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Long-term Ligelizumab for Food Allergy

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, 10 days before and 3 days after week 52, 10 days before and 3 days after week 104, 10 days before and 3 days after week 156

Awards & highlights

Study Summary

This trial looks at the long-term effects of a medication for food allergies.

Who is the study for?

This trial is for individuals who have completed a Phase III study of ligelizumab for food allergies. They must be willing to follow the study's schedule, avoid allergens, and participate in oral food challenges. People with severe allergic reactions during previous studies, uncontrolled asthma, or significant health issues that could affect safety are not eligible.Check my eligibility

What is being tested?

The trial is testing long-term effects of two doses of ligelizumab (120 mg and 240 mg) on people with food allergies. It aims to understand the ongoing safety and effectiveness after initial positive results from earlier trials.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any long-term adverse reactions related to ligelizumab since this extension study focuses on its continued safety and efficacy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 10 days before and 3 days after week 52, 10 days before and 3 days after week 104, 10 days before and 3 days after week 156

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 10 days before and 3 days after week 52, 10 days before and 3 days after week 104, 10 days before and 3 days after week 156

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 10 days before and 3 days after week 52, 10 days before and 3 days after week 104, 10 days before and 3 days after week 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of treatment-emergent AEs and SAEs

Secondary outcome measures

Number of participants tolerating a single dose of more than or equal to 600 mg of peanut protein without dose-limiting symptoms

Number of treatment emergent AEs and SAEs

Scores in the Food Allergy Independent Measure (FAIM) by age and responder

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Ligelizumab 240 mgExperimental Treatment1 Intervention

240 mg

Group II: Ligelizumab 120 mgExperimental Treatment1 Intervention

120 mg

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,859 Previous Clinical Trials

4,197,694 Total Patients Enrolled

1 Trials studying Food Allergy

20 Patients Enrolled for Food Allergy

Media Library

Ligelizumab 120 mg Clinical Trial Eligibility Overview. Trial Name: NCT05678959 — Phase 3

Food Allergy Research Study Groups: Ligelizumab 120 mg, Ligelizumab 240 mg

Food Allergy Clinical Trial 2023: Ligelizumab 120 mg Highlights & Side Effects. Trial Name: NCT05678959 — Phase 3

Ligelizumab 120 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05678959 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation open to those who exceed the age of 25?

"The age range for this trial is between 6 and 57 years old. There are 91 studies targeting minors, while 171 trials focus on elderly patients."

Answered by AI

Has the FDA authorized Ligelizumab 120 mg for public consumption?

"Our team has deemed the safety of Ligelizumab 120 mg a 3, as we have observed multiple rounds of data confirming its efficacy and general security."

Answered by AI

Is the research team currently recruiting participants for this experiment?

"Affirmative. Details hosted on clinicaltrials.gov indicate that this medical trial, which was initially published on April 27th 2023, is presently recruiting. 550 participants are needed for the study at 1 site of operation."

Answered by AI

How many participants are being tracked in this research endeavor?

"Yes, according to the information on clinicaltrials.gov this trial is currently accepting participants. First posted on April 27th 2023 and last modified on May 17th 2023, it requires 550 patients from 1 site for completion."

Answered by AI

Am I able to join this investigation?

"This medical research seeks to include 550 individuals between the age of 6 and 57 that suffer from food allergies. Crucially, participants must provide signed consent forms, have completed previous trials with ligelizumab in food allergy, agree to comply with study visits which includes receiving injections and taking part in oral challenge tests, and commit to avoiding all allergens (as specified by core studies) for the duration of this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long-term Extension Study of Ligelizumab in Food Allergy

2023. "Long-term Extension Study of Ligelizumab in Food Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05678959.

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