Voclosporin in Adolescents With Lupus Nephritis
- Conditions
- Adolescent Lupus Nephritis
- Interventions
- Drug: Placebo Oral Capsule
- Registration Number
- NCT05288855
- Lead Sponsor
- Aurinia Pharmaceuticals Inc.
- Brief Summary
The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active lupus nephritis (LN).
- Detailed Description
This is a 24 week, dose escalation study of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids, consisting of 3 treatment periods, in which period 1 is double-blind, placebo controlled, and period 2 and period 3 are open-label, with increasing doses of voclosporin in a pediatric population.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
- Subjects with kidney biopsy confirmed active lupus nephritis.
-
Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening.
-
Current or medical history of:
- Congenital or acquired immunodeficiency.
- Clinically significant drug or alcohol abuse prior to screening.
- Malignant neoplasm.
- Lymphoproliferative disease or previous total lymphoid irradiation.
- Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
- Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
-
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
-
Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
-
Currently taking or known need for any of the following medications:
- Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo treatment group Placebo Oral Capsule 2 capsules BID of placebo Voclosporin treatment group 1 Voclosporin 2 capsules (15.8 mg) BID of voclosporin Voclosporin treatment group 3 Voclosporin 3 capsules (23.7 mg) BID of voclosporin Voclosporin treatment group 4 Voclosporin Maximum dose of 4 capsules (31.6 mg) BID of voclosporin.
- Primary Outcome Measures
Name Time Method Proportion of subjects with renal response Week 24 Renal response defined as UPCR ≤0.5 mg/mg, eGFR ≥60 mL/min/1.73 m2 or no decrease from baseline of \>20%, no rescue medication and no steroid use \>10 mg/day for ≥3 consecutive days or for ≥7 days in total between week 16 to 24
- Secondary Outcome Measures
Name Time Method Time to UPCR of ≤0.5 mg/mg. Baseline to Week 24 Time in days to reduction in UPCR to ≤ 0.5 mg/mg
Proportion of subjects with partial renal response Week 24 defined as ≥50% reduction from baseline in UPCR
Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group Baseline to Week 24 Treatment-emergent adverse events will be summarized by treatment group, System Organ Class, and preferred term
Time to 50% Reduction in UPCR Baseline to Week 24 Time in days to reduction from baseline UPCR of at least 50% Organ Class, and preferred term.
Trial Locations
- Locations (1)
UNC-Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States