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

NCT00820365 | Completed Phase 2 DMC

• 2 other identifiers: SC12267-4-2008EudraCT-Number: 2008-005903-25
• Study Type: interventional
• Target: 34
• Locations: 3 countries
• Sites: 16

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)

Keywords

Inflammatory Bowel Disease (IBD); Crohn's Disease; Ulcerative Colitis; SC12267; 4SC-101; Phase II

Outcome Measures

Primary Outcomes (1)

• 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.

  after a 12 week therapy

Secondary Outcomes (1)

• 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).

  after a 12 week therapy

Interventions

SC12267 (4SC-101) DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 4SC AG: lead

Study Sites (16)

Tokuda Hospital Gastroenterology Division Internal Medicine Department

Sofia, 1407, Bulgaria

Location

UMHAT "Sv. Ivan Rilski" Gastroenterology Clinic

Sofia, 1431, Bulgaria

Location

UMHAT "Tsaritsa Ioanna" - ISUL Gastroenterology Clinic

Sofia, 1527, Bulgaria

Location

Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum

Berlin, Germany

Location

Klinikum der Ruhr-Universität Bochum, St. Josef-Hospital, I. Medizinische Klinik

Bochum, Germany

Location

Universitätsklinikum Freiburg, Gastroenterologie, Hepatologie, Endokrinologie und Klinische Infektiologie

Freiburg im Breisgau, Germany

Location

Schwerpunktpraxis für chronisch entzündliche Darmerkrankungen

Hamburg, Germany

Location

Gastroenterologische Gemeinschaftspraxis Herne

Herne, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany

Location

Technische Universität München II. Medizinische Klinik des Klinikums rechts der Isar

München, Germany

Location

Gastroenterologische Gemeinschaftspraxis am Germania-Campus

Münster, Germany

Location

Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin I

Regensburg, Germany

Location

Robert-Bosch-Krankenhaus Stuttgart

Stuttgart, 70376, Germany

Location

Elias University Emergency Hospital

Bucharest, 011461, Romania

Location

Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

University Emergency Hospital

Bucharest, 050098, Romania

Location

Related Publications (2)

• 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.

  PMID: 23078909 DERIVED

• 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.

  PMID: 20413687 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

vidofludimus

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Klaus Herrlinger, Prof.

  Robert Bosch Krankenhaus, Stuttgart, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 12, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2011
• Last Updated: May 18, 2011

Record last verified: 2011-05

Locations

DE (10); RO (3); BU (3)