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Looking for participantsPhase2

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

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT05268289

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Iptacopan (part 1) (drug), Iptacopan (part 2) (drug), Placebo + standard of care (drug), Iptacopan + placebo (drug)
How long the study runs
Study runs about 73 months (dates as stated)
About the drug or intervention
Iptacopan (part 1) — drug: Taken for 52 Weeks · Iptacopan (part 2) — drug: Taken for 52 Weeks · Placebo + standard of care — drug: Taken for 52 Weeks · Iptacopan + placebo — drug: Taken for 52 Weeks
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 100 Years
Who
All
Number of participants
240
Started
2022-08-10
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for lupus nephritis
  • • Phase2 - 240 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 100 Years
  • • Diagnosed with lupus nephritis

Where?

  • • Cambridge - Novartis Investigative Site
  • • Leicester - Novartis Investigative Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 100 Years
  • Who can join: All genders

Biomarkers mentioned

Unequivocally positiveor a positiveeGFR

What the study is looking for

  • ✓Documentation of active kidney disease at the time of screening necessitating the commencement of therapy with...
  • ✓First presentation or flare of lupus nephritis.

Who cannot take part

  • ✗Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with...
  • ✗Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to...
  • ✗Participants being treated with systemic corticosteroids (\>5 mg/day prednisone or equivalent) for indications other...
  • ✗Other protocol-defined inclusion/exclusion criteria may apply
See the full 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 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

Where Is This Study? (2 UK sites)

Novartis Investigative Site

Cambridge CB2 0QQ, United Kingdom

ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Leicester LE5 4PW, United Kingdom

WITHDRAWN

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

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

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111
Data sourced from ClinicalTrials.gov · Last verified: 2026-09