Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

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.
Secondary	Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)	Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))	The Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (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 (EI), Allergen Avoidance and Dietary Restrictions (AADR) and Risk of Accidental Exposure (RAE)). Each item is scored on a 7-point scale (coded as 1-7 in analysis), with a higher score indicating greater impairment in HRQoL. The total score and the domain scores are calculated as the arithmetic average of all completed items. If more than one item in any domain is missing, a domain score should not be calculated for that case. However, a total score could still be calculated if 20% or fewer of the items are missing. Therefore, the range for each item, domain, and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL.
Secondary	Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF)	Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))	The Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (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 (EI), Allergen Avoidance and Dietary Restrictions (AADR), Risk of Accidental Exposure (RAE) and Food Allergy Related Health (FAH)). Each item is scored on a 7-point scale (coded as 1-7 in analysis), with a higher score indicating greater impairment in HRQoL. The total score and the domain scores are calculated as the arithmetic average of all completed items. If more than one item in any domain is missing, a domain score should not be calculated for that case. However, a total score could still be calculated if 20% or fewer of the items are missing. Therefore, the range for each item, domain, and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL.
Secondary	Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF)	Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))	The Food Allergy Independent Measure (FAIM) - Teenager Form (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. Each question is scored on a 7-point scale (coded as 1-7 in analysis), with a greater score indicating a higher level of perceived risk or chance of adverse events occurring. The total score is calculated as the arithmetic average of all completed items. If less than 80% of the items within the score are complete, the total score is not calculated. Therefore, the range for each item and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring.
Secondary	Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF)	Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))	The Food Allergy Independent Measure (FAIM) - Adult Form (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. Each question is scored on a 7-point scale (coded as 1-7 in analysis), with a greater score indicating a higher level of perceived risk or chance of adverse events occurring. The total score is calculated as the arithmetic average of all completed items. If less than 80% of the items within the score are complete, the total score is calculated. Therefore, the range for each item and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring.
Secondary	Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS)	Baseline, Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))	The SF-36v2 Health Survey is a 36-item instrument that measures generic health-related quality of life. It is designed for use in surveys of general and specific populations, health policy evaluations and clinical practice and research. It contains 8 scales and 2 component summary indices evaluating physical, social and emotional functioning in addition to general health perceptions and mental health. Responses to items allow for direct calculation of scale scores, while the physical component summary (PCS) and mental component summary (MCS) scores are computed from weighted scale scores. For all scales and summary measures, higher scores indicate better health outcomes (PCS and MCS scores range 0 to 100).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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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)

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