Always worried about coming into contact with peanuts? Tired of avoiding restaurants and parties, or losing sleep when your child goes on school trips? 

You’re not alone. 

Food allergies are on the rise, with 1 in 12 children and 1 in 10 adults affected in the US alone1. Of all the food allergies, peanut is one of the most common. Despite this, peanut allergy management is mostly limited to emergency medication (such as epinephrine) and attempts to avoid peanuts altogether. But completely avoiding peanuts is not easy, and people with peanut allergies often come into contact with them accidentally. 

That’s why we’re conducting this clinical trial. We want to see if an investigational drug could help prevent severe allergic reactions, so that people with peanut allergies can be better protected from peanuts.

See if you’re eligible

What will this trial involve? 

This is a phase 3 interventional clinical trial and will last for approximately 17 months, as outlined below:

3 visits over approximately 1 month

We’ll carry out some tests to see if potential participants are eligible for the trial.

Approximately 17 visits over 12 months

Participants will be randomly assigned to receive either:

  • 240mg of the investigational drug (1 in 3 chance)
    or
  • 120mg of the investigational drug (1 in 3 chance) 
    or
  • A placebo (1 in 3 chance)

Participants in the placebo group will switch to receive the investigational drug at week 8 or 16.

One subcutaneous (under the skin) injection will be administered every 4 weeks.

4 visits over approximately 4 months

We’ll continue to monitor participants’ health and condition.

What is peanut allergy and how might we be able to treat it?

Young boy with father eating food at dinner table talking about peanut allergy treatment

Food allergy is a serious and potentially life-threatening medical condition caused by an overactive immune system. 

The immune system is made up of a network of cells that work together to protect the body from harm. Antibodies are one part of this network. They help the body fight harmful substances. But in people with allergies, the immune system overreacts and produces antibodies in response to harmless substances by mistake. 

When people with peanut allergy encounter peanuts, their immune system produces a type of antibody called Immunoglobulin E (IgE). IgE then binds with cells which triggers an allergic reaction2. Therefore, the investigational drug is designed to work by preventing IgE from binding to these cells, with the goal of reducing the severity of an allergic reaction.3,4
 

Who can take part?

 

Trial eligibility Yes checkbox in blue square icon

 

To take part in this clinical trial, in addition to other criteria, potential participants must be:

  • Between 12 and 55 years old (recruitment for people aged 6-12 will start later)
  • Diagnosed with allergy to peanuts or peanut-containing foods

 

Trial Eligibility No cross mark in blue square icon

 

Potential participants must not be:

  • Diagnosed with uncontrolled asthma
  • Pregnant (or likely to become pregnant) or nursing

For full eligibility criteria, please visit: clinicaltrials.gov

Participation in this clinical trial is completely voluntary.

See if you’re eligible

How will each participant’s health be monitored? 

During this trial, participants will visit a clinic approximately 24 times. This is so that we can monitor their general health and allergy with health checks, such as: 

Blood tests, blue syringe icon

Blood tests

Urine tests, blue test tube icon

Urine tests

Skin prick testing, blue microscope icon

Skin prick testing

Vital signs, blue heart icon

Vital signs

Electrocardiograms (ECGs), blue heartbeat icon

Electrocardiograms (ECGs)

Questionnaires, blue writing on sheet icon

Questionnaires

About Clinical Trials

Smiling doctor supporting  female clinical trial participant with a pat on the back

What is a clinical trial?

Every year, hundreds of thousands of people take part in clinical trials (also known as clinical studies). These are carefully controlled scientific investigations that help us improve medicine all around the world. They help us discover:

  • Alternative ways to diagnose conditions
  • Alternative ways to treat conditions
  • Alternative ways to track the progress of conditions

Clinical trials must be approved by regulatory boards before they can begin. These boards work to protect the safety and rights of trial participants. They do this by reviewing and approving the trial’s protocol – a plan that explains the need for the trials, what participants will need to do and how their health will be monitored throughout. 

Different types of clinical trials

Clinical trials help us answer scientific questions, but different types of trials help us do this in different ways. For example:  

Woman and clinical trial doctor reviewing different types of clinical trial notes

Interventional trials

Participants are asked to change their care somehow. For example, they may be asked to take an investigational drug or change their diet.  

Clinical trial nurse and clinical trial participant reviewing body weight on weighing scales

Observational trials

Participants are asked to continue their usual healthcare regimen while healthcare professionals monitor their condition. For example, the level of a certain substance (e.g. an antibody) in the blood could be monitored. 

Different phases of clinical trials  

An investigational drug must pass through several stages of clinical trials before it can be submitted for approval for general use by the public. Each stage helps us answer different questions. Only once an investigational therapy has been shown to be safe in one phase may it progress to the next. 

