IgGenix ACCELERATE Peanut Study (In-Progress/ Currently Recruiting)

IgGenix ACCELERATE Peanut Study (In-Progress/ Currently Recruiting)

  • Status: In-Progress/ Currently Recruiting
  • Name of Research Study: IgGenix ACCELERATE Peanut Study (Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001)
  • Area of Allergy Research: Food Allergies (Peanuts)
  • Research for: Teens and Adults
  • Purpose of Study: The study will help understand if IGNX001 can be used to help ease allergic reactions that might happen after accidental peanut exposure. It will monitor the safety of IGNX001, track how participants respond to it, and explore whether participants improve their tolerance to peanut protein exposure after receiving IGNX001.
  • Location of Study: Western Australia, New South Wales and Victoria
  • Conducted By: IgGenix Australia Pty Ltd
  • ClinicalTrials.gov ID: NCT06331728
  • Ethics: This study has been approved by the South Metropolitan Health Service Human Research Ethics Committee and Bellberry Human Research Ethics Committee.

About the IgGenix ACCELERATE Peanut Study

If Adults or Teens have been diagnosed with severe peanut allergy, they may be eligible to take part in a new study exploring whether the investigational medicine called IGNX001 can help treat peanut allergy in teens and adults.

IGNX001 is a monoclonal antibody-based therapeutic for peanut allergy.

Phase 1 Overview
The phase 1, randomised, double-blind study will evaluate the safety and tolerability of an injectable, allergen-specific antibodies that targets peanut protein.

The study will help understand if IGNX001 can be used to help ease allergic reactions that might happen after accidental peanut exposure. It will monitor the safety of IGNX001, track how participants respond to it, and explore whether participants improve their tolerance to peanut protein exposure after receiving IGNX001.

The study is recruiting participants at Fiona Stanley Hospital (Western Australia), St Vincent’s Hospital (New South Wales), The Royal Melbourne Hospital and Monash Health (Victoria).​

How the study runs

The study runs for up to six months, and involves:

  • Regular visits to the selected study centre
  • Receiving up to four injections
  • Undertaking a series of tests and assessments to monitor the participants health during the study, including their medical history, prior and current medications, physical exams, blood and urine samples, electrocardiograms (ECG), skin prick tests and peanut oral food challenges.
  • For more information on the study, visit https://www.clinicaltrials.gov/study/NCT06331728 (external link)

Eligibility and who can join

To pre-qualify for this study, participants (adults or teens) must:

  • Be 15 to 55 years old (Only Fiona Stanely Hospital and Monash Health are recruiting teens aged 15-18)
  • Have a history of severe peanut allergy, including having experienced a serious allergic reaction to peanut in the past 15 years
  • Be willing to avoid peanuts and other allergy inducing foods during the study
  • Have been prescribed an adrenaline autoinjector (EpiPen or Anapen)

Interested participants cannot take part in the study if they have:

  • A history of severe or uncontrolled asthma within the past six months
  • Any clinically significant liver, kidney, cardiac or mast cell disease or uncontrolled chronic disease
  • Received food allergen immunotherapy treatment or participated in a similar study in the past 12 months​

Trial Site Locations and How to Join

The study is currently recruiting participants at four study sites. If you are interested in joining the trial or interested in enrolling your teen, reach out to your local study site.

This research has been approved by the South Metropolitan Health Service HREC (for all sites outside of NSW) & Bellberry HREC (NSW).

Where to find further information

This information was provided to Allergy Life Australia by IgGenix Australia Pty Ltd. This Page was last updated on 16th December 2024.

 

Allergy Life Australia highlights allergy research studies and trials being conducted to keep the community informed. Unless detailed, Allergy Life Australia is not affiliated with any of the allergy research studies and trials listed and does not endorse or sponsor them. All study details, including eligibility, participation, and outcomes, are managed entirely by the respective study organisers or institutions. For specific questions or concerns regarding a study, please contact the organisers directly. Participation in any allergy research study and trial is voluntary and at your own discretion.

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