Evaluating a new treatment for peanut allergy
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study With Single Blind Sentinel Period to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IGNX001 in Peanut-Allergic Participants
This study is testing a new treatment for peanut allergies in adults and older teens to see if it’s safe and how well it works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 15 Years to 55 Years |
| Sex | All |
| Sponsor | IgGenix Australia Pty Ltd Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 4 sites (Darlinghurst, New South Wales and 3 other locations) |
| Trial ID | NCT06331728 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new treatment called IGNX001 in adults and older adolescents with peanut allergies. It employs a randomized, double-blind, placebo-controlled methodology, where participants will receive either the treatment or a placebo in a single ascending dose format. The study aims to gather data on how the body processes the treatment and its effects on peanut allergy symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults and older adolescents with a diagnosed peanut allergy who have experienced allergic reactions to peanuts within the last 15 years.
Not a fit: Patients who have had severe anaphylaxis requiring intensive care within the past year or those currently undergoing food allergen immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of peanut allergies, potentially reducing the risk of severe allergic reactions.
How similar studies have performed: While this approach is novel, previous studies on immunotherapy for food allergies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * History of physician-diagnosed peanut allergy with clinical reaction to peanut within 2 hours of exposure to peanut or peanut-containing food (within the last 15 years). * Peanut specific IgE level ≥ 1 kUA/L. * Positive peanut SPT with wheal diameter ≥ 5 mm. Key Exclusion Criteria: * History of severe or life-threatening anaphylaxis requiring intubation or admission to intensive care unit within 1 year prior to Screening. * Current, or within the past year, treatment with food allergen immunotherapy or participation in a food allergy immunotherapy study. * Current treatment with aeroallergen immunotherapy, except if on stable monthly maintenance SC aeroallergen immunotherapy.
Where this trial is running
Darlinghurst, New South Wales and 3 other locations
- St Vincent's Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
- Monash Health, Sleep, Allergy, and Immunology — Clayton, Victoria, Australia (Recruiting)
- Royal Melbourne Hospital — Parkville, Victoria, Australia (Recruiting)
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Jessica Grossman, MD
- Email: jgrossman@iggenix.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.