Trial · NCT05678959
Long-term Extension Study of Ligelizumab in Food Allergy
NCT05678959, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2025-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Extension Study of Ligelizumab in Food Allergy. Trials, record NCT05678959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05678959
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Extension Study of Ligelizumab in Food Allergy
- NCT number
- NCT05678959
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 163 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Food Allergy
- Interventions
- Ligelizumab 120 mg, Ligelizumab 240 mg
- First posted
- 2023-01-10
- Last updated
- 2026-01-13
- Results first posted
- 2025-10-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Up to approximately 81 weeks | TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment. |
| Secondary | Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms | Up to approximately 97 weeks | Assessed during an open-label oral food challenge (OFC). If missing Week 52-OFC assessments, Week 156-OFC assessments were performed within 380 days (inclusive) after first extension dose date and considered as Week 52-OFC assessments. |
| Secondary | Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug | Up to approximately 81 weeks | TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment. |
| Secondary | Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Up to approximately 97 weeks | The FAQLQ-TF is a self-reported instrument designed for adolescents aged 13-17 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes three domains (emotional impact, allergen avoidance and dietary restrictions, and risk of accidental exposure). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge. |
| Secondary | Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Up to approximately 97 weeks | The FAQLQ-AF is a self-reported instrument designed for adults aged 18-55 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes four domains (emotional impact, allergen avoidance and dietary restrictions, risk of accidental exposure, and food allergy-related health). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge. |
| Secondary | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF) | Up to approximately 97 weeks | The FAIM-TF is a self-reported instrument designed for adolescents aged 13-17. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions. The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge. |
| Secondary | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF) | Up to approximately 97 weeks | The FAIM-AF is a self-reported instrument designed for adults aged 18-55. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions; The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. the range for each item and the total score is from 1 (minimum) to 7 (maximum). The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge. |
| Secondary | Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS) | Up to approximately 97 weeks | The SF-36v2 Health Survey is a 36-item instrument that measures generic health-related quality of life. It contains 8 scales and 2 component summary indices evaluating physical, social, and emotional functioning in addition to general health perceptions and mental health. PCS and MCS scores range from 0 to 100, with higher scores indicating better health outcomes. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Up to approximately 81 weeks | Safety Set 1 included all participants who received at least one dose of study treatment during the extension study. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms | Up to approximately 97 weeks | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Data are reported for participants who responded and had an evaluable value. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug | Up to approximately 81 weeks | Safety Set 1 included all participants who received at least one dose of study treatment during the extension study. Number analyzed is the number of participants with available data. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Up to approximately 97 weeks | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Unit on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Up to approximately 97 weeks | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Unit on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF) | Up to approximately 97 weeks | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Unit on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF) | Up to approximately 97 weeks | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Unit on a scale | MEAN |
| SECONDARY | Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS) | Up to approximately 97 weeks | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Unit on a scale | MEAN |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Ligelizumab 120 mg | TEAEs | 84.0 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Ligelizumab 240 mg | TEAEs | 69.5 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Ligelizumab 120 mg | TESAEs | 3.7 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Ligelizumab 240 mg | TESAEs | 2.4 | percentage of participants | |
| Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms | Ligelizumab 120 mg | 1 | Participants | ||
| Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug | Ligelizumab 120 mg | TEAEs | 86.1 | percentage of participants | |
| Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug | Ligelizumab 240 mg | TEAEs | 67.4 | percentage of participants | |
| Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug | Ligelizumab 120 mg | TESAEs | 5.6 | percentage of participants | |
| Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug | Ligelizumab 240 mg | TESAEs | 0 | percentage of participants | |
| Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Ligelizumab 240 mg | 1.13 | Standard Deviation NA | Unit on a scale |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ligelizumab 120 mg | 81 | |
| Overall Study | STARTED | Ligelizumab 240 mg | 82 | |
| Overall Study | COMPLETED | Ligelizumab 120 mg | 0 | |
| Overall Study | COMPLETED | Ligelizumab 240 mg | 0 | |
| Overall Study | NOT COMPLETED | Ligelizumab 120 mg | 81 | |
| Overall Study | NOT COMPLETED | Ligelizumab 240 mg | 82 |
Source ClinicalTrials.gov
Adverse events52
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 | Injection site erythema | General disorders and administration site conditions | Ligelizumab 120 mg | 7 | 81 | |
| other | Injection site erythema | General disorders and administration site conditions | Ligelizumab 240 mg | 14 | 82 | |
| other | Injection site induration | General disorders and administration site conditions | Ligelizumab 120 mg | 1 | 81 | |
| other | Injection site induration | General disorders and administration site conditions | Ligelizumab 240 mg | 6 | 82 | |
| other | Injection site oedema | General disorders and administration site conditions | Ligelizumab 120 mg | 4 | 81 | |
| other | Injection site oedema | General disorders and administration site conditions | Ligelizumab 240 mg | 11 | 82 | |
| other | Injection site swelling | General disorders and administration site conditions | Ligelizumab 120 mg | 2 | 81 | |
| other | Injection site swelling | General disorders and administration site conditions | Ligelizumab 240 mg | 7 | 82 | |
| other | COVID-19 | Infections and infestations | Ligelizumab 120 mg | 6 | 81 | |
| other | COVID-19 | Infections and infestations | Ligelizumab 240 mg | 7 | 82 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ligelizumab 120 mg | 0 | 81 |
| Total, all-cause mortality | Ligelizumab 240 mg | 0 | 82 |
| Total, other adverse events | Ligelizumab 120 mg | 47 | 81 |
| Total, other adverse events | Ligelizumab 240 mg | 43 | 82 |
| Total, serious adverse events | Ligelizumab 120 mg | 3 | 81 |
| Total, serious adverse events | Ligelizumab 240 mg | 2 | 82 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38814736 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ligelizumab 120 mg vs Ligelizumab 240 mg: deaths from any cause | Trial comparisons |
| Ligelizumab 120 mg vs Ligelizumab 240 mg: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05678959
GET https://conductscience.org/api/trials/v1/NCT05678959/events?page=2