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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 April 2017
Main ID:  EUCTR2007-002542-38-DK
Date of registration: 08/11/2007
Prospective Registration: Yes
Primary sponsor: Novartis Pharma Services AG
Public title: A clinical study to explore the safe and effective use of the drug sotrastaurin in patients with ulcerative colitis
Scientific title: A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. - A2210
Date of first enrolment: 28/11/2007
Target sample size: 60
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002542-38
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Denmark Germany
Contacts
Name: Klinisk forskningsafdeling   
Address:  Lyngbyvej 172 2100 København Ø Denmark
Telephone: +4539168400
Email: skriv.til@novartis.com
Affiliation:  Novartis Healthcare A/S
Name: Klinisk forskningsafdeling   
Address:  Lyngbyvej 172 2100 København Ø Denmark
Telephone: +4539168400
Email: skriv.til@novartis.com
Affiliation:  Novartis Healthcare A/S
Key inclusion & exclusion criteria
Inclusion criteria:
1. Males and females 18-75 years of age with an established diagnosis of ulcerative colitis are eligible for the study.

2. Female patients of child-bearing potential must be concurrently using two acceptable methods of contraception, (e.g. intra-uterine device plus condom, spermicidal gel plus condom, diaphragma plus condom, etc.) from the time of screening and for the duration of the study, through study completion and for 1 month following study completion.

3. Patients must have active, moderate to severe disease with a Partial Mayo Score between 5 and 10 (inclusive), with a score of at least 2 on either stool frequency or rectal bleeding and a Modified Baron Score of at least 2 upon endoscopic examination with the disease extending at least 25 cm from the anal verge.

4. Patients must have responded poorly to conventional therapy. Poor response is considered to be any of the following:

the continuous requirement for intermittent, oral steroid therapy of more than 20 mg methylprednisolone or equivalent per day for more than 3 months (including steroid dependence defined as relapse within 3 months after stopping).

the requirement for = 2 g mesalamine per day.

the failure to remain symptom-free on maintenance medication of azathioprine or 6-
mercaptopurin (an adequate course is considered to be at least 12 weeks of treatment).

Patients that do not tolerate mesalamine or steroid therapy will also be included. Doses of steroids and mesalamine, where topical therapy is not allowed, will be frozen at the time of screening and may be continued unchanged. The maximum allowed daily steroid dose is 20 mg methylprednisolone (or equivalent steroid dose). Other maintenance medications like azathioprine or 6-mercaptopurin will be continued unchanged throughout the study period.

5. Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study and to understand and sign written informed consent.
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:
1. Previous treatment with biologics (e.g. anti TNF-a) within the last 3 months or use of any other investigational drug within the previous 1 month.

2. Hypersensitivity to AEB071 compound.

3. Weight of less than 50 kg or more than 150 kg.

4. Ongoing treatment with antibiotics, cyclosporine, methotrexate, tacrolimus or rectally administered corticosteroid or 5-aminosalicylate containing medication. Eligible patients must have stopped cyclosporine, methotrexate and tacrolimus at least 8 weeks and antibiotics and rectal topical therapy at least 2 weeks prior to study entry.

5. Patients with active or history of clinically significant cardiac abnormalities, for example:

Patients requiring drugs with QT-prolonging properties (e.g. antiarrhythmic drugs, such as amiodarone, sotalol, dofetilide, quinidine, procainamide, disopyramide).

Patients with sustained heart rate <50 bpm or >90 bpm after resting in supine position for 5 minutes.

Patients with hypokalemia, QTc >470msec, long QT-syndrome (own or with a family history) or with a family history of sudden unexplained death. •Patients with implanted cardiac pacemaker or defibrillator.

Patients with left branch bundle block (LBBB), and patients with known history of congestive heart failure (NYHA class II to IV) or known left-ventricular dysfunction (LVEF < 45%).

History of tachyarrhythmia e.g., supraventricular tachycardia, atrial flutter, atrial fibrillation, ventricular tachycardia, ventricular flutter, ventricular fibrillation.

History of myocardial infarction within the previous 12 months; uncontrolled or unstable angina pectoris.

History of syncope.

6. Patients who are requiring the administration of strongly interacting drugs of the CYP450 3A4/5 system (See Appendix 6).

7. Positive results for the detection of enteropathogens (including Salmonella, Yersinia, Shigella, Camplylobacter, EHEC and C. difficile).

8. Laboratory findings showing:

Aspartate aminotransferase, alanine aminotransferase and bilirubin higher than 3 times the upper limit of normal,

Alkaline phosphatase higher than 2 times the upper limit of normal,

Absolute neutrophil count of <1,500/mm3, an absolute leukocyte count <2,500/mm3 or platelets <75,000/mm3.

9. Patients who have been diagnosed with primary sclerosing cholangitis are excluded from the study.

10. History of renal trauma, glomerulonephritis or patients with one kidney. Presence of clinically significant proteinuria, active sediments, casts or WBCs in urine.

11. Clinical signs and symptoms of toxic megacolon.

12. Presence or history of major chronic inflammatory autoimmune diseases, e.g. SLE.

13. History of alcohol or drug abuse.

14. Pregnant or breastfeeding women are excluded.

15. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.

16. Administration of live vaccines within 6 months prior to dosing.

17. A positive HIV (ELISA and Western blot) test result, Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

18. Significant illness within the two weeks prior to dosing or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.

19. History of malignancy (other than basal cell carcinoma or adequately treated carcinoma-in-situ of the cervix).

20. Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, he


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative colitis
MedDRA version: 14.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Intervention(s)

Product Name: Sotrastaurin
Product Code: AEB071
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sotrastaurin (INN) acetate
CAS Number: 425637-18-9
Current Sponsor code: AEB071
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100 -mg
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: Vitamin B2
Pharmaceutical Form: Tablet
INN or Proposed INN: Riboflavin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-mg

Primary Outcome(s)
Main Objective: Evaluate the efficacy of sotrastaurin (AEB071) in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids.
Primary end point(s): The primary endpoint is clinical remission 4 weeks after treatment initiation, defined as a Modified Baron Score of 0 or 1 and a Partial Mayo Score of 0 or 1.
Secondary Objective: Evaluate the safety, tolerability and pharmacokinetics of sotrastaurin (AEB071) given as an oral drug at 300 mg for two weeks twice a day followed by 200 mg for two weeks twice a day in ulcerative colitis patients.

Explore the relationship between sotrastaurin (AEB071) pharmacokinetics, clinical efficacy outcomes, pharmacodynamic markers and potential biomarkers.
Timepoint(s) of evaluation of this end point: Clinical remission 4 weeks after treatment initiation
Secondary Outcome(s)
Secondary end point(s): Change from baseline in partial Mayo score 4 weeks after treatment initiation
Timepoint(s) of evaluation of this end point: week 4
Secondary ID(s)
CAEB071A2210
Source(s) of Monetary Support
Novartis Pharma Services AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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