Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

Purpose

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.

Condition

  • Lupus Nephritis

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts 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 Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study. First presentation or flare of lupus nephritis.

Exclusion Criteria

Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization. Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening. Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy. Participants being treated with systemic corticosteroids (>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease. Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment) Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Iptacopan + standard of care (part 1)
Iptacopan + standard of care
  • Drug: Iptacopan (part 1)
    Taken for 52 Weeks
    Other names:
    • LNP023
Placebo Comparator
Placebo matching iptacopan + standard of care (part 1)
Placebo matching iptacopan standard of care
  • Drug: Placebo + standard of care
    Taken for 52 Weeks
Active Comparator
Iptacopan + standard of care (part 2)
Iptacopan + standard of care
  • Drug: Iptacopan (part 2)
    Taken for 52 Weeks
    Other names:
    • LNP023
Active Comparator
Iptacopan + placebo (part 2)
Iptacopan + placebo standard of care
  • Drug: Iptacopan + placebo
    Taken for 52 Weeks
    Other names:
    • LNP023 and placebo
Active Comparator
Placebo matching iptacopan + standard of care (part 2)
Placebo matching iptacopan + standard of care
  • Drug: Placebo + standard of care
    Taken for 52 Weeks

Recruiting Locations

Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
Contact:
Rana Nikbakht Malvajerdi
RNikbakht@mednet.ucla.edu

University of Colorado Denver
Aurora, Colorado 80045
Contact:
Elizabeth Wagner
Elizabeth.C.Wagner@cuanschutz.edu

Royal Research Corp
Hollywood, Florida 33021
Contact:
Yaili Perez
+1 954 940 0208
yailip@royalresearchcorp.com

Mayo Clinic Jacksonville
Jacksonville, Florida 32224
Contact:
Tia Wilkes
+1 904 953 7648
Wilkes.Quantia@mayo.edu

Florida Kidney Physicians
Riverview, Florida 33578
Contact:
Myra Rodriguez
mrodriguez@panoramichealth.com

Florida Kidney Physicians
Riverview, Florida 33578
Contact:
Yvette Martinez
ymartinez@panoramichealth.com

Wichita Community Clcl Onco Program
Wichita, Kansas 67214
Contact:
Barb Johnson
+1 316 494 4912
Bjohnson@wngpa.com

Ochsner Health System
New Orleans, Louisiana 70121
Contact:
Gavin Skipper
+1 504 842 3930
gavin.skipper@ochsner.org

Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts 02115
Contact:
Valentina Castro
vcastro3@bwh.harvard.edu

Stony Brook Internists PC
East Setauket, New York 11733

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Sarah Cleveland
clevels@ccf.org

Temple University
Philadelphia, Pennsylvania 19140
Contact:
Julia Aruta
+1 215 707 8984
julia.aruta@temple.edu

Prolato Clinical Research Center
Houston, Texas 77054
Contact:
Dilshad Begum
+1 832 338 9118
dbegum@prolato.org

Virginia Commonwealth University
Richmond, Virginia 23298
Contact:
Keila Najera
+1 804 828 0180
Keila.Najera@vcuhealth.org

FDI Clinical Research
San Juan, Puerto Rico 00927
Contact:
Digmarie Rivera Franceschini
+1 787 722 1248
drivera@fdipr.com

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed 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.