RecruitingPHASE1INTERVENTIONAL

Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)

This clinical trial is designed to understand more about a new medicine, JTE-162, for adults aged 18 to 80 who have a rare inflammatory condition called Cryopyrin-Associated Periodic Syndromes (CAPS). CAPS can cause symptoms like skin rashes, joint pain, and fevers. We want to find out if JTE-162 is safe to use, whether people can take it without too many side effects, and if it helps to improve CAPS symptoms. Participants in the study will take JTE-162 once a day for two weeks. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people with CAPS.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Akros Pharma Inc.

Enrolment target

Start

02 Feb 2026

Estimated completion

01 Dec 2026

Cryopyrin-associated Periodic Syndromes (CAPS)

What is this study about?

This research study is looking at a new medicine called JTE-162. It's for people who have a rare group of conditions known as Cryopyrin-Associated Periodic Syndromes, or CAPS. CAPS are conditions where the body's immune system overreacts, causing repeated episodes of inflammation. This can lead to symptoms such as skin rashes, muscle and joint pain, fevers, and feeling very tired.

The main goal of this study is to learn more about JTE-162. We want to see if it's safe for people with CAPS, and if they can tolerate taking it without many problems. We also want to find out if this new medicine can help reduce the symptoms of CAPS and how it behaves in the body once it's taken.

This is an early-stage study, which means it helps us understand the medicine better before it can be considered for wider use. By taking part, you could be helping to advance our understanding and potentially develop new treatments for CAPS in the future.

Key takeaways

This study is testing a new medicine, JTE-162, for CAPS.
It aims to check if the medicine is safe and if it helps CAPS symptoms.
Participation involves taking medicine once daily for two weeks.
You must be an adult with diagnosed FCAS or MWS and experiencing a flare-up.
You may need to pause other CAPS medications for the study.
Your health will be closely monitored throughout your participation.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old and have a confirmed diagnosis of either Familial Cold Autoinflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS). These are specific types of CAPS. Your doctor will need to have seen at least two typical symptoms of CAPS, such as a specific type of skin rash, muscle or joint pain, repeated fevers, or eye irritation. You also need to have a confirmed genetic change (called an NLRP3 mutation) that is linked to CAPS.

During an initial check-up period, you must be experiencing a flare-up of your CAPS symptoms. If you are currently taking other medicines for CAPS that target a specific protein called IL-1, you must be willing to temporarily stop taking them for the study. Your study doctor will discuss this with you carefully.

You cannot join the study if you have another type of CAPS called Chronic Infantile Neurologic Cutaneous Articular Syndrome (CINCA) or Neonatal-Onset Multisystem Inflammatory Disease (NOMID). You also can't participate if you have a history or signs of certain serious health issues like conditions affecting your kidneys (amyloidosis), worsening hearing loss, significant organ damage, or if stopping your current IL-1 medicine would be risky for you. Anyone with an active serious infection within 14 days before the start of the study, or a history of frequent, serious infections, would also not be able to take part.

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 80 years old?
Do you have a diagnosis of FCAS or Muckle-Wells Syndrome (MWS)?
Are you currently having a flare-up of your CAPS symptoms?
Are you willing to temporarily stop other CAPS medicines (if currently taking them)?
Do you not have CINCA/NOMID or other specific serious health conditions?
Do you not have an active serious infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, JTE-162, once a day for two weeks. During this time and for a period after, you would have several visits to the study clinic. These visits will involve various tests and checks to monitor your health, see how you are responding to the medicine, and check for any side effects. These could include blood tests, physical examinations, and questions about your symptoms and how you are feeling. The exact number and timing of visits, as well as the total length of your involvement in the study, would be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving a new investigational medicine that could help your condition or receiving close medical attention. However, there are also potential risks, including side effects from the study medicine, discomfort from procedures like blood tests, or the possibility that the medicine may not help your symptoms. You will be closely monitored for any side effects or changes in your health. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Gordon Sussman Clinical Research Inc.
City only
North York, Canada· Recruiting

Common questions

What are Cryopyrin-Associated Periodic Syndromes (CAPS)?

CAPS are a group of rare, lifelong inflammatory conditions that cause repeated attacks of symptoms like fever, skin rash, and joint pain.

What is JTE-162?

JTE-162 is a new medicine being tested to see if it can help reduce inflammation and symptoms in people with CAPS.

How long will I take the study medicine?

Participants in this study will take the medicine once a day for two weeks.

Will I have to stop my current CAPS medication?

If you are currently on certain CAPS medications (anti-IL-1 treatments), you might need to temporarily stop them for the study. This will be discussed with your doctor.

What 'phase' is this study?

This is a Phase 1 study, which means it's an early-stage study primarily focused on checking the safety and how well people tolerate the new medicine.

How to find out more

Takanori Nemoto, M.S.

clinicaltrials@akrospharma.com 609-919-9570 Official trial record

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