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Vib1116

Clinical trials are investigating Vib1116 in people with Sjögren’s syndrome. This article explains what the study aimed to evaluate, including safety and effectiveness, and which patients were included, such as those with systemic disease activity or ongoing symptoms.

Table of contents

Trial overview

The main clinical trial for Vib1116 was a Phase 2 study in people with Sjögren’s syndrome.[1] It was an interventional study, which means participants received a study treatment or a control treatment so researchers could compare outcomes.[1] The trial was completed and enrolled 312 participants.[1]

Who was studied

The study focused on participants with Sjögren’s syndrome.[1] The brief summary shows two groups of interest: people with moderate-to-severe systemic disease activity and people with an unsatisfactory symptom state.[1] In simple terms, this means the trial looked at people whose disease was affecting the body in a more serious way, or whose symptoms were still not well controlled.[1]

What the trial measured

The main outcomes were changes from baseline in two scores: the ESSDAI total score and the ESSPRI total score.[1] ESSDAI measures disease activity, meaning how active the illness is in the body.[1] ESSPRI measures patient-reported symptoms, meaning how patients themselves rate their symptoms.[1] The trial planned to compare these scores at Week XX, as listed in the source data.[1]

Trial phase and status

This study was in Phase 2.[1] Phase 2 trials usually look more closely at whether a treatment may help and continue to monitor safety.[1] The study status was Completed.[1]

Treatment groups

The intervention list shows Vib1116 given by subcutaneous use, which means under the skin.[1] The source also lists commercially available 0.9% saline solution intended for subcutaneous administration as a comparison treatment.[1] The trial data do not provide more detail on the group assignments in the source text, so the main point is that the study compared Vib1116 with a saline control in this research setting.[1]

What the results were designed to show

The study was designed to see whether Vib1116 could improve the body-wide features of Sjögren’s syndrome and the symptoms that patients feel in daily life.[1] By measuring both ESSDAI and ESSPRI, the researchers aimed to capture both clinical disease activity and the patient’s own experience of the illness.[1] This makes the trial important for understanding whether the treatment may help in more than one way for people with Sjögren’s syndrome.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06312020 Phase 2 Sjögren’s syndrome Completed 312

FAQ

  • What condition was studied in the Vib1116 trial? The trial studied Sjögren’s syndrome. It looked at people with either systemic disease activity or bothersome symptoms.
  • What was the main goal of the Vib1116 study? The study aimed to see whether Vib1116 could improve disease activity and patient-reported symptoms. It also looked at safety.
  • Who could take part in the trial? The trial included participants with moderate-to-severe systemic disease activity or an unsatisfactory symptom state. These were people with Sjögren’s syndrome.
  • What phase was the Vib1116 trial? This was a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to check safety.
  • What did the trial measure? It measured change in ESSDAI and ESSPRI scores over time. These are scores that show disease activity and how patients feel about their symptoms.

Ongoing Clinical Trials on Vib1116

  • Study on the Effects of HZN-1116 for Patients with Sjögren’s Syndrome

    Not recruiting

    2 1
    Investigated drugs:
    Austria Bulgaria France Germany Greece Hungary +5

Glossary

  • Sjögren’s syndrome: A long-term disease where the immune system affects the body, often causing symptoms and systemic problems.
  • Systemic disease activity: Signs that the disease is affecting the body beyond just one area. It can involve several organs or body systems.
  • Patient-reported symptoms: Symptoms that patients describe themselves, such as how they feel day to day.
  • Moderate-to-severe: A level of illness that is not mild and may cause more noticeable problems.
  • Unsatisfactory symptom state: A condition where symptoms are still troubling or not well controlled.
  • Phase 2: A stage of clinical research that helps show whether a treatment may work and continues to watch safety.
  • Interventional study: A trial where participants receive a study treatment or control so researchers can compare results.
  • ESSDAI: A score used to measure disease activity in Sjögren’s syndrome.
  • ESSPRI: A score used to measure how patients rate their symptoms in Sjögren’s syndrome.
  • Baseline: The starting point before treatment begins. Later results are compared with this.

References