Effectiveness and Safety of Avacopan as Add-on to Standard of Care (SOC) Versus SOC Alone in ANCA-associated Vasculitis (LIBRA) (20240051)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000985
• Study ID:
  1000000985
• Official title and acronym:
  Effectiveness and Safety of Avacopan as Add-on to Standard of Care (SOC) Versus SOC Alone in ANCA-associated Vasculitis (LIBRA) (20240051)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  LIBRA is a retrospective, observational comparative effectiveness study designed to assess the real-world effectiveness and safety of avacopan as an add-on to standard of care (SOC) versus SOC alone among adults with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). The study uses longitudinal secondary data from US-based closed claims sources, including Optum Market Clarity and Komodo Healthcare Map, and applies a sequential nested trial framework to emulate treatment comparisons in routine clinical practice. The primary objectives are to compare time to first relapse, major adverse kidney events (MAKE) within 12 months, and the proportion of patients achieving a 30-day average prednisone-equivalent daily dose (PEDD) less than or equal to 7.5 mg at prespecified follow-up timepoints. Secondary objectives include glucocorticoid-related complications, relapse incidence by 12 months, individual MAKE components, hepatotoxicity/drug-induced liver injury, and serious hypersensitivity reactions. For hepatotoxicity/drug-induced liver injury and serious hypersensitivity reactions (endpoints with an anticipated low number of events), analyses will be descriptive only; cumulative risk will be estimated by treatment arm, and no between-arm comparative analysis will be conducted. Primary and secondary analyses were prespecified before conduct of the comparative analyses. To support transparency and reduce the potential for bias, the study used a staged analytic process with predefined checkpoints so that any design refinements or protocol modifications were made before the comparative analyses were conducted and were not informed by the comparative analysis results. Analyses are conducted separately in each database using a common prespecified framework and then combined using meta-analytic methods.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned:10/02/2026

Actual:10/02/2026

Study start date

Planned:10/02/2026

Actual:10/02/2026

Data analysis start date

Planned:17/03/2026

Actual:13/04/2026

Date of final study report

Planned:30/12/2027

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable