RVLO 121-05 IRL201104 Allergen Sensitivity Study
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Allergen Challenge Trial of 12 Weeks of 6 Repeat Doses of IRL201104 in Adult Participants with Seasonal Allergic Rhinitis.
IRAS ID
299691
Contact name
Stephen Till
Contact email
Sponsor organisation
Revolo Biotherapeutics Ltd
Eudract number
2021-002856-35
Duration of Study in the UK
0 years, 7 months, 16 days
Research summary
The purpose of this research study is to learn about how allergic reactions to grass pollen respond to an experimental medication called IRL201104 and to learn if and how the study medicine might be able to help people with grass pollen hayfever with their symptoms.
The study medicine is not approved by any health authority for the use in clinical practice. It is not clear how IRL201104 works, but numerous studies in animals showed that the study medicine appears to help reduce inflammation caused by immune system, for example after exposure to allergens. In addition to these animal studies, IRL201104 has also been studied in more than 70 people.The study will enroll up to 60 participants with a history of summer hayfever (seasonal allergic rhinitis caused by grass pollen) for at least 2 years. Participants must have a history of moderate or severe hayfever symptoms that interfere with their usual daily activities or sleep. In addition, participants must be receiving treatment for hayfever with antihistamines or nasal corticosteroid medications during the grass pollen season, have positive responses to a skin prick test and nasal allergen challenge test, and meet other criteria.
The main objectives of this research study are to:
- Learn how patients with seasonal allergic rhinitis respond to IRL201104
- Learn more about how IRL201104 works and how safe it isThe research study is randomized and blinded. Up to 60 participants will be randomised 1:1 to receive either IRL201104 or placebo. The study duration includes screening period up to 3 weeks, 10 weeks dosing period (6 doses) and follow up 2 weeks after the last dose.
The main risk of receiving IRL201104 is mild discomfort.
Lay Summary:
Repeated doses of IRL201104 in participants with seasonal allergic rhinitis.
Sponsor code: RVLO 121-05
IRAS project ID: 299691
Full title: A phase 2a, randomized, double-blind, placebo-controlled, parallel-design, allergen challenge trial of 12 weeks of 6 repeat doses of IRL201104 in adult participants with seasonal allergic rhinitis Researchers look at the results of many studies to understand if experimental new medicines work and how they work. It takes lots of people in many studies all around the world to advance medical science. This summary shows the results from only this study. Other studies may find different results.
We are extremely grateful to the study participants who took part in this important research.
Why did we do the study?
The study medicine (IRL201104) is an experimental new treatment for grass pollen hay fever (an allergic reaction also called ‘seasonal allergic rhinitis’). We hope the study medicine will be an improvement on existing treatments and help people with their hay fever symptoms.
We tested repeated doses of the study medicine to find out if it helps people with their allergy symptoms. We also wanted to find out its side effects, blood levels, and effects on the immune system (a complex network of cells and proteins that defend the body against infection).
In this study, half the participants took the study medicine, and the other half took placebo (a dummy medicine that had no active ingredient) – a computer decided who took which. The study medicine and placebo looked the same, so neither the study doctor nor the participants knew which one they were taking. That was done to make sure the study results weren’t influenced in any way.
Who organised the study and when did it take place?
The doctors and support staff of HMR and King’s College London (KCL) (both in London, UK), organised the study. A pharmaceutical company – Revolo Biotherapeutics Limited, Great Shelford, UK (the ‘sponsor’) – paid for the study.
The study took place at HMR and KCL from 4 November 2021 until 27 March 2023. We completed the study as planned.
Who took part in the study and what treatments did they take?
60 people (33 men and 27 women) with hay fever, aged 21–60 years, took part in the study. They could only take part if they had summer hay fever (seasonal allergic rhinitis caused by grass pollen) for at least 2 years before the study started, with symptoms that affected their sleep or usual daily activities, and tested positive for certain allergy tests at screening.
Participants took repeated doses of the study medicine or placebo, as injections into a vein in the arm, once every 2 weeks for 10 weeks (6 doses in total).
What were the results of the study?
Effect of the study medicine on hay fever symptoms There were no important differences between the study medicine and placebo in the main allergy tests, but some of the results suggested the study medicine might help people with hay fever. Some people felt that their hay fever symptoms had improved after taking all their doses of the study medicine, when compared with their symptoms after the first dose.
Side effects
Side effects are unwanted medical events (such as headache) during the study that the study doctor believes may have been caused by the study medicine. In this study, we found out the following.
• There were no serious side effects – those are side effects that were life threatening or required someone to go to hospital.
• Not all people in the study had side effects.
• The most common side effects were headache and fatigue (tiredness), each reported by 2 out of 30 people who took the study medicine. However, those symptoms occurred at least as often in people who took placebo.
Other side effects, each reported by only one person who took the study medicine, included: pins and needles feeling, headache, constipation, diarrhoea, nausea (feeling sick), back pain, muscle aches, trouble sleeping, rash, and flushing (turning red).
Other results
• The study medicine was safe and well tolerated at the dose tested. There were no important changes in safety results in people who took the study medicine.
• Blood levels of the study medicine were as we expected. The body got rid of most of the study medicine within 1 hour after each dose.
• There was no sign that people produced ‘antibodies’ (an immune system defence response) to the study medicine.
How has the study helped patients and researchers?
The results of this study will be used together with results from other studies of IRL201104 to learn whether people with hay fever, and other conditions caused by the immune system, are helped by the study medicine.
Are there plans for further studies?
Further studies of IRL201104 are planned in people with other conditions caused by the immune system.
Where can I find more information about the study?
You can find out more detailed information about this study at clinicaltrials.gov.
If you would like more general information about clinical trials, the UK Clinical Research Collaboration (UKCRC) booklet ‘Understanding Clinical Trials’ has information about medical research, and questions you might want to ask. If you’d like to read it, please visit https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ukcrc.org%2Fwp-content%2Fuploads%2F2014%2F03%2FiCT_Booklet.pdf&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7C5f1cd90c6aea4047584008dc41b4767d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638457490536915326%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=SOIG2r%2BSJZBrbZAUjZP3npW6wwbkBMsUUlkJtEmCG0c%3D&reserved=0REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0199
Date of REC Opinion
22 Sep 2021
REC opinion
Further Information Favourable Opinion