Long-term Ligelizumab for Food Allergy

Recruiting in Palo Alto (17 mi)

+85 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing the long-term safety and effectiveness of ligelizumab, a medication for food allergies. Ligelizumab is a new type of medication that has shown promise in treating certain allergic conditions and is now being tested for food allergies. It works by blocking proteins that trigger allergic reactions, helping to prevent symptoms. It is being tested on people who have already participated in an earlier study of this medication.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for individuals who have completed a Phase III study of ligelizumab for food allergies. They must be willing to follow the study's schedule, avoid allergens, and participate in oral food challenges. People with severe allergic reactions during previous studies, uncontrolled asthma, or significant health issues that could affect safety are not eligible.

Inclusion Criteria

Signed informed consent and assent form (where applicable)

Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy

I am willing to follow the study's schedule, get injections, and do the food challenge.

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Exclusion Criteria

I experienced a severe side effect suspected to be caused by the study treatment.

My asthma got worse during the study and could be unsafe for me.

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

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Treatment Details

Interventions

Ligelizumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing long-term effects of two doses of ligelizumab (120 mg and 240 mg) on people with food allergies. It aims to understand the ongoing safety and effectiveness after initial positive results from earlier trials.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Ligelizumab 240 mgExperimental Treatment1 Intervention

240 mg

Group II: Ligelizumab 120 mgExperimental Treatment1 Intervention

120 mg