RecruitingPHASE1, PHASE2INTERVENTIONAL

EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)

The EAST-1 study is looking into a new oral medication, GRWD0715, for a condition called axial spondyloarthritis (AxSpA). AxSpA causes inflammation mainly in your lower back and spine. The medicine works by targeting a specific enzyme in your body, ERAP1, which is thought to mistakenly activate your immune system to attack your own joints. By blocking this enzyme, researchers hope to stop the immune system from causing inflammation and slow down the disease’s progress. The study will first check the medicine's safety in healthy volunteers, then in people with AxSpA, and finally compare it to a dummy treatment (placebo) to see how well it works. This research is in its early stages (Phase 1 and 2).

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Grey Wolf Therapeutics

Enrolment target

141

Start

28 Jul 2025

Estimated completion

30 Sep 2028

Axial Spondyloarthritis (AxSpA)

What is this study about?

This study, called EAST-1, is exploring a new tablet treatment, GRWD0715, for axial spondyloarthritis (AxSpA). AxSpA is a long-term condition that causes pain and stiffness, mainly in the joints of your lower back and spine, because your body's immune system mistakenly attacks them. The new medicine is designed to stop this attack by targeting a specific process in your body.

Here's how it's thought to work: Your body has an enzyme called ERAP1. In AxSpA, we believe this enzyme might accidentally create tiny molecules from your own body that your immune system mistakes as harmful. When your immune system sees these 'mistaken' molecules, it reacts by causing inflammation, leading to your symptoms. GRWD0715 aims to block the ERAP1 enzyme, stopping it from creating these harmful-looking molecules. The idea is that if these molecules aren't created, your immune system won't be triggered, and the inflammation in your joints should reduce.

Ultimately, researchers hope that by calming down the immune system, GRWD0715 could help stop the progress of AxSpA and reduce the pain and discomfort it causes. This study is an important step in finding new ways to manage this condition.

Key takeaways

This study is testing a new oral medicine for axial spondyloarthritis (AxSpA).
It aims to reduce inflammation by targeting a specific enzyme in the body.
The study includes healthy volunteers and people with AxSpA.
It will check for both safety and how well the treatment works.
Some participants with AxSpA may receive a placebo (dummy medicine).

Who may be eligible?

This study is looking for two main groups of people: healthy volunteers and people diagnosed with Axial Spondyloarthritis (AxSpA).

If you have AxSpA, you should be between 18 and 65 years old. Your doctor must have confirmed you have AxSpA, and you need to show signs of active inflammation, either through an MRI scan of your lower back joints or a blood test indicating inflammation. Your symptoms should have been ongoing for at least three months, and started before you were 40. Your current treatment for AxSpA, such as NSAIDs, needs to not be fully controlling your symptoms, or you might not be able to take NSAIDs. You might also be eligible if you've tried one or two other types of medicine (like biologics) for AxSpA and they either didn't work well enough or caused side effects.

For healthy volunteers, you should be between 18 and 55 years old, generally healthy, and a non-smoker or have stopped smoking at least six months ago. Your Body Mass Index (BMI) should be between 19 and 30. Everyone taking part, both healthy volunteers and people with AxSpA, must be willing to follow strict contraception guidelines if needed.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old (if you have AxSpA)?
Have you been diagnosed with Axial Spondyloarthritis (AxSpA)?
Do you have signs of active inflammation from an MRI or blood test?
Are your AxSpA symptoms not fully controlled by current treatments, or can you not take them?
Are you willing to follow contraception rules if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the study drug, GRWD0715, as a tablet to take by mouth. The study is split into several parts. Healthy volunteers will receive a single dose to check safety. For people with AxSpA, you might receive several doses over a period of time, and some participants will receive a dummy pill (placebo) instead of the active drug, so we can compare the effects fairly. Your participation will involve regular visits to the clinic for medical checks, blood tests, and possibly MRI scans to see how you're responding and to monitor your health. The total duration of your involvement will depend on which part of the study you are in, and this will be fully explained to you before you decide to take part.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available and closer medical monitoring of your condition. However, there are also potential risks; the new medicine might cause side effects, some of which we may not yet know about, and it might not help your condition. You will be told about all known risks before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

University of the Sunshine Coast (UniSC)
Verified postcode
Birtinya, Australia· Recruiting
University of the Sunshine Coast (UniSC)
Verified postcode
Morayfield, Australia· Completed
The Colin Bayliss Research and Teaching Unit
Verified postcode
Perth, Australia· Not yet recruiting
Pioneer Clinical Research
Verified postcode
Sydney, Australia· Recruiting
University Ghent
Verified postcode
Ghent, Belgium· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
Rheumazentrum Ruhrgebiet, Ruhr-University Bochum
Verified postcode
Bochum, Germany· Recruiting
Universitätsklinikum Erlangen - Medizinische Klinik 3
Verified postcode
Erlangen, Germany· Not yet recruiting
Amsterdam University Medical Center
Verified postcode
Amsterdam, Netherlands· Recruiting
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
Verified postcode
Leiden, Netherlands· Not yet recruiting
ETG Lublin
Verified postcode
Lublin, Poland· Not yet recruiting
Reumedika
Verified postcode
Poznan, Poland· Not yet recruiting

Common questions

What is axial spondyloarthritis (AxSpA)?

AxSpA is a long-term condition that causes inflammation in your joints, particularly in your lower back and spine, leading to pain and stiffness.

What is GRWD0715?

GRWD0715 is a new oral medicine being tested. It aims to calm down the immune system to reduce inflammation in people with AxSpA.

What does 'placebo-controlled' mean?

It means some participants will receive the active drug, while others will get a dummy pill (placebo) that looks the same but contains no medicine. This helps researchers compare the effects accurately.

Why are healthy volunteers taking part?

Healthy volunteers help us first check if the new medicine is safe and how it's processed by the body before it's tested in people with the condition.

Will I know if I'm getting the real medicine or the placebo?

No, initially you won't know. This is to ensure the results are unbiased. Your doctor will know if it's medically necessary.

How to find out more

Grey Wolf Therapeutics Patient enquiries

enquiries@gwt.bio +44 1235644970 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.