The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Participants will receive placebo.
Participants will receive tarperprumig.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline through Week 70
Number of Participants Achieving Disease Remission at Week 26
Time frame: Week 26
Number of Participants Achieving Sustained Remission at Week 52
Time frame: Week 52
Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0
Time frame: Baseline through Week 52
Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26
Time frame: Week 26 through Week 70
Time to First Relapse After Having Achieved Disease Remission at Week 26
Time frame: Week 26 through Week 70
Change from Baseline in Vasculitis Damage Index
Time frame: Baseline, Weeks 26, and 52
Time to First Occurrence of BVAS of 0
Time frame: Baseline through Week 52
Change from Baseline in BVAS
Time frame: Baseline, Weeks 26, and 52
Change from Baseline in Estimated Glomerular Filtration Rate
Time frame: Baseline, Weeks 26, and 52
Change from Baseline in Proteinuria Based on Spot Urine Protein-Creatinine Ratio
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Research Site
Ciudad de Buenos Aires, Argentina
RECRUITINGResearch Site
Ciudad de Buenos Aires, Argentina
RECRUITINGResearch Site
La Plata, Argentina
RECRUITINGResearch Site
Rosario, Argentina
RECRUITINGResearch Site
San Juan Bautista, Argentina
RECRUITINGResearch Site
Santa Fe, Argentina
WITHDRAWNResearch Site
Clayton, Australia
RECRUITINGResearch Site
Heidelberg, Australia
RECRUITINGResearch Site
Nedlands, Australia
RECRUITINGResearch Site
Wollongong, Australia
RECRUITING...and 68 more locations
Time frame: Baseline, Weeks 26, and 52
Change from Baseline in Proteinuria Based on Spot Urine Albumin-Creatinine Ratio
Time frame: Baseline, Weeks 26, and 52
Change from Baseline in Hematuria
Time frame: Baseline, Weeks 26, and 52