Aurinia Renal Response in Active Lupus With Voclosporin
关键词
抽象
描述
The aim of the current study is to investigate whether voclosporin, added to the standard of care treatment in active lupus nephritis (LN), is able to reduce disease activity over a treatment period of 52 weeks. The background therapy will be MMF and initial treatment with IV methylprednisolone, followed by a reducing course of oral corticosteroids. Subjects with active, flaring LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria (as measured by urine protein/creatinine ratio (UPCR)) while demonstrating an acceptable safety profile.
日期
| 最后验证: | 10/31/2019 |
| 首次提交: | 01/11/2017 |
| 提交的预估入学人数: | 01/12/2017 |
| 首次发布: | 01/15/2017 |
| 上次提交的更新: | 11/18/2019 |
| 最近更新发布: | 11/19/2019 |
| 实际学习开始日期: | 05/16/2017 |
| 预计主要完成日期: | 09/23/2019 |
| 预计完成日期: | 10/09/2019 |
状况或疾病
干预/治疗
Drug: Voclosporin
Drug: Placebo Oral Capsule
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Voclosporin oral, 23.7 mg BID | Drug: Voclosporin calcineurin inhibitor |
| Placebo Comparator: Placebo Oral Capsule Voclosporin placebo, oral, 3 capsules BID | Drug: Placebo Oral Capsule matching placebo capsule |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Key Inclusion Criteria: - Subjects with evidence of active nephritis, defined as follows: - Kidney biopsy result within 2 years prior to screening indicating Class III, IV-S, IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater increase of UPCR within the last 6 months to a minimum of ≥1.5 mg/mg for Class III/IV or to a minimum of ≥2 mg/mg for Class V at screening. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility. OR - Kidney biopsy result within 6 months prior to screening indicating Class III, IV-S or IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening. OR - Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of ≥2 mg/mg at screening. - Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. Exclusion Criteria: - Estimated glomerular filtration rate (eGFR) of ≤45 mL/minute at screening. - Current or medical history of: - Congenital or acquired immunodeficiency. - In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening. - Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. - Lymphoproliferative disease or previous total lymphoid irradiation. - Severe viral infection or known HIV infection. - Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid. - Other known clinically significant active medical conditions, such as: - Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary disease or asthma requiring oral steroids or any other overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes. |
结果
主要结果指标
1. The number of subjects achieving renal response [52 Weeks]
次要成果指标
1. Time to UPCR of ≤0.5 mg/mg. [52 Weeks]
2. Partial renal response [Weeks 24 and 52]
3. Time to 50% reduction in UPCR from baseline. [52 Weeks]
4. Renal response at Week 52 [52 Weeks]
5. Duration of renal response [52 Weeks]
6. Change from baseline in laboratory parameters at each time point [52 Weeks]
7. Renal response with low-dose steroids [52 Weeks]
8. Quality of Life questionnaires [Weeks 12, 24 and 52]
9. Change from baseline in the SELENA-SLEDAI Index score [Weeks 24 and 52]
