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