Long-term Extension Study of Ligelizumab in Food Allergy

Novartis

Status and phase: Terminated; Phase 3

Conditions: Food Allergy

Treatments: Drug: Ligelizumab 120 mg; Drug: Ligelizumab 240 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05678959

2022-502366-25-00 (EU Trial (CTIS) Number)

CQGE031G12303B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 163 patients

Sex: All

Ages: 6 to 57 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

163 participants in 2 patient groups

Ligelizumab 120 mg

Experimental group

Description:

Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.

Treatment:

Drug: Ligelizumab 120 mg

Ligelizumab 240 mg

Experimental group

Description:

Participants received ligelizumab 240 mg every 4 weeks.

Treatment:

Drug: Ligelizumab 240 mg