What is research and why it’s important:

Research is essential to find out which treatments work better for patients. Testing the safety and effectiveness of drugs and devices plays an important role in discovering new treatments, and making sure that we use existing treatments in the best possible ways. Aiming to fill gaps in knowledge and changing the way that healthcare professionals work.

Clinical Research Objectives:

Diagnose diseases and health problems

Improve the quality of life for people living with illness

Treat illness to improve survival rates or increase the number of people who are cured

Design clinical trials to safely test new drugs, devices, vaccines or ways of using known treatments

Prevent the development or recurrence of disease and reduce the number of people who become ill

Current Clinical Trials:

ARC008

Purpose: This is a phase III study, international, open-label, long-term safety study of an AR101 CODIT regimen in peanut-allergic children and adults. Subjects entering ARC008 will originate from a current Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a potential post-study option in the parent study protocol.

AR101, also known as Palforzia, is the brand name of an oral immunotherapy (OIT) that has received US Food and Drug Administration (FDA) approval to be marketed in the United States. Palforzia is intended to treat children ages 4 to 17 that have been diagnosed with a peanut allergy. It is estimated that 2.2% of children in the US are allergic to peanuts.

EPITOPE

Purpose: This is a phase III study focusing on Viaskin® Peanut, an experimental drug using a specially designed patch applied on the skin that contains a dry extract of peanut proteins. The small amount of peanut proteins in the patch is designed to desensitize (or make less sensitive) a peanut-allergic person by repeated exposures to very low amounts of peanut. This means that the objective of the product would be to prevent or at least to minimize the severity of the allergic reaction(s) if peanuts are eaten accidentally by a peanut-allergic patient after desensitization with Viaskin® Peanut patch.

The aim of the EPITOPE trial is to study the safety and efficacy of Viaskin® Peanut in young children aged between 1 and 3 years with peanut allergy.

EPOPEX

Purpose: This is a phase III follow-up study focusing on Viaskin® Peanut, an experimental drug using a specially designed patch applied on the skin that contains a dry extract of peanut proteins. This is an open-label, follow-up study for subjects who completed the EPITOPE study.

This study will be conducted in an “open-label” manner. This means that in the EPOPEX study, the drug and the dose that your child will receive are known. All children in EPOPEX will receive the active patch: Viaskin^® Peanut 250 µg. However, as the EPITOPE study will still be ongoing in a blinded manner for several months, you will not know if your child received the active or the placebo patch in EPITOPE until the EPITOPE study is unblinded, which is planned to occur before your child reaches 24 months of participation in EPOPEX (around the third quarter of 2020).

Astellas 0892-CL-1002

Purpose: This is a phase I study to determine the pharmacodynamics, safety and tolerability of multiple doses of ASP0892 administered in children.

“Pharmacodynamics” look at what the drug does to the body. “Tolerability” is a measure to see if your child’s body works in a normal way after the study drug vaccine is given. This is important because it will help determine how the study drug vaccine may be used safely in children with as few side effects as possible. We want to find out if the study drug “ASP0892” is safe to use for your child’s condition, to find a safe dose to use in future studies, and to find out what side effects ASP0892 has in people with peanut allergy. ASP0892 is an experimental drug. This means that the US Food and Drug Administration (FDA) has not approved ASP0892.