 

Investigators study the effects of an investigational drug in about 20 - 80 people. This phase is important for ensuring that an investigational drug is safe and helps us learn which doses may have a therapeutic effect.

These trials are conducted in a slightly larger group of about 100 - 300 people. The investigational drug may be compared with a placebo (a ‘dummy drug’) to help us learn whether it is an effective treatment and learn more about any potential side effects. 

These usually involve up to 3,000 people to help us understand more about the safety and efficacy of an investigational drug, as well as how well it compares to existing treatments for a particular condition. 

Medication approved for general use

These trials help us learn how the treatment affects people in the long-term. They only take place once a drug has been approved for general use.

Frequently Asked Questions

We’ve compiled answers to some of the most common questions about clinical trials, as well as any specific questions related to this particular trial. If you have any other questions, please contact the trial team, who will be more than happy to assist you.

About clinical trials

A placebo looks just like the investigational drug and is given in the same way. However, it contains no active ingredients. Placebos are used to be sure that any treatment effects seen are due to the investigational drug and not some other factor, such as increased visits with the trial doctors. But that doesn’t mean people in the placebo group receive no care. The health of every participant will be closely monitored throughout the trial. In this specific peanut allergy trial, participants in the placebo group will switch to receive the investigational drug at week 8 or 16.

Participation in clinical trials is voluntary. This means that you are under no obligation to take part and you are free to leave at any time without penalty. However, we would encourage all potential participants to stay in a trial for its duration, if possible.

No. You do not need medical insurance to take part in clinical trials.

Every clinical trial must be approved by regulatory boards (such as the US Food and Drug Administration) before it can begin. It is the job of these boards to protect the safety and rights of a trial’s participants. They do this by reviewing the trial’s protocol. A protocol is a plan that explains the need for the trial, what participants will need to do, and how their health will be monitored.  

Before a person can be enrolled into a clinical trial, they must meet eligibility criteria specific to that trial. 

There is no cost to participate in a trial and insurance is also not required. Study-related medications and tests are provided at no cost. Many trials may pay for travel and accommodation-related expenses too.

This will depend on the trial. You will be provided with a detailed visit schedule before you enroll.

You may well have to take time off work to make appointments at the trial’s site. Before you enroll, you will be given a detailed visit schedule so you can consider this commitment before you decide to volunteer.

Many clinical trials are ‘randomized’ and ‘double- blind’. Randomized means you will be allocated to a treatment group by chance, like the flip of a coin. Double- blind means that neither the participant nor the trial team will know which group the participant is in until after the trial is complete. This is to ensure that any effects seen are due to the investigational drug alone.

About our peanut allergy trial

The safety of all participants, the trial team and their families are our main priority. Therefore, we have put in place a number of strict safety precautions to minimize the risk of COVID-19 spreading between individuals involved in this clinical trial. All participants will be asked to comply with these measures which include: 

  • Socially distanced clinic visits (i.e. staggered appointments, reduced contact in waiting rooms and communal areas)
  • Enhanced cleaning of clinics 
  • The provision of full PPE where appropriate
  • Hand sanitization points
     

To participate in our study you will need to have a peanut allergy and be aged between 6 and 55 years old. To see the full eligibility criteria please visit clinicaltrials.gov.

There is a 2 in 3 chance that you will receive the investigational drug. Please note, all participants in the placebo group will switch to receive the investigational drug at week 8 or 16. Please see above to find out more about what this trial involves.

As a caregiver you will have certain time commitments, such as accompanying your child to all of their trial visits. We would also like to reassure you that your child’s health will be closely monitored throughout the trial if you decide to enroll them. More information and guidance will be provided by staff at trial sites.

Find out if you can take part

Our clinical trial is evaluating an investigational drug that could prevent severe allergic reactions to peanuts.  

See if you’re eligible
  1. Warren CM, Jiang J, Gupta RS (2020) Epidemiology and Burden of Food Allergy. CurrAllergy Asthma Rep; 20(2):6
  2. Sampson HA, Muñoz-Furlong A, Campbell RL, et al (2006) Second symposium on the definition and management of anaphylaxis: summary report-Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J. Allergy Clin. Immunol.; 117(2):391-7
  3. Arm JP, Bottoli I, Skerjanec A, et al (2014) Pharmacokinetics, pharmacodynamics and safety of QGE031 (ligelizumab), a novel high-affinity anti-IgE antibody, in atopic subjects. Clinical & Experimental Allergy; 44:1371–85.
  4. Gauvreau GM, Arm JP, Boulet LP, et al (2016) Efficacy and safety of multiple doses of QGE031 (ligelizumab) versus omalizumab and placebo in inhibiting allergen-induced early asthmatic responses. J. Allergy Clinical Immunology; 138(4):1051-1059