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

Conditions

• Lupus Nephritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study 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.

Key Dates

Start date

Aug 10, 2022

Status verified

May 2026

Primary completion

Mar 19, 2026

Completion

Sep 28, 2028

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Iptacopan + standard of care (part 1)
  Iptacopan + standard of care
• Placebo Comparator: Placebo matching iptacopan + standard of care (part 1)
  Placebo matching iptacopan standard of care
• Active Comparator: Iptacopan + standard of care (part 2)
  Iptacopan + standard of care
• Active Comparator: Iptacopan + placebo (part 2)
  Iptacopan + placebo standard of care
• Active Comparator: Placebo matching iptacopan + standard of care (part 2)
  Placebo matching iptacopan + standard of care

Primary Outcome Measure

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

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (26)

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