, Jankowsky R, Ammendola A, Doblhofer R, Anders HJ. 4SC-101, a novel small molecule dihydroorotate dehydrogenase inhibitor, suppresses systemic lupus erythematosus in MRL-(Fas)lpr mice. Am J Pathol. 2010 Jun;176(6):2840-7. doi: 10.2353/ajpath.2010.091227. Epub 2010 Apr 22.

Reference Type: DERIVED

PMID: 20413687 (View on PubMed)

Other Identifiers

EudraCT-Number: 2008-005903-25

Identifier Type: -

Identifier Source: secondary_id

SC12267-4-2008

Identifier Type: -

Identifier Source: org_study_id