Last Update: May 30, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLNP023K12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study 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. 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.

Lupus Nephritis
Phase2
Recruiting
240
Aug 10, 2022
Mar 13, 2028
All
18 Years - (Adult, Older Adult)

Interventions

Drug

Iptacopan (part 1)

Taken for 52 Weeks
Drug

Iptacopan (part 2)

Taken for 52 Weeks
Drug

Iptacopan + placebo

Taken for 52 Weeks
Drug

Placebo + standard of care

Taken for 52 Weeks

Eligibility Criteria

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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