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RecruitingPhase IIInterventional

Repair effects of leramistat in participants with rheumatoid arthritis

This research is investigating a new medication, leramistat, for individuals living with rheumatoid arthritis. The main goal is to understand how leramistat might affect muscles in people with this condition. This is a Phase II clinical trial, an early stage of research where we are testing the medicine to see if it's effective and safe, and to find the right dose. Participants will be given either leramistat or a dummy medicine (placebo) without knowing which one they receive. More detailed information about who can join and what the study involves will be shared soon, once approved by health authorities.

At a glance

Status
Recruiting
Phase
Phase II
Sponsor
Istesso Therapeutics
Enrolment target
18
Start
20 Apr 2026
Estimated completion
29 Jan 2027

What is this study about?

This research study is focused on rheumatoid arthritis, a condition where your body's immune system mistakenly attacks your own joint tissues, leading to pain, swelling, and stiffness. We are particularly interested in how a new drug, called leramistat, might help people with this condition, specifically looking at its effects on muscles.

The main idea behind this study is to see if leramistat can make a difference to the muscles of people with rheumatoid arthritis. This is an important step in understanding new treatments because sometimes conditions like rheumatoid arthritis can affect more than just the joints. By studying the muscles, we hope to learn