EUCTR2007-007160-19-GB进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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