Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UC Irvine UCLA
Dates
study started
completion around
Principal Investigator
by Yongen Chang (uci)Lama Abdelnour (ucla)Phuong-Chi Pham (ucla)
Headshot of Lama Abdelnour
Lama Abdelnour

Description

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.

Official Title

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

Details

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.

Keywords

Lupus Nephritis, LNP023, Iptacopan, proteinuria, Urine Protein-to-Creatinine Ratio, complete renal response, estimated glomerular filtration rate, renal flares, Systemic Lupus Erythematosus, Nephritis, Iptacopan (part 1), Iptacopan (part 2)

Eligibility

You can join if…

Open to people ages 18-100

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.

You CAN'T join if...

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

Locations

  • Univ Calif Irvine accepting new patients
    Irvine California 92697 United States
  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Olive View UCLA Medical Center accepting new patients
    Sylmar California 91342 United States

Lead Scientists at University of California Health

  • Yongen Chang (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 10 research publications
  • Lama Abdelnour (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 13 research publications. Research interests: Glomerular Diseases · IgA Nephropathy · Lupus Nephritis · FSGS · Membranous Nephropathy · Minimal Change Disease · ANCA Glomerulonephritis
  • Phuong-Chi Pham (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 63 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT05268289
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated