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

ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

240 Participants
are divided into 5 treatment groups
Group A: Iptacopan + standard of care (part 1)Active comparator 1 intervention
Group B: Placebo matching iptacopan + standard of care (part 1)Placebo comparator 1 intervention
Group C: Iptacopan + standard of care (part 2)Active comparator 1 intervention
Group D: Iptacopan + placebo (part 2)Active comparator 1 intervention
Group E: Placebo matching iptacopan + standard of care (part 2)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares

Part 1: To evaluate the proportion of patients achieving complete renal response with iptacopan treatment "A" plus standard of care, compared to treatment alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "B" plus standard of care, compared to treatment "D" alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "C" plus standard of care, compared to treatment "D" alone Complete Renal Response is defined as meeting the following criteria: estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2 or no less than 85% of baseline value, and 24h urine protein-to-creatinine ratio (UPCR) ≤ 0.5 g/g.

Time frame
Baseline and week 24

Secondary outcomes

1

Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares

Proportion of patients achieving complete renal response or partial renal response

Time frame
Baseline, week 24, week 52
2

Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24

Frequency of renal flares between weeks 24 and 52

Time frame
Baseline, week 24 week 52
3

Log-transformed ratio to baseline of 24h UPCR at week 24

Dose exposure response for reduction in proteinurea. (each 24h urine protein-to-creatinine ratio value will based on two 24 urine collections sampled within 10 days before the respective study visit)

Time frame
Baseline week 24
4

Change from baseline FACIT-Fatigue Score

Measure fatigue in patients

Time frame
Weeks 24 and 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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