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

  • STATUS
    Recruiting
  • End date
    Mar 13, 2028
  • participants needed
    240
  • sponsor
    Novartis Pharmaceuticals
Updated on 21 October 2022
corticosteroids
treatment regimen
hydroxychloroquine
nephritis
antimalarial agents

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.

Details
Condition Lupus Nephritis
Treatment Iptacopan (part 1), Iptacopan (part 2), Placebo + standard of care, Iptacopan + placebo
Clinical Study IdentifierNCT05268289
SponsorNovartis Pharmaceuticals
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
screening 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 10 mg/day prednisone (or equivalent) in the
previous 4 weeks and more than an average of 20 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
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