Trial · NCT04984876
Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
NCT04984876, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy. Trials, record NCT04984876. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04984876
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
- NCT number
- NCT04984876
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 211 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Allergy, Peanut
- Interventions
- ligelizumab, Placebo
- First posted
- 2021-08-02
- Last updated
- 2025-04-29
- Other registries' IDs
- eudract:2020-005339-56
- Results first posted
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Week 12 | 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 the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. |
| Secondary | Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of \>= 1000 mg (2044 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 the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. |
| Secondary | Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of 3000 mg (5044 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 the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. |
| Secondary | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Week 12 | Symptom severity occurring at any challenge dose of peanut protein up to and including 1000 mg during the DBPCFC conducted at Week 12 was categorized as 4 levels: None, Mild, Moderate, Severe. The CoFAR grading system was used to categorize the symptom severity as mild, moderate and severe. Symptom severity for participants who completed DBPCFC without any symptom were categorized as none. |
| Secondary | Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 After 4 Weeks of Treatment | Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of \>= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12 after 4 weeks of treatment (8 weeks of placebo + 4 weeks of ligelizumab treatment versus 12 weeks of placebo). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. |
| Secondary | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | Week 52 | Responder rate was defined as the percentage of participants tolerating the specified peanut protein doses (\>= 600 mg (1044 mg cumulative tolerated dose), \>= 1000 mg (2044 mg cumulative tolerated dose) or 3000 mg (5044 mg cumulative tolerated dose)) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 52. 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 the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. |
| Secondary | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Baseline, Week 12, Week 52 | Change from baseline in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 12 and Week 52. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. |
| Secondary | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Baseline, Week 12, Week 52 | Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE) |
| Secondary | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Baseline, Week 12, Week 52 | Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4) |
| Secondary | Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | Baseline, Week 16/Week 56 | The Skin Prick Test (SPT) is a widely used diagnostic tool for identifying allergen-specific IgE-mediated allergies. During the test, a small amount of allergen, in this case, peanut allergen, is introduced into the skin. The allergen interacts with specific IgE antibodies bound to cutaneous mast cells. This interaction can cause a reaction, resulting in a wheal and flare on the skin. The size of the wheal and flare, specifically the longest diameter and the midpoint orthogonal diameter, were evaluated at each site and the average size of the wheal and flare across all sites was summarized and reported. Considering the study termination, SPT originally scheduled at Week 56 was performed 4 weeks after Week 12 assessment in some patients. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Week 12 | Full Analysis Set (FAS). This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Week 12 | Full Analysis Set (FAS). This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Week 12 | Full Analysis Set (FAS). This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Week 12 | Full Analysis Set (FAS). This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 After 4 Weeks of Treatment | Week 12 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | Week 52 | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. Week 52 includes participants who actually reached Week 52 and who reached any week between Week 12 and Week 52 as the end of treatment visit due to study early termination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Baseline, Week 12, Week 52 | Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included. | mg | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Baseline, Week 12, Week 52 | Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included. | kilounits per liter (kU/L) | MEAN |
| SECONDARY | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Baseline, Week 12, Week 52 | Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included. | mg/L | MEAN |
| SECONDARY | Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | Baseline, Week 16/Week 56 | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. | undiluted peanut protein (mm) | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group191
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Ligelizumab 240 mg | 21 | Participants | ||
| Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Ligelizumab 120 mg | 8 | Participants | ||
| Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Placebo | 1 | Participants | ||
| Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Ligelizumab 240 mg | 14 | Participants | ||
| Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Ligelizumab 120 mg | 6 | Participants | ||
| Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Placebo | 1 | Participants | ||
| Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Ligelizumab 240 mg | 7 | Participants | ||
| Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Ligelizumab 120 mg | 5 | Participants | ||
| Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Placebo | 1 | Participants | ||
| Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Ligelizumab 240 mg | None | 5 | Participants |
1 to 10 of 191Source ClinicalTrials.gov
See all 191 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ligelizumab 240 mg | 47 | |
| Overall Study | STARTED | Ligelizumab 120 mg | 51 | |
| Overall Study | STARTED | Placebo 8 Weeks and Ligelizumab 240 mg | 46 | |
| Overall Study | STARTED | Placebo 8 Weeks and Ligelizumab 120 mg | 44 | |
| Overall Study | STARTED | Placebo 16 Weeks and Ligelizumab 240 mg | 11 | |
| Overall Study | STARTED | Placebo 16 Weeks and Ligelizumab 120 mg | 12 | |
| Overall Study | Randomized Analysis Set (RAS) | Ligelizumab 240 mg | 47 | |
| Overall Study | Randomized Analysis Set (RAS) | Ligelizumab 120 mg | 51 | |
| Overall Study | Randomized Analysis Set (RAS) | Placebo 8 Weeks and Ligelizumab 240 mg | 46 | |
| Overall Study | Randomized Analysis Set (RAS) | Placebo 8 Weeks and Ligelizumab 120 mg | 44 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Placebo Controlled Period (Up to Week 8) Ligelizumab 240 mg SCq4w | 0 | 47 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Controlled Period (Up to Week 8) Ligelizumab 120 mg SCq4w | 0 | 51 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Controlled Period (Up to Week 8): Placebo | 3 | 113 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Controlled Period (Up to Week 16) Ligelizumab 240 mg SCq4w | 0 | 47 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Controlled Period (Up to Week 16) Ligelizumab 120 mg SCq4w | 0 | 51 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Controlled Period (Up to Week 16): Placebo | 2 | 23 | |
| other | Vomiting | Gastrointestinal disorders | Any Ligelizumab 240 mg SCq4w (Subcutaneous Injection Every 4 Weeks) - Up to Week 68 | 1 | 99 | |
| other | Vomiting | Gastrointestinal disorders | Any Ligelizumab 120 mg SCq4w (Subcutaneous Injection Every 4 Weeks) - Up to Week 68 | 1 | 101 | |
| other | Injection site erythema | General disorders | Placebo Controlled Period (Up to Week 8) Ligelizumab 240 mg SCq4w | 5 | 47 | |
| other | Injection site erythema | General disorders | Placebo Controlled Period (Up to Week 8) Ligelizumab 120 mg SCq4w | 7 | 51 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Controlled Period (Up to Week 8) Ligelizumab 240 mg SCq4w | 0 | 47 |
| Total, all-cause mortality | Placebo Controlled Period (Up to Week 8) Ligelizumab 120 mg SCq4w | 0 | 51 |
| Total, all-cause mortality | Placebo Controlled Period (Up to Week 8): Placebo | 0 | 113 |
| Total, all-cause mortality | Placebo Controlled Period (Up to Week 16) Ligelizumab 240 mg SCq4w | 0 | 47 |
| Total, all-cause mortality | Placebo Controlled Period (Up to Week 16) Ligelizumab 120 mg SCq4w | 0 | 51 |
| Total, all-cause mortality | Placebo Controlled Period (Up to Week 16): Placebo | 0 | 23 |
| Total, all-cause mortality | Any Ligelizumab 240 mg SCq4w (Subcutaneous Injection Every 4 Weeks) - Up to Week 68 | 0 | 99 |
| Total, all-cause mortality | Any Ligelizumab 120 mg SCq4w (Subcutaneous Injection Every 4 Weeks) - Up to Week 68 | 0 | 101 |
| Total, other adverse events | Placebo Controlled Period (Up to Week 8) Ligelizumab 240 mg SCq4w | 21 | 47 |
| Total, other adverse events | Placebo Controlled Period (Up to Week 8) Ligelizumab 120 mg SCq4w | 17 | 51 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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