Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
Ключові слова
Анотація
Опис
The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in LN, for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01). All subjects will continue to receive background therapy of MMF and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter the study. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.
Дати
| Востаннє перевірено: | 07/31/2018 |
| Перший поданий: | 06/24/2018 |
| Орієнтовна реєстрація подана: | 07/12/2018 |
| Опубліковано вперше: | 07/23/2018 |
| Останнє оновлення надіслано: | 08/13/2018 |
| Останнє оновлення опубліковано: | 08/15/2018 |
| Фактична дата початку навчання: | 06/11/2018 |
| Розрахункова дата первинного завершення: | 07/31/2021 |
| Розрахункова дата завершення дослідження: | 07/31/2021 |
Стан або захворювання
Втручання / лікування
Drug: Voclosporin
Drug: Placebo Oral Capsule
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| Experimental: Voclosporin Voclosporin | Drug: Voclosporin Calcineurin inhibitor, oral, 23.7 mg BID |
| Placebo Comparator: Placebo Oral Capsule Placebo | Drug: Placebo Oral Capsule Voclosporin placebo, oral, 3 capsules BID |
Критерії прийнятності
| Вік, придатний для навчання | 18 Years До 18 Years |
| Стать, яка підходить для вивчення | All |
| Приймає здорових добровольців | Так |
| Критерії | Inclusion Criteria: 1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval. 2. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12. 3. Subject is willing to continue taking oral MMF for the duration of the study. Exclusion Criteria: 1. Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study. 2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. 3. A planned kidney transplant within study treatment period. 4. Subjects with any medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes. 5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 6. Vaccines using live organisms, virus or bacterial, while taking the study treatment. |
Результат
Заходи первинного результату
1. Adverse events (AE) profile and routine biochemical and hematological assessments. [36 months]
Заходи вторинного результату
1. Proportion of subjects in renal response [Months 12, 18, 24, 30 and 36]
2. Proportion of subjects in partial renal response [Months 12, 18, 24, 30 and 36]
3. Renal flare as adjudicated by the Clinical Endpoints Committee (CEC). [Up to 37 months]
4. Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) [Months 18, 24 and 36]
5. Change in Urine Protein to Creatinine Ratio (UPCR) [Up to 37 months]
6. Change in estimated glomerular filtration rate (eGFR) [Up to 37 months]
7. Change in urine protein [Up to 37 months]
8. Change in serum creatinine [Up to 37 months]
9. Change in immunology (Complement 3 (C3)) parameters from AURORA 1 baseline. [Up to 37 months]
10. Change in immunology parameters (complement 4 (C4)) from AURORA 1 baseline. [Up to 37 months]
11. Change in immunology parameters (anti-double-stranded deoxyribonucleic acid) from AURORA 1 baseline. [Up to 37 months]
12. Change Health Related Quality of Life Assessments (HRQoL) Short Form Health Survey (SF-36) [Months 18,24,30,36]
13. Healthcare Resource Utilization (HRU) [Months 12, 15, 18, 21, 24, 27, 30, 33, 36]
