A double blind, randomized, placebo controlled, multicenter, dose finding study of oral AEB071 assessing Psoriasis Area and Severity Index (PASI) respoonse as a function of dose and treatment duration (primary outcome) in patients with plaque psoriasis - CAEB071C2201
- Conditions
- Plaque psoriasis diagnosed for at least 12 months with or without psoriatic arthritisMedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
- Registration Number
- EUCTR2007-007160-19-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Men and women, between 18 and 75 years of age, inclusive at time of consent.
2. Moderate to severe plaque psoriasis diagnosed for at least 12 months (with or without presence of psoriatic arthritis as a comorbidity) requiring systemic therapy
3. Severity of disease meeting ALL of the following three criteria:
- Psoriasis Area and Severity Index (PASI) score of 10 or greater
- Total Body Surface Area (BSA) of 10% or greater affected by plaque psoriasis
- Investigator’s Global Assessment (IGA) score of 3 or greater
4. Patients must be able to communicate with the investigator and comply with the
requirements of the study and must give written informed consent before any asessment is performed.
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
1. Hematological abnormalities i.e., leucocytes (total WBC) < 4.000/mm3,
neutrophils/granulocytes (ANC/AGC) < 1.500/mm3, lymphocytes < 1000/mm3, platelets < 100.000/mm3, hemoglobin < 10 g/dL at screening
2. Heart rate < 50 or > 90 bpm when resting for 5 mins
3. Family history of long QT syndrome, or QTcF > 470 msec at baseline
4. History of tachyarrhythmia as defined by protocol.
5. History of conduction abnormality as defined by protocol.
6. Uncontrolled or unstable angina pectoris; history of myocardial infarction within previous 12 mths
7. Known history of congestive heart failure or known LVEF < 45%
8. History of percutaneous coronary intervention (PCI) or cardiac ablation
9. History of syncope
10. History of stroke or transient ischemic attack (TIA)
11. Implanted cardiac pacemaker or defibrillator
12. History of major gastrointestinal surgery
13. Evidence of being PPD+ with confirmatory chest X-ray indicating active/inactive
tuberculosis at screening
14. Serum potassium level outside normal range
15. Known to be immunocompromised or positive HIV test result at screening
16. Positive hepatitis B or hepatitis C test result at screening
17. Abnormalities in liver function tests as defined in protocol.
18. Active systemic infections within the past 2 weeks other than common cold
19. History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases
20. Current guttate, generalized erythrodermic, or pustular psoriasis (symptoms of inverse psoriasis are allowed as long as plaque psoriasis is predominant)
21. Current drug associated psoriasis as defined in the protocol.
22. History of drug or alcohol abuse within the 12 months prior to screening
23. Hypersensitivity to AEB071 or any ingredient of study drug
24. Any significant medical condition the severity of which prevents the patient from
participating in this study according to investigators assessment
25. Use or planned use of prohibited treatments/medications within the period specified in protocol
26. Body weight below 45 kg
27. Donation or loss of 400 ml or more blood within 8 weeks prior to first dosing
28. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL)
29. Women of childbearing potential (including women who have had a bilateral tubal ligation) unless they are using highly effective methods of contraception.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method