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Food allergy drug safety trial ends early

NCT ID NCT05678959

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of ligelizumab, an injectable drug, in 163 people with food allergies who had already completed earlier Phase III studies. Participants received either 120 mg or 240 mg of ligelizumab every 4 weeks. The study was terminated, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ligelizumab (an injectable drug)
What this could lead to
If successful, this could show that ligelizumab is safe for long-term use and may help control food allergies.
What could go wrong
The study was terminated early, so results are limited. It is an extension study, not a new treatment test, and long-term safety is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

163 people

The number who actually took part.

Started

Apr 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 57 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

food allergy Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Food allergy

Contacts and locations

Locations

  • Allergy and Asthma Associates of Santa Clara Vally Center

    San Jose, California, 95117, United States

  • Allergy and Asthma Clin Res Inc

    Walnut Creek, California, 94598, United States

  • Allergy and Immunology Associates

    Scottsdale, Arizona, 85251, United States

  • Allervie Clinical Research

    Birmingham, Alabama, 35209, United States

  • Ann and Robert H Lurie Childs Hosp

    Chicago, Illinois, 60611, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Asthma and Allergy Associates P C

    Colorado Springs, Colorado, 80907, United States

  • Atlanta Allergy and Asthma Clinic

    Marietta, Georgia, 30062, United States

  • Boston Childrens Hospital

    Boston, Massachusetts, 02215, United States

  • Childrens Healthcare of Atlanta

    Atlanta, Georgia, 30342, United States

  • Childrens Hospital Of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Childrens Hospital MC

    Cincinnati, Ohio, 45229-3039, United States

  • Family Allergy and Asthma

    Lousiville, Kentucky, 40217, United States

  • Johns Hopkins Childrens Center

    Baltimore, Maryland, 21287, United States

  • Mt Sinai Medical Center

    New York, New York, 10029-6574, United States

  • Northwell Health

    New York, New York, 10028, United States

  • Novartis Investigative Site

    Brisbane, Queensland, 4101, Australia

  • Novartis Investigative Site

    Parkville, Victoria, 3052, Australia

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009, Australia

  • Novartis Investigative Site

    Hamilton, Ontario, L8N 3Z5, Canada

  • Novartis Investigative Site

    Ottawa, Ontario, K1Y 4G2, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M3B 3S6, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1C5, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1V 4W2, Canada

  • Novartis Investigative Site

    Angers, France, 49933, France

  • Novartis Investigative Site

    Lille, 59000, France

  • Novartis Investigative Site

    Toulouse, 31400, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60596, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 252-0392, Japan

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 157-8535, Japan

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Esplugues, Barcelona, 08950, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Respiratory Medicine Research Institute of Michigan

    Ypsilanti, Michigan, 48197, United States

  • Seattle Allergy and Asthma Rsch

    Seattle, Washington, 98115, United States

  • Texas Childrens Hospital

    Houston, Texas, 77030, United States

  • UBMD Pediatrics

    Buffalo, New York, 14203, United States

  • UCHealth Outpatient Pavilion

    Aurora, Colorado, 80045, United States

  • Univ of South Florida Asthma Allergy and Immunology CRU

    Tampa, Florida, 33613, United States

  • University Of NC At Chapel Hill

    Chapel Hill, North Carolina, 27599 9500, United States

  • University of Michigan Clinical Trials Office

    Ann Arbor, Michigan, 48109, United States

  • Unv of TX Southwestern Medical Center

    Dallas, Texas, 75235, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.