Long-term Extension Study of Ligelizumab in Food Allergy

Phase 3TerminatedNCT05678959

Novartis Pharmaceuticals163 enrolled

Overview

This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.

This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III "core" studies to roll over to this extension study once the participants had completed predefined minimal requirements of a "core" study and agreed to consent to participate in this study. Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness. A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

163

Conditions

Food Allergy

Interventions

Ligelizumab 120 mgDRUG

1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks

Ligelizumab 240 mgDRUG

2 injections of 1.0 mL ligelizumab every 4 weeks

Eligibility

Sex: ALLMin age: 6 YearsMax age: 57 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Signed informed consent and or/assent (where applicable) obtained from participant/legal representative prior to enrolling in the rollover study and receiving study medication. If a minor participant providing assent reached the age of legal majority (as defined by local law), he/she was to be re-consented at the next study visit. * Participants had completed the treatment period in any ligelizumab's Phase III studies in food allergy. * Participants who were willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge). * Participants who agreed to continue avoiding exposure to allergens (per core study) and any other foods they were allergic to throughout this study. * Participants who were able to safely continue into the study as judged by the investigator. Key Exclusion Criteria: * Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or intensive care unit (ICU) admission during the core studies. * Development of a serious adverse event which was suspected to be related to the study treatment judged by the investigator during the core study. * Development of uncontrolled asthma during the core study that compromised the safety of the participants judged by the investigator. * Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator. * Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion, should not participate in this extension study. * Platelets \<75,000/ul at end of treatment of the core study.

Locations (49)

Outcomes

Primary Outcomes

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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.

Time frame: Up to approximately 81 weeks

Secondary Outcomes

Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms

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.

Time frame: Up to approximately 97 weeks

Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug

Time frame: Up to approximately 81 weeks

Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)

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.

Data from ClinicalTrials.gov

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