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Inflammatory Bowel Disease (IBD)Phase 2ENTRANCENCT00820365

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

A Phase 2 study testing SC12267 (4SC-101) in people with Inflammatory Bowel Disease (IBD), run by 4SC AG at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Inflammatory Bowel Disease (IBD)
What is being tested?
SC12267 (4SC-101)
How many people
34 participants
Where
16 sitesin 3 countries
Study dates
Mar 2009to Mar 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

Germany10 sites

  • Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum

    Berlin

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

    Bochum

  • Universitätsklinikum Freiburg, Gastroenterologie, Hepatologie, Endokrinologie und Klinische Infektiologie

    Freiburg im Breisgau

  • Schwerpunktpraxis für chronisch entzündliche Darmerkrankungen

    Hamburg

  • Gastroenterologische Gemeinschaftspraxis Herne

    Herne

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck

    Lübeck

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

    München

  • Gastroenterologische Gemeinschaftspraxis am Germania-Campus

    Münster

  • Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin I

    Regensburg

  • Robert-Bosch-Krankenhaus Stuttgart

    Stuttgart, 70376

Other trials in Germany

Bulgaria3 sites

  • Tokuda Hospital Gastroenterology Division Internal Medicine Department

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski" Gastroenterology Clinic

    Sofia, 1431

  • UMHAT "Tsaritsa Ioanna" - ISUL Gastroenterology Clinic

    Sofia, 1527

Other trials in Bulgaria

Romania3 sites

  • Elias University Emergency Hospital

    Bucharest, 011461

  • Colentina Clinical Hospital

    Bucharest, 020125

  • University Emergency Hospital

    Bucharest, 050098

Other trials in Romania

About this study

Official title: 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)

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.

Read more

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.

Being tested
SC12267 (4SC-101)
Keywords
Inflammatory Bowel Disease (IBD), Crohn's Disease, Ulcerative Colitis, SC12267, 4SC-101, Phase II
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SC12267 (4SC-101)Drug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: after a 12 week therapy

Secondary outcomes (1)

  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).

    Measured: after a 12 week therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionOct 2010
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00820365
Sponsor's protocol ID
SC12267-4-2008
Other IDs
EudraCT-Number: 2008-005903-25
Acronym
ENTRANCE
Status last verified
May 2011
First submitted
9 Jan 2009
Last updated
18 May 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23078909

  • 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.

    PubMed 20413687

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SC12267 (4SC-101) in people with Inflammatory Bowel Disease (IBD), run by 4SC AG at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany, Bulgaria, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: after a 12 week therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00820365, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.

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