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Ligelizumab

Clinical trials of Ligelizumab are studying people with food allergy to see how safe and tolerable the treatment is over time. The trial data focus on long-term safety, including unwanted medical events, in a large group of participants. This article summarizes what was studied, who took part, and the main trial endpoint.

Table of Contents

Trial overview

The available trial data describe a long-term extension study of Ligelizumab in people with food allergy.[1] This means the study followed participants for a longer time to learn more about safety and tolerability.[1]

Who participated

The study population was people with food allergy.[1] The trial data do not give more detailed entry rules in the source provided, so the main target group we can confirm is participants with this condition.[1]

What was studied

The trial was designed to evaluate the long-term safety and tolerability of Ligelizumab in participants with food allergy.[1] In simple terms, the researchers wanted to see how well people handled the study treatment over time and whether any medical problems appeared during treatment.[1]

The intervention list in the source includes Ligelizumab listed as QGE031 in the study materials.[1] The source also lists placebo and rescue or support medicines such as epinephrine and salbutamol, but it does not explain how each was used in the study design.[1]

Main outcome measured

The primary outcome was the overall incidence and exposure-adjusted occurrence rates of treatment-emergent adverse events and serious adverse events.[1] This means the study counted medical problems that started during treatment and also adjusted the results for how long people stayed in the study.[1]

Adverse events are unwanted medical problems, and serious adverse events are the more severe ones.[1] The trial focused on these safety measures rather than on symptom relief or cure.[1]

Study design and phase

This was an interventional trial, which means the researchers gave a study treatment and then measured what happened.[1] The trial was in Phase 3, which is a later stage of clinical research with a larger number of participants.[1]

The study was also a long-term extension, so it appears to have continued observation after earlier research in the same program.[1] The source does not provide the earlier trial details, so only the extension study can be described here.[1]

Trial status and size

The trial status is listed as Completed.[1] The enrollment was 550 participants, showing that this was a fairly large food allergy study.[1]

Because the source data are limited to one trial record, the article cannot describe results beyond the stated safety objective and endpoint.[1]

Trial ID Phase Condition studied Status Enrollment
2022-502366-25-00 Phase 3 Food allergy Completed 550

FAQ

  • What is Ligelizumab being studied for in the trial data? The trial data show Ligelizumab being studied in people with food allergy. The main goal is to check long-term safety and tolerability.
  • Who can take part in these Ligelizumab trials? The available trial data focus on participants with food allergy. The study is designed for people who already have this condition.
  • What phase is the Ligelizumab food allergy trial? The trial is a Phase 3 study. Phase 3 trials usually test a treatment in a larger group of people.
  • What did the trial measure? The main outcome was the overall number of treatment-emergent adverse events and serious adverse events. These are medical problems that start or appear during treatment, including serious ones.
  • Was the Ligelizumab trial completed? Yes, the trial data show that this study was completed. It included 550 participants.

Ongoing Clinical Trials on Ligelizumab

  • Study on Long-Term Safety of Ligelizumab for Patients with Food Allergies

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Spain

Glossary

  • Food allergy: A condition where the body reacts to certain foods in a harmful way.
  • Phase 3: A later stage of clinical research that usually studies a treatment in a larger group of people.
  • Interventional study: A trial where researchers give a treatment or intervention and then measure what happens.
  • Long-term extension study: A study that follows people for a longer time after an earlier trial to learn more about safety or results over time.
  • Safety: How well a treatment is tolerated and whether it causes medical problems.
  • Tolerability: How easy a treatment is for people to take and how well they handle it.
  • Treatment-emergent adverse events: Medical problems that begin or get worse after treatment starts.
  • Serious adverse events: Severe medical problems that can be dangerous, need hospital care, or cause major harm.
  • Exposure-adjusted occurrence rate: A way to compare how often events happen while also considering how long people were in the study.
  • Enrollment: The number of people who joined a study.

References

  1. https://clinicaltrials.gov/study/2022-502366-25-00