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.
- Peanut Allergy
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: Baseline, Week 16, 56 and 68
Trial Safety
Phase-Based Safety
Awards & Highlights
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 6 - 55 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Michigan | 100.0% |
What site did they apply to?
| Novartis Investigative Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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?
| 0 | 100.0% |
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
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
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
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
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
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
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