Abstract: INFO34
A Phase 2 Study Evaluating the Efficacy and Safety of Ravulizumab 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 Diseases, Boston, Massachusetts, United States
- Rice, Kara, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
- Spoerri, Nicole, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
- Najafian, Nader, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
Description
IgAN and LN are characterized by deposition of immune complexes, leading to activation of complement and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT04564339) will evaluate the efficacy and safety of ravulizumab, a humanized monoclonal antibody that inhibits complement C5, in adults with IgAN or LN and is open for enrollment. 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 2:1 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 after Week 26, potential use of rescue therapy in LN, interim pharmacokinetic/pharmacodynamic analysis, and an observational follow-up period allowing data collection after study drug discontinuation.
Figure. Study schematic for the LN and IgAN cohort
Funding
- Alexion, AstraZeneca Rare Disease
Abstract: INFO34
A Phase 2 Study Evaluating the Efficacy and Safety of Ravulizumab 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 Diseases, Boston, Massachusetts, United States
- Rice, Kara, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
- Spoerri, Nicole, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
- Najafian, Nader, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
Description
IgAN and LN are characterized by deposition of immune complexes, leading to activation of complement and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT04564339) will evaluate the efficacy and safety of ravulizumab, a humanized monoclonal antibody that inhibits complement C5, in adults with IgAN or LN and is open for enrollment. 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 2:1 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 after Week 26, potential use of rescue therapy in LN, interim pharmacokinetic/pharmacodynamic analysis, and an observational follow-up period allowing data collection after study drug discontinuation.
Figure. Study schematic for the LN and IgAN cohort
Abstract: INFO34
A Phase 2 Study Evaluating the Efficacy and Safety of Ravulizumab 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 Diseases, Boston, Massachusetts, United States
- Rice, Kara, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
- Spoerri, Nicole, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
- Najafian, Nader, Alexion, AstraZeneca Rare Diseases, Boston, Massachusetts, United States
Description
IgAN and LN are characterized by deposition of immune complexes, leading to activation of complement and inflammation. Despite treatment, many patients with IgAN or LN progress to kidney failure. This global, multicenter, phase 2 study (NCT04564339) will evaluate the efficacy and safety of ravulizumab, a humanized monoclonal antibody that inhibits complement C5, in adults with IgAN or LN and is open for enrollment. 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 2:1 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 after Week 26, potential use of rescue therapy in LN, interim pharmacokinetic/pharmacodynamic analysis, and an observational follow-up period allowing data collection after study drug discontinuation.
Figure. Study schematic for the LN and IgAN cohort