A Phase 3 Study of Felzartamab in Adults with IgAN
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)
IRAS ID
1011844
Contact name
CTA Submissions
Contact email
Sponsor organisation
Biogen Idec Research Limited
Research summary
This study will be a phase 3, randomized, double-blind, placebo-controlled study of Felzartamab in adults with IgA Nephropathy (PREVAIL). The main objective to learn about the effect of felzartamab on proteinuria compared to placebo in adults with IgAN. Study Endpoint would be determined based on how much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will use the UPCR to measure the amount of protein in urine.
About 454 men and women who are at least 18 years of age can enroll in the study. Participants must have IgAN confirmed by a kidney biopsy. A biopsy is a small sample of kidney tissue that doctors examine to check for disease. Participants must also:
• Have proteinuria, meaning high levels of protein in their urine.
• Have kidneys that are still working well enough to filter blood.
A smaller group of participants with reduced kidney function will be enrolled in a separate part of the study. For a full list of requirements, please contact the study doctor.
This study will have 3 periods - Screening, Treatment and Follow up. After screening, participants will be randomized to receive either felzartamab or placebo. Both felzartamab and placebo will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle. The exact dose of the drugs will vary between participants. After the Treatment Period, participants will remain in the study for another 80 weeks for more testing and monitoring.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
25/SC/0153
Date of REC Opinion
16 Jun 2025
REC opinion
Further Information Favourable Opinion