TerminatedPhase 2

Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Stopped: Sponsor Decision.

United States100 participantsStarted 2022-01-14

Plain-language summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams \[mg\]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years. Safety will be monitored throughout the study.

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕. ≥ 50% interstitial fibrosis and tubular atrophy
✕. ≥ 50% glomerular sclerosis
✕. ≥ 50% active crescent formation
✕. Cyclophosphamide ≤ 6 months prior to Screening
✕. CNIs ≤ 1 months prior to Screening
✕. A cumulative dose of intravenous (IV) methylprednisolone \> 3 g
✕. Mycophenolate mofetil \> 2 g/day (or equivalent) for ≥ 8 consecutive weeks prior to Screening
✕. Prednisone or prednisone equivalent ≥ 0.5 mg/kg/day for ≥ 8 consecutive weeks prior to Screening

What they're measuring

Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26

Timeframe: Baseline, Week 26

Trial details

NCT IDNCT05097989

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-09

Results submitted2025-08-15

View on ClinicalTrials.gov More Lupus Nephritis trials