An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +/- V
Novartis Pharmaceuticals
Summary
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
Description
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis. Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS. eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Sup…
Interventions
- DrugIptacopan (part 1)
Taken for 52 Weeks
- DrugIptacopan (part 2)
Taken for 52 Weeks
- DrugPlacebo + standard of care
Taken for 52 Weeks
- DrugIptacopan + placebo
Taken for 52 Weeks
Locations (103)
- AKDHC Medical Research ServicesLLCPhoenix, Arizona
- Kaiser Permanente FontanaFontana, California
- Univ Calif IrvineIrvine, California
- Ronald Reagan UCLA Medical CenterLos Angeles, California
- Loma Linda UniversitySan Bernardino, California
- Olive View UCLA Medical CenterSylmar, California