ArticleKidney international reports2022
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG
Article in Kidney international reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03719443 (A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy Subjects), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy Subjects
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Efficacy and safety of sibeprenlimab in IgA nephropathy: a systematic review and meta-analysis of randomized controlled trials.BMC nephrology · 2026Pooled it
- A first-in-human, randomized study of the safety, pharmacokinetics and pharmacodynamics of povetacicept, an enhanced dual BAFF/APRIL antagonist, in healthy adults.Clinical and translational science · 2024Trial
- A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy.The New England journal of medicine · 2024Trial
- Targeting the B-Cell Activating Factor and a Proliferation-Inducing Ligand Pathway in IgAN: From Disease Pathogenesis to Clinical Trial Evidence.Kidney international reports · 2026Review
- Beyond affinity: AI-supported developability assessment and multi-objective optimization in antibody development.Antibody therapeutics · 2026Review
- Efficacy and safety of sibeprenlimab in IgA nephropathy: interim analysis of the China cohort in the phase 3 VISIONARY trial.Clinical kidney journal · 2026Article
- Structure and function of therapeutic antibodies approved by the US FDA in 2025.Antibody therapeutics · 2026Review
- A year in pharmacology: new drugs approved by the US food and drug administration in 2025.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Sibeprenlimab: First Approval.Drugs · 2026Review
- The evolving field of nephrology: what comes next? A report from the European Renal Association Scientific Advisory Board.Clinical kidney journal · 2026Review
- Review
- Evaluating Sibeprenlimab in IgA Nephropathy - Rationale and Baseline Data from the VISIONARY Trial.Kidney international reports · 2025Article
- IgA Nephropathy: An Overview of the Clinical Trials.Kidney medicine · 2025Review
- Advancements in understanding the role of intestinal dysbacteriosis mediated mucosal immunity in IgA nephropathy.BMC nephrology · 2024Review
- Drugs in Development to Treat IgA Nephropathy.Drugs · 2024Review
- Insights on NefeconDrug design, development and therapy · 2024Review
- IgA Nephropathy: Beyond the Half-Century.Medicina (Kaunas, Lithuania) · 2023Review
- A PRoliferation-Inducing Ligand (APRIL) in the Pathogenesis of Immunoglobulin A Nephropathy: A Review of the Evidence.Journal of clinical medicine · 2023Review
- IgA Nephropathy: Current Treatment and New Insights.Antibodies (Basel, Switzerland) · 2023Review
- Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria.Kidney international reports · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: VIS649 (sibeprenlimab), a humanized IgG Methods: Participants were randomized to VIS649 (sequential i.v. dosing cohorts: 0.5, 2.0, 6.0, 12.0 mg/kg) or placebo; a further cohort received VIS649 6.0 mg/kg or placebo followed by a tetanus/diphtheria vaccine challenge. Results: A total of 51 participants were randomized, dosed, and analyzed for safety (7 for each VIS649 dose; 8 for placebo; 10 for VIS649 + vaccine; 5 for placebo + vaccine). There were no serious adverse events (AEs) or AEs leading to study discontinuation. VIS649 had nonlinear PK: half-life increased with dose and drug exposure increased in a greater than dose-proportional manner. Serum APRIL, IgA, galactose-deficient (Gd) IgA Conclusion: VIS649 was safe, well tolerated, and reversibly suppressed APRIL and various immunoglobulins, without loss of antigen-specific vaccination response. Further clinical development of VIS649 for IgAN is warranted. Trial registration: ClinicalTrials.gov: NCT03719443.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.