Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
Visionary
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy (IgAN)
Brief Description
This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment (eg, angiotensin-converting enzyme inhibitors [ACEIs] and/or angiotensin receptor blockers [ARBs]). Furthermore, subjects who are on a stable dose of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy for IgAN, in addition to ACEIs and/or ARBs, may participate in the trial if treatment was initiated at least 3 months prior to
screening.
Trial Physician / Study Coordinator
Erika Perez
EmailSite Name
Pioneer Research Solutions, Inc.
10700 Stancliff Rd Houston, TX 77099
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Drug
Sibeprenlimab
Estimated enrollment
470
Estimated end date
2026
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
Visionary
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy (IgAN)
Brief Description
This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment (eg, angiotensin-converting enzyme inhibitors [ACEIs] and/or angiotensin receptor blockers [ARBs]). Furthermore, subjects who are on a stable dose of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy for IgAN, in addition to ACEIs and/or ARBs, may participate in the trial if treatment was initiated at least 3 months prior to
screening.
Trial is for people with
Immunoglobulin A Nephropathy
Study Goal
Sibeprenlimab is being developed for the treatment of immunoglobin A nephropathy (IgAN), a chronic disease affecting the kidneys which is characterized clinically by proteinuria, hematuria, and progressive decline of glomerular filtration rate and histologically by deposition of Immunoglobulin A (IgA) in the kidney. This phase 3 trial will assess the efficacy and safety of sibeprenlimab administered SC once every 4 weeks as an add-on to standard of care (SOC) treatment.
What is involved for the Patient?
Subjects will be evaluated throughout the trial for safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity assessments. The total trial duration for each subject will be approximately 121 weeks (assuming up to60 days [approximately 9 weeks] for screening, 26 doses administered once every4 weeks from Day 1 to Week 100, a follow-up visit in Week 104, and ending with an end-of-trial visit in Week 112).
About the drug or intervention
Sibeprenlimab (VIS649) is a humanized IgG2 monocolonal antibody directed against the functionally conserved receptor binding domain of APRIL, blocking binding to its receptors, TACI, and BCMA.