BCX9930 for the Treatment of C3G, IgAN, and PMN (RENEW)

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioCryst Pharmaceuticals

Criteria

Inclusion Criteria:

• Male or female, aged ≥ 18 years old

• Body weight ≥ 40 kg

• Primary diagnosis of C3G, IgAN, or PMN confirmed by central pathology review

• An eGFR ≥ 50 mL/min/1.73 m2 (or ≥ 30 mL/min/1.73 m2 after DMC recommendation)

• Receiving treatment with a stable, maximum recommended or maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 60 days prior to the Day 1 Visit

• Documentation of current vaccinations against Neisseria meningitidis and Streptococcus pneumoniae or willingness to start vaccination series

Exclusion Criteria:

• Known congenital deficiency of C1s, C1r, C1q, C2, or C4

• History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation

• Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition

• History of malignancy within 5 years prior to the screening visit

• Active serious bacterial, viral, or fungal infection or any other serious infection within 14 days of screening

• Treatment with any systemic immunosuppressive or immunomodulatory therapy within 90 days OR within 180 days for anti-CD20 antibody therapies (eg, rituximab) prior to the screening visit

• Treatment with renin inhibitors (eg, aliskiren) or sodium-glucose-cotransporter 2 (SGLT2) inhibitor within 60 days prior to Day 1