Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Conditions

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis

Brief summary

Incidence of TEAEs and TESAEs., Changes from Baseline in safety assessments (vital sign measurements, physical examination, clinical laboratory tests, and ECG results).

Detailed description

Achieving disease remission at Week 26., Achieving sustained remission at Week 52., Achieving BVAS = 0 at [CCI], 26, and 52., Relapse after previously achieving disease remission at Week 26., Time to first relapse after having achieved disease remission at Week 26., Change from Baseline in Vasculitis Damage Index (VDI) at [CCI] 26, and 52., Time to first occurrence of BVAS = 0., Change from Baseline in BVAS at all timepoints., Change from Baseline in eGFR (mL/min per 1.73 m2) at [CCI] 26, and 52., Change from Baseline in proteinuria based on spot UPCR (mg/g) and % change from Baseline at [CCI] 26, and 52., Change from Baseline in proteinuria based on spot UACR (mg/g) and % change from Baseline at [CCI] 26, and 52., Hematuria change from Baseline (RBCs/HPF) and % change from Baseline at [CCI] 26, and 52.

Related papers

No related papers found yet.

Interventions

DRUGTarperprumig Placebo

DRUGTarperprumig

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of TEAEs and TESAEs., Changes from Baseline in safety assessments (vital sign measurements, physical examination, clinical laboratory tests, and ECG results).	—

Secondary

Measure	Time frame
Achieving disease remission at Week 26., Achieving sustained remission at Week 52., Achieving BVAS = 0 at [CCI], 26, and 52., Relapse after previously achieving disease remission at Week 26., Time to first relapse after having achieved disease remission at Week 26., Change from Baseline in Vasculitis Damage Index (VDI) at [CCI] 26, and 52., Time to first occurrence of BVAS = 0., Change from Baseline in BVAS at all timepoints., Change from Baseline in eGFR (mL/min per 1.73 m2) at [CCI] 26, and 52., Change from Baseline in proteinuria based on spot UPCR (mg/g) and % change from Baseline at [CCI] 26, and 52., Change from Baseline in proteinuria based on spot UACR (mg/g) and % change from Baseline at [CCI] 26, and 52., Hematuria change from Baseline (RBCs/HPF) and % change from Baseline at [CCI] 26, and 52.	—

Measure

Time frame

Achieving disease remission at Week 26., Achieving sustained remission at Week 52., Achieving BVAS = 0 at [CCI], 26, and 52., Relapse after previously achieving disease remission at Week 26., Time to first relapse after having achieved disease remission at Week 26., Change from Baseline in Vasculitis Damage Index (VDI) at [CCI] 26, and 52., Time to first occurrence of BVAS = 0., Change from Baseline in BVAS at all timepoints., Change from Baseline in eGFR (mL/min per 1.73 m2) at [CCI] 26, and 52., Change from Baseline in proteinuria based on spot UPCR (mg/g) and % change from Baseline at [CCI] 26, and 52., Change from Baseline in proteinuria based on spot UACR (mg/g) and % change from Baseline at [CCI] 26, and 52., Hematuria change from Baseline (RBCs/HPF) and % change from Baseline at [CCI] 26, and 52.

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Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed