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NCT04984876 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
NCT04984876: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04984876 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 211 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04984876, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
Study Summary
This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SC q4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of Immunoglobulin E (IgE) mediated peanut allergy.
Primary Outcome
Responder rate was defined as the percentage of participants tolerating a single dose of \>= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at t
Interventions
- DRUG Placebo
- DRUG ligelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2023-11-27 |
| Phase | Phase 3 |
Why NCT04984876 stopped before completion
NCT04984876 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04984876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04984876 about?
NCT04984876 is a clinical study titled "Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy". This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SC q4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of I...
What is the current status of trial NCT04984876?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2021-12-07. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT04984876?
The interventions under investigation include: Placebo (DRUG), ligelizumab (DRUG).
Who is sponsoring clinical trial NCT04984876?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04984876's enrollment target sits among peer trials
211 1337th of 2000 higher than 663 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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