ARIAS Study

Welcome to the

Does Hay Fever spoil your summer?

The ARIAS Study is a clinical research study, which is looking to assess the effect of an investigational drug, IRL201104, on the allergic response in subjects who are known to be allergic to grass pollen.

We are currently recruiting adults aged 18-65 with a history of grass pollen induced allergic rhinitis for at least 2 years with heavy symptoms in May, June, or July.

This is a Phase 2a randomised, double-blind, placebo-controlled, parallel-design, allergen challenge 12-week study of IRL201104 versus placebo in adult participants with seasonal allergic rhinitis otherwise known as hay fever.

This trial may provide evidence to support the mechanism of action (how exactly the drug works), the dose and the duration of dosing of IRL201104. This information will help design a larger trial to study treatments for conditions such as yours.

Grass Allergy

Allergies happen when your immune system overreacts to a substance (an allergen such as grass pollen) that would otherwise be harmless. Hay fever, also called allergic rhinitis, affects around 25% of the UK and European population. Its symptoms generally include itchy, runny or stuffy nose and sneezing, and it can have a major impact on quality of life.

Current treatment for seasonal grass allergy includes taking over the counter or prescription medications to help reduce the symptoms, although they do not eliminate the allergy.

Before enrolling in the study, participants will be provided detailed information about all study visits and related tests and procedures.
Eligible participants will be randomized on Day 1 in a 1:1 ratio to receive either IRL201104 or placebo (a dummy medicine that looks the same as the study medicine but has no active ingredient), and will enter the double-blind treatment period. This means that neither you nor the study doctor will know if you are receiving IRL201104 or placebo.

IRL201104(8 mg) or matching placebo treatment will be given by an intravenous injection on Day 1 and thereafter once every 2 weeks for 10 weeks (6 total doses in the treatment period). Participants will return at Week 12 for the final study visit.
If you are eligible to participate in the study, you will receive compensation for your travel expenses.

Study Visits

The total study length is 12 weeks. The study visits are summarized below:

Visits every 2 weeks to provide treatment and monitor your general health and hay fever symptoms

FAQs

Revolo Biotherapeutics is a UK and USA based biotech company founded in 2011. It is dedicated to development of treatments for multiple autoimmune and allergic diseases. The company aims to develop therapies that achieve superior long-term remission with less frequent treatment dosing and without suppression of the immune system for patients with autoimmune and allergic diseases. Visit www.revolobio.com to learn more.

Professor Stephen Till, Professor of Allergy/Consultant Physician (Adult Allergy)

Stephen Till is a Professor of Allergy at King’s College London and Consultant Allergist at Guy’s & St Thomas’ Hospitals, where he was appointed in 2011. He graduated from Oxford University before pursuing a PhD in the immunological mechanisms of allergy at the National Heart and Lung Institute, Imperial College London. He received his specialist certification in Allergy in 2011.

Dr Olympia Tsilochristou, Consultant Allergist

Olympia Tsilochristou has over 10 years of experience in Allergy and is a Consultant Allergist at the UK’s largest Department of Allergy at Guy’s and St Thomas’ Foundation Trust in London.

Why do we need to conduct clinical trials?

The goal of clinical trials is to determine if a potentially new treatment works and is safe. Clinical trials also look at new ways to prevent, detect, or treat disease. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future. That is why we need your help to ensure research can continue and we can aid in developing the medicines and treatments of tomorrow.

Are Clinical Trials safe and are there any side effects

Before a clinical trial of a new medicine can begin, a government agency called the Medicines and Healthcare products Regulatory Agency (MHRA) needs to review and authorise it. The MHRA inspects sites where trials take place to make sure they’re conducted in line with good clinical practice.

Additionally, all medical research involving people in the UK, whether in the NHS or the private sector, has to be approved by an Independent Research Ethics Committee. The committee protects the rights and interests of the people who will be in the trial and ensures that each trial maintains the highest levels of safety before allowing it to proceed.

Phase 1 trials:

The drug is being studied in human volunteers for the first time.
Researchers test for side effects and calculate what the right dose might be used for treatment.

Phase 2 trials:

• The new medicine is tested on a group of people with a medical condition. These are usually short-term studies and are used help decide if a medicine could be effective and warrants testing in larger Phase 3 trials.

Phase 2A trials:

Phase 2a studies are usually pilot studies designed to evaluate signals of clinical efficacy or biological activity (‘proof of concept studies”)

Phase 3 trials:

The medicine is tested in larger groups of people with a medical condition to see if it is effective and better than placebo or an existing treatment and also if it has important side effects.

Study LocationS

The ARIAS clinical study is led by Professor Stephen Till.

The study will be conducted in:

1. Clinical Research Facility, Guy’s Hospital, Great Maze Pond, London, SE1 9RT, and

2. Hammersmith Medicines Research (HMR), 44 Cumberland Avenue, London NW10 7EW

Contact Us

For more information about the ARIAS Study, please contact the study site below:

Clinical Research Facility, Guy’s Hospital: Call us on 020 7188 2600, email us at ARIAS.STUDY@gstt.nhs.uk

HMR: email us at recruit@hmrlondon.com.