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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 trials are looking at how well it works, how safe it is, and other research measures such as lung function, remission, and drug handling in the body.

Table of Contents

Trial overview

Clinical trials of Vixarelimab in the source data are studying people with lung disease and ulcerative colitis.[1][2] Both studies are Phase 2 and both are marked as completed.[1][2]

Lung disease study

One completed trial studied Vixarelimab in patients with idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease.[1] This was an interventional study, which means participants received a study treatment or placebo so results could be compared.[1]

The study compared Vixarelimab with placebo in 330 participants.[1] Its brief purpose was to evaluate efficacy and safety for each cohort, meaning each patient group was studied separately.[1]

Ulcerative colitis study

Another completed Phase 2 trial studied Vixarelimab in participants with moderate to severe ulcerative colitis.[2] The study was also interventional and included 260 participants.[2]

This trial compared Vixarelimab with placebo and also listed several other medicines in the source data, showing that the study was set up to evaluate treatment options in this disease area.[2] The brief summary says the trial aimed to evaluate efficacy in the induction of clinical remission at Week 12.[2]

Trial design and participants

Both studies were designed for patients with a specific disease group, not for healthy volunteers.[1][2] In the lung trial, the target groups were people with fibrotic lung disease, which means scarring in the lungs.[1]

In the bowel trial, the target group was people with moderate to severe ulcerative colitis, which means the disease was active enough to need careful treatment study.[2] The source data do not give detailed inclusion or exclusion rules, so only the disease groups can be confirmed here.[1][2]

Outcomes measured

The main outcome in the lung disease trial was the absolute change from baseline to Week 52 in FVC, or forced vital capacity.[1] FVC is the amount of air a person can breathe out after taking a deep breath, so it helps show how well the lungs are working.[1]

The main outcome in the ulcerative colitis trial was clinical remission at Week 12.[2] In this study, remission was defined by the modified Mayo Score, with low scores showing less disease activity and less bleeding, fewer bowel symptoms, and less inflammation seen on endoscopy.[2]

The ulcerative colitis trial also included pharmacokinetics, which means how the body handles the study drug over time.[2] This helps researchers understand exposure to the treatment during the study.[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 in Vixarelimab trials? The trials in the source data study idiopathic pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and moderate to severe ulcerative colitis. These are serious long-term diseases that affect the lungs or the bowel.
  • What phase are the Vixarelimab trials? Both trials listed are Phase 2 studies. Phase 2 trials mainly look at early signs of benefit and continue to assess safety.
  • Who can take part in these trials? One trial enrolled patients with idiopathic pulmonary fibrosis or systemic sclerosis-associated interstitial lung disease. The other enrolled participants with moderate to severe ulcerative colitis.
  • What are the main outcomes being measured? In the lung disease trial, the main outcome is change in forced vital capacity, or FVC, which is a measure of how much air a person can breathe out. In the ulcerative colitis trial, the main outcome is clinical remission at Week 12.
  • Are these Vixarelimab studies still open? No. Both trials in the source data are marked as completed. That means the planned study period has ended.

Ongoing Clinical Trials on Vixarelimab

  • A study to evaluate the efficacy and safety of vixarelimab in patients with moderate to severe ulcerative colitis

    Not recruiting

    2 1 1
    Investigated drugs:
    Belgium Czechia France Germany Greece Italy +1

  • Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Greece Hungary Italy +2

Glossary

  • Phase 2: A mid-stage clinical trial. It is designed to learn more about whether a treatment may help and to continue checking safety.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare results.
  • Placebo: An inactive treatment that looks like the study drug. It helps researchers see whether the study drug works better than no active treatment.
  • 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 problem linked to systemic sclerosis, a disease that can cause hardening and scarring in the body.
  • Ulcerative colitis: A long-term disease that causes inflammation and sores in the large intestine and rectum.
  • Clinical remission: A period when signs and symptoms of a disease are very low or absent.
  • Modified Mayo Score: A scoring system used to measure how active ulcerative colitis is. Lower scores mean less disease activity.
  • Forced vital capacity (FVC): The amount of air a person can forcefully breathe out after taking the deepest breath possible. It helps show how well the lungs are working.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • Cohort: A group of participants in a study who share a condition or treatment plan.

References

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