Table of Contents

• Clinical trials overview
• IgA nephropathy studies
• Sjögren’s disease study
• Who the trials include
• What the trials measure
• Trial phases and status

Clinical trials overview

Clinical trials are research studies in people that test whether a treatment may help with a disease and whether it is safe enough to use in that setting.^[1][2][3] The trials in this data study Sibeprenlimab in people with IgA nephropathy and Sjögren’s disease.^[1][2][3] The studies include a completed phase 3 trial, an authorised phase 4 trial, and an authorised phase 2 trial.^[1][2][3]

IgA nephropathy studies

IgA nephropathy, also called IgAN, is the main condition studied in two of the trials.^[1][2] One study is the VISIONARY Trial, a phase 3 interventional trial with 530 participants that was completed.^[1] It compared Sibeprenlimab with placebo added to standard of care, which means the usual treatment people were already receiving.^[1]

The main goal of this phase 3 study was to compare the change in uPCR, or urine protein-to-creatinine ratio, after 9 months.^[1] uPCR is a urine test that helps show how much protein is leaking into the urine, which is important in kidney disease.^[1] The brief summary says the study looked at the relative change from baseline, meaning it compared results after treatment with the starting measurement.^[1]

The second IgAN study is a phase 4 trial with 596 participants that is authorised.^[2] This study focuses on long-term safety and tolerability of Sibeprenlimab in people with IgAN.^[2] The main safety measures include treatment-emergent adverse events, laboratory tests, vital signs, physical examinations, and injection site reactions.^[2]

Sjögren’s disease study

The third trial studies Sibeprenlimab in Sjögren’s disease, which is an autoimmune disease that can affect the body in many ways.^[3] This is a phase 2 interventional study with 80 participants and is authorised.^[3] The study compares Sibeprenlimab with placebo on top of background treatment, which means the treatment people were already taking continued in the study.^[3]

The main endpoint is the change from baseline in ESSDAI at 28 weeks.^[3] ESSDAI is a disease activity score used to show how active Sjögren’s disease is.^[3] A lower or improved score can suggest less disease activity, depending on how the trial is designed to read the results.^[3]

Who the trials include

The available trial data show that the studies are aimed at people with the condition being tested, such as IgA nephropathy or Sjögren’s disease.^[1][2][3] The records do not provide full eligibility rules, so details such as age limits or other health requirements are not listed here.^[1][2][3] In clinical research, eligibility rules are the criteria used to decide who can join a study.^[1][2][3]

• IgA nephropathy trials: people with IgAN were included in the phase 3 and phase 4 studies.^[1][2]

• Sjögren’s disease trial: people with Sjögren’s disease were included in the phase 2 study.^[3]

What the trials measure

Each trial has a primary outcome, which is the main result the researchers want to measure.^[1][2][3] In the phase 3 IgAN study, the primary outcome was the ratio of uPCR at 9 months compared with baseline, based on a 24-hour urine collection.^[1] This helps researchers see whether protein in the urine changed after treatment.^[1]

In the phase 4 IgAN study, the main outcome was safety and tolerability, measured through treatment-emergent adverse events and clinical checks such as lab tests and physical exams.^[2] In the Sjögren’s disease study, the main outcome was the change in ESSDAI at 28 weeks.^[3] These endpoints are the planned measurements used to judge the study results.^[2][3]

• uPCR: used to measure urine protein changes in IgA nephropathy.^[1]

• ESSDAI: used to measure disease activity in Sjögren’s disease.^[3]

• Safety and tolerability: used to track whether the treatment causes problems and how well people handle it over time.^[2]

Trial phases and status

The phase of a trial shows the stage of testing.^[1][2][3] Phase 2 studies are often smaller and help explore whether a treatment may work, while phase 3 studies are larger and compare treatment with placebo or standard care.^[1][3] Phase 4 studies look at longer-term use after earlier studies.^[2]

In this dataset, the phase 3 IgAN study is completed, while the phase 4 IgAN study and the phase 2 Sjögren’s disease study are authorised.^[1][2][3] The enrollment numbers are 530 for the phase 3 IgAN study, 596 for the phase 4 IgAN study, and 80 for the Sjögren’s disease study.^[1][2][3]