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Monoclonal Antibodies

Ligelizumab for Peanut Allergy

Phase 3
Waitlist Available
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 baseline, week 16, 56 and 68
Awards & highlights

Study Summary

This trial will test if an injection of ligelizumab can help people with peanut allergies. The trial will last 52 weeks, and participants will be randomly assigned to receive either ligelizumab or a placebo. The trial will measure the safety and efficacy of two different doses of ligelizumab.

Who is the study for?
This trial is for individuals aged 6-55 with a medically confirmed diagnosis of IgE-mediated peanut allergy. They must weigh at least 20 kg, have positive tests for peanut-specific antibodies and skin reactions to peanuts, and experience symptoms from ≤100 mg of peanut protein. It's not for those with uncontrolled asthma or recent severe allergic events.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Ligelizumab (240 mg and 120 mg) given as an injection every four weeks compared to a placebo in reducing allergic reactions to peanuts over a period of one year.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical drug-related reactions such as pain at the injection site, fatigue, headaches, or allergic responses. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 16, 56 and 68
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16, 56 and 68 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who can tolerate a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Secondary outcome measures
Change from baseline in SPT mean wheal diameters at Week 16, Week 56 and Week 68
Change from baseline in peanut-specific IgE at Week 12, Week 16 and Week 52
Change from baseline in peanut-specific IgG4 at Week 12, Week 16 and 52
+8 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: ligelizumab 240 mgExperimental Treatment1 Intervention
ligelizumab 240 mg subcutaneous injection for 52 weeks
Group II: ligelizumab 120 mgExperimental Treatment1 Intervention
ligelizumab 120 mg subcutaneous injection for 52 weeks
Group III: Placebo 8 weeks and ligelizumab 240 mgExperimental Treatment2 Interventions
Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks
Group IV: Placebo 8 weeks and ligelizumab 120 mgExperimental Treatment2 Interventions
Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks
Group V: Placebo 16 weeks and ligelizumab 120 mg/240 mgExperimental Treatment2 Interventions
Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,142 Total Patients Enrolled

Media Library

ligelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04984876 — Phase 3
Peanut Allergy Research Study Groups: Placebo 16 weeks and ligelizumab 120 mg/240 mg, Placebo 8 weeks and ligelizumab 240 mg, ligelizumab 240 mg, ligelizumab 120 mg, Placebo 8 weeks and ligelizumab 120 mg
Peanut Allergy Clinical Trial 2023: ligelizumab Highlights & Side Effects. Trial Name: NCT04984876 — Phase 3
ligelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984876 — Phase 3
Peanut Allergy Patient Testimony for trial: Trial Name: NCT04984876 — Phase 3

Frequently Asked Questions

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

How many volunteers can join this research project?

"That is correct, the online information does show that the trial is still open and recruiting patients. The listing was created on December 7th, 2021 and was updated November 2nd, 2022. There are 486 total spots open for participants across 37 different locations."

Answered by AI

Who do the researchers hope to enroll in this clinical trial?

"486 patients that fit the following profile are required for this study: Ages 6-55, peanut allergies, able to attend Screening Visit 2, Part 1 and Part 2 DBPCFC, weighs at least 20 kg, male or female, positive peanut-specific immunoglobulin E (peanut sIgE), ≥ 0.35 kUA/L at Screening visit 1 (Screening 1), and positive skin prick test (SPT) for peanut allergen at Screening 1 defined as an average diameter (Longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to saline"

Answered by AI

What is the latest news on ligelizumab's FDA status?

"There is both efficacy and safety data available for ligelizumab, which our team has rated a 3 on our scale."

Answered by AI

Where are patients able to participate in this clinical trial?

"There are presently 37 sites enrolling patients for this clinical trial, with centres located in Saint Petersburg, Hamilton and Dallas, amongst others. To minimize travel requirements, you should select the enrolment site closest to your location."

Answered by AI

Can more people join this clinical trial?

"Per the clinicaltrials.gov website, this study is still looking for individuals to participate. The listing was created on December 7th, 2021 and was last updated on November 2nd, 2022."

Answered by AI

Is the age limit for this trial over 40 years old?

"The age range that this study is recruiting people for is between 6 and 55 years old."

Answered by AI

What are some other ways that ligelizumab has been studied?

"ligelizumab was first researched in 2021 by Novartis at their Investigative Site. To date, there have been 18244 completed studies. There are currently 2 live studies, with a majority of the trials taking place in Saint Petersburg, Florida."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To try and make a difference for someone to have a healthier life and.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
2021. "Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984876.
~63 spots leftby Apr 2025
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