ligelizumab for Peanut Allergy

Novartis Investigative Site, Jacksonville, FL
Peanut Allergyligelizumab - Drug
Eligibility
6 - 55
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Peanut Allergy

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Baseline, Week 16, 56 and 68

Week 12
Change from baseline in total and domain scores in the FAIM by age and responder (subject and/or caregiver)
Change from baseline in total and domain scores in the FAQLQ by age and responder (subject and/or caregiver)
Change from baseline in total and domain scores in the SF-36v2 by age and responder (subject and/or caregiver)
Week 12
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
Week 16
Change from baseline in SPT mean wheal diameters at Week 16, Week 56 and Week 68
Week 12
Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000 mg at Week 12
Proportion of participants who can tolerate a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Proportion of participants who can tolerate a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
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
Week 52
Change in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 52 compared to Week 12
Week 52
Proportion of participants who can tolerate a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 52

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5 Treatment Groups

ligelizumab 240 mg
1 of 5
Placebo 8 weeks and ligelizumab 120 mg
1 of 5
Placebo 8 weeks and ligelizumab 240 mg
1 of 5
Placebo 16 weeks and ligelizumab 120 mg/240 mg
1 of 5
ligelizumab 120 mg
1 of 5

Experimental Treatment

211 Total Participants · 5 Treatment Groups

Primary Treatment: ligelizumab · Has Placebo Group · Phase 3

ligelizumab 240 mg
Drug
Experimental Group · 1 Intervention: ligelizumab · Intervention Types: Drug
Placebo 8 weeks and ligelizumab 120 mgExperimental Group · 2 Interventions: ligelizumab, Placebo · Intervention Types: Drug, Drug
Placebo 8 weeks and ligelizumab 240 mgExperimental Group · 2 Interventions: ligelizumab, Placebo · Intervention Types: Drug, Drug
Placebo 16 weeks and ligelizumab 120 mg/240 mgExperimental Group · 2 Interventions: ligelizumab, Placebo · Intervention Types: Drug, Drug
ligelizumab 120 mg
Drug
Experimental Group · 1 Intervention: ligelizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 16, 56 and 68

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,771 Previous Clinical Trials
3,830,023 Total Patients Enrolled

Eligibility Criteria

Age 6 - 55 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a medical history of being allergic to peanuts or foods that contain peanuts.

Who else is applying?

What state do they live in?
Michigan100.0%
What site did they apply to?
Novartis Investigative Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "To try and make a difference for someone to have a healthier life and"
How many prior treatments have patients received?
0100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.