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Vixarelimab

Clinical trials are studying Vixarelimab in people with idiopathic pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and moderate to severe ulcerative colitis. These studies are looking at whether the treatment can improve outcomes and how safe it is. They also measure specific health results such as lung function and clinical remission.

Table of contents

Overview of the studies

Two interventional studies of Vixarelimab are listed, and both are marked as completed.[1][2] Both studies are Phase 2 trials, which means they were designed to look for early signs of benefit while also checking safety.[1][2]

The trials focused on two different disease areas: lung disease and inflammatory bowel disease.[1][2] One study included people with idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease, and the other included people with moderate to severe ulcerative colitis.[1][2]

Trial in lung disease

The first study, 2022-502828-42-00, compared Vixarelimab with placebo in patients with idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease.[1] It was a Phase 2 study with 330 people enrolled.[1]

The brief summary says the study was designed to evaluate the efficacy of Vixarelimab compared with placebo on lung function for each cohort.[1] In simple words, the researchers wanted to see whether the study treatment could help people breathe better or keep lung function from getting worse.[1]

Trial in ulcerative colitis

The second study, 2023-506655-19-00, evaluated the efficacy, safety, and pharmacokinetics of Vixarelimab in participants with moderate to severe ulcerative colitis.[2] It was also a Phase 2 study and enrolled 260 participants.[2]

This study compared Vixarelimab with placebo for the induction of clinical remission at Week 12.[2] The trial also included several other treatments in the intervention list, but the trial objective in the source data specifically focused on Vixarelimab versus placebo.[2]

Key endpoints and what they mean

In the lung study, the main endpoint was the absolute change from baseline to Week 52 in FVC.[1] FVC stands for forced vital capacity, which is a test that measures how much air a person can breathe out after taking a deep breath.[1]

In the ulcerative colitis study, the main endpoint was clinical remission at Week 12.[2] Clinical remission was defined by a modified Mayo Score of 2 or less, with stool frequency 1 or less, rectal bleeding 0, and endoscopy 1 or less.[2]

The term pharmacokinetics was also part of the ulcerative colitis study.[2] This means the researchers were also looking at how the body handles the treatment over time.[2]

Who the trials were for

These studies were aimed at adults with specific diagnosed conditions, not at the general population.[1][2] The lung study was for patients with idiopathic pulmonary fibrosis or systemic sclerosis-associated interstitial lung disease, while the other study was for participants with moderate to severe ulcerative colitis.[1][2]

  • People with idiopathic pulmonary fibrosis: this group had a lung disease marked by scarring in the lungs.[1]
  • People with systemic sclerosis-associated interstitial lung disease: this group had lung involvement linked to systemic sclerosis.[1]
  • People with moderate to severe ulcerative colitis: this group had a more active form of inflammatory bowel disease, which can cause frequent bowel symptoms and inflammation.[2]

What the completed status means

Both studies are listed as completed, which means the planned study work has finished and the results can be analyzed.[1][2] The source data provided here does not include the final results, so it only tells us what the trials were designed to measure.[1][2]

Trial ID Phase Condition studied Status Enrollment
2022-502828-42-00 Phase 2 Idiopathic pulmonary fibrosis; systemic sclerosis-associated interstitial lung disease Completed 330
2023-506655-19-00 Phase 2 Moderate to severe ulcerative colitis Completed 260

FAQ

  • What conditions are being studied with Vixarelimab? The trials are studying Vixarelimab in idiopathic pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and moderate to severe ulcerative colitis.
  • What phase are the Vixarelimab trials? Both trials provided are Phase 2 studies. Phase 2 trials usually look more closely at whether a treatment works and continue to check safety.
  • Who can take part in these trials? People with the listed conditions may be eligible, depending on the trial. One study includes patients with lung fibrosis conditions, and the other includes participants with moderate to severe ulcerative colitis.
  • What are the trials trying to measure? One trial measures change in lung function by week 52 using FVC, which is a test of how much air a person can breathe out. The other trial measures clinical remission at week 12 in ulcerative colitis.
  • Are these Vixarelimab studies still ongoing? No. Both trials in the data are marked as completed.

Sperimentazioni cliniche in corso su Vixarelimab

  • Studio sull’efficacia e la sicurezza di vixarelimab in pazienti con colite ulcerosa da moderata a grave

    Arruolamento concluso

    1 1
    Farmaci in studio:
    Belgio Cechia Francia Germania Grecia Italia +1

  • Studio sull’efficacia e sicurezza di Vixarelimab in pazienti con Fibrosi Polmonare Idiopatica e Malattia Polmonare Interstiziale associata a Sclerosi Sistemica

    Arruolamento concluso

    1
    Malattie in studio:
    Farmaci in studio:
    Belgio Francia Germania Grecia Ungheria Italia +2

Glossario

  • Idiopathic pulmonary fibrosis: A lung disease that causes scarring in the lungs. 'Idiopathic' means the cause is not known.
  • Systemic sclerosis-associated interstitial lung disease: A lung condition that happens in people with systemic sclerosis and affects the tissue around the air sacs in the lungs.
  • Ulcerative colitis: A long-term disease that causes inflammation and sores in the colon and rectum.
  • Phase 2: A stage of clinical research that looks at early signs of how well a treatment works and continues to check safety.
  • Interventional study: A trial where researchers give a treatment and compare results with another group or placebo.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Efficacy: How well a treatment works in a study.
  • Safety: How well a treatment is tolerated and whether it causes problems during the study.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • Forced vital capacity (FVC): A lung function test that measures how much air a person can force out after taking a deep breath.
  • Clinical remission: A state where signs and symptoms of a disease are very low or absent.
  • Modified Mayo Score (mMS): A scoring system used in ulcerative colitis to measure disease activity, including stool frequency, rectal bleeding, and endoscopy findings.

Riferimenti

  1. https://clinicaltrials.gov/study/2022-502828-42-00
  2. https://clinicaltrials.gov/study/2023-506655-19-00