IgGenix Peanut Allergy Vaccine Study – IGNX-T1

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 Adults and Older Adolescents.

ACCELERATE PEANUT

Who can take part?

You may be able to take part if you have a peanut allergy, which can cause allergic reactions after eating or coming into contact with peanut products.

You may be eligible if you:

• Are 15 to 55 years of age
• Have a confirmed peanut allergy based on medical history and testing
• Have had a previous allergic reaction to peanut
• Meet certain allergy test requirements

You would not be able to take part if:

• You have severe asthma or certain other medical conditions
• You are pregnant or breastfeeding
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether IGNX001, an investigational inhaled treatment, may help people with peanut allergy.

• Study duration: Approximately 13 weeks (plus screening period)
• Clinic visits: 12 onsite visits during the study

The study includes:

• A screening period (up to 90 days)
• A treatment and follow-up period (approximately 12 weeks)

What will I need to do?

If you take part, you will be asked to:

• Take the study medication using a nebuliser four times a day
• Attend clinic visits and study appointments
• Take part in assessments, which may include:
• • Skin prick testing
  • Blood tests
  • A heart tracing (ECG)
  • Supervised food challenges

You will also be asked to follow certain lifestyle and medication guidelines during the study.

More information

You can read more about this study here:

• ClinicalTrials.gov – IGNX001 Study