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To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

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Abstract: INFO33

A Phase 2 Study Evaluating the Efficacy and Safety of ALXN2050, a Complement Factor D inhibitor, in Patients With IgA Nephropathy (IgAN) or Proliferative Lupus Nephritis (LN)

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

  • No subcategory defined

Authors

  • Garlo, Katherine, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
  • Rice, Kara, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
  • Najafian, Nader, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
Description

IgAN and LN are glomerular diseases characterized by immune complex deposition, complement system activation and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT05097989) will evaluate the efficacy and safety of ALXN2050, an oral, small molecule complement factor D inhibitor, in adults with IgAN or LN. Key study design elements and endpoints are shown in the Figure. Key inclusion criteria include biopsy-confirmed IgAN or LN, proteinuria, and specific vaccination requirements. Key exclusion criteria include eGFR <30 mL/min/1.73m2 and prior complement or biologic therapy. The primary endpoint is change in proteinuria assessed by 24-hour urine collection(s) from baseline to Week 26. The study design incorporates 3:1:3 randomization in favor of the study drug arm, continued administration of standard of care medications in all treatment groups, placebo crossover to treatment for IgAN, and potential use of rescue therapy for renal flare for LN.

Figure. Study schematic for the LN and IgAN cohorts

Funding

  • Alexion, AstraZeneca Rare Disease
Abstract: INFO33

A Phase 2 Study Evaluating the Efficacy and Safety of ALXN2050, a Complement Factor D inhibitor, in Patients With IgA Nephropathy (IgAN) or Proliferative Lupus Nephritis (LN)

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Garlo, Katherine, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
  • Rice, Kara, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
  • Najafian, Nader, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
Description

IgAN and LN are glomerular diseases characterized by immune complex deposition, complement system activation and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT05097989) will evaluate the efficacy and safety of ALXN2050, an oral, small molecule complement factor D inhibitor, in adults with IgAN or LN. Key study design elements and endpoints are shown in the Figure. Key inclusion criteria include biopsy-confirmed IgAN or LN, proteinuria, and specific vaccination requirements. Key exclusion criteria include eGFR <30 mL/min/1.73m2 and prior complement or biologic therapy. The primary endpoint is change in proteinuria assessed by 24-hour urine collection(s) from baseline to Week 26. The study design incorporates 3:1:3 randomization in favor of the study drug arm, continued administration of standard of care medications in all treatment groups, placebo crossover to treatment for IgAN, and potential use of rescue therapy for renal flare for LN.

Figure. Study schematic for the LN and IgAN cohorts

Abstract: INFO33

A Phase 2 Study Evaluating the Efficacy and Safety of ALXN2050, a Complement Factor D inhibitor, in Patients With IgA Nephropathy (IgAN) or Proliferative Lupus Nephritis (LN)

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Garlo, Katherine, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
  • Rice, Kara, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
  • Najafian, Nader, Alexion, AstraZeneca Rare Disease,, Boston, Massachusetts, United States
Description

IgAN and LN are glomerular diseases characterized by immune complex deposition, complement system activation and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT05097989) will evaluate the efficacy and safety of ALXN2050, an oral, small molecule complement factor D inhibitor, in adults with IgAN or LN. Key study design elements and endpoints are shown in the Figure. Key inclusion criteria include biopsy-confirmed IgAN or LN, proteinuria, and specific vaccination requirements. Key exclusion criteria include eGFR <30 mL/min/1.73m2 and prior complement or biologic therapy. The primary endpoint is change in proteinuria assessed by 24-hour urine collection(s) from baseline to Week 26. The study design incorporates 3:1:3 randomization in favor of the study drug arm, continued administration of standard of care medications in all treatment groups, placebo crossover to treatment for IgAN, and potential use of rescue therapy for renal flare for LN.

Figure. Study schematic for the LN and IgAN cohorts