The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Proteinuria Based on 24-hour UPCR at week 12
Time frame: Baseline and week 12
Change From Baseline in Proteinuria Based on Spot UPCR at Week 12 and week 26
Time frame: Baseline, Week 12 and Week 26
Change From Baseline in Serum Albumin at Week 12 and week 26
Time frame: Baseline, week 12 and Week 26
Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 12 and week 26
Time frame: Baseline, week 12 and week 26
Change From Baseline in Peripheral CD19+ B Cell Count at Week 4, Week 8, Week 12 and Week 26
Time frame: Baseline, Weeks 4, 8, 12 and 26
Change From Baseline biomarker level at Week 12 and 26
Time frame: Baseline and Weeks 12 and 26
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Research Site
Loma Linda, California, United States
RECRUITINGResearch Site
San Diego, California, United States
RECRUITINGResearch Site
Minneapolis, Minnesota, United States
RECRUITINGResearch Site
Rochester, Minnesota, United States
RECRUITINGResearch Site
Houston, Texas, United States
RECRUITINGResearch Site
Buenos Aires, Argentina
RECRUITINGResearch Site
CABA, Argentina
RECRUITINGResearch Site
Ciudad de Buenos Aires, Argentina
RECRUITINGResearch Site
La Plata, Argentina
NOT_YET_RECRUITINGResearch Site
Rosario, Argentina
RECRUITING...and 30 more locations