A Phase III, Randomized, Multicentre, Double-Blind, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients

Aurinia Pharmaceuticals Inc.1 个研究点分布在 1 个国家目标入组 642 人2006年12月

适应症Psoriasis

干预措施voclosporin Placebo Ciclosporin

相关药物voclosporin Ciclosporin Placebo

概览

阶段: 3 期
干预措施: voclosporin
疾病 / 适应症: Psoriasis
发起方: Aurinia Pharmaceuticals Inc.
入组人数: 642
试验地点: 1
主要终点: Superiority in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score
状态: 已完成
最后更新: 16年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.

详细描述

Psoriasis is a chronic skin condition that can have a significant impact on a patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet ciclosporin, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as ciclosporin A, but also has an improved toxicity profile.

注册库

clinicaltrials.gov

开始日期

2006年12月

结束日期

2008年12月

最后更新

16年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Aurinia Pharmaceuticals Inc.

入排标准

入选标准

•Aged greater than or equal to 18 years of age inclusive at time of screening.
•Diagnosed with plaque psoriasis greater than or equal to 6 months prior to screening.
•Diagnosis of stable, plaque psoriasis; i.e. psoriasis must not be spontaneously improving or worsening in the 4 weeks prior to the screening visit.
•Psoriasis failing at least one systemic treatment regimen or where other systemic therapies are contraindicated or where tolerability is an issue.
•Plaque psoriasis involving greater than or equal to 10% of the body surface area and a SPGA score greater than or equal to 3 at screening and prior to randomization at the day 0 visit.
•Not pregnant or nursing.
•Sexually active women of childbearing potential or less than 1 year post-menopausal and sexually active men who are not surgically sterile must use a reliable form of birth control during study treatment and for at least 3 months after the last dose of study drug. Surgically sterile females are not considered to be of childbearing potential. Reliable forms of birth control include oral or depot contraceptives, and double-barrier methods.
•Written informed consent prior to washout and screening procedures.
•Able to keep study appointments and cooperate with all study requirements, in the opinion of the Investigator.

排除标准

•Has generalized erythrodermic, guttate, or pustular psoriasis.
•Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the Investigator.
•A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.
•Has a current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals or has had such infections within 60 days prior to screening.
•A known history of tuberculosis.
•Serologic evidence or known latent HIV, HBV or HCV virus.
•Uncontrolled hypertension of systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 90 mmHg.
•MDRD GFR \< 60 mL/min.
•Variation between the screening and Visit 1 SCr greater than or equal to 30%.
•ALT, AST, GGT greater than or equal to 2x upper limit of normal (ULN).

研究组 & 干预措施

1.

干预措施: voclosporin

3.

干预措施: Placebo

2.

干预措施: Ciclosporin

结局指标

主要结局

Superiority in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score

时间窗: Twelve weeks of treatment

次要结局

To show non-inferiority of voclosporin compared to ciclosporin in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score at(Twelve weeks of treatment)
Superiority in de novo hypertriglyceridemia, defined as proportion of patients developing fasting triglycerides greater than or equal to 1.7 mmol/L(Twenty four weeks of treatment)
Superiority in de novo hypertension, defined as proportion of patients developing blood pressure greater than or equal to 140 mmHg (systolic) or greater than or equal to 90 mmHg (diastolic)(Twenty four weeks of treatment)
Superiority of renal function, defined as the proportion of patients experiencing a confirmed greater than or equal to 30% rise in serum creatinine(Twenty four weeks of treatment)
Superiority in proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI-75)(Twelve weeks of treatment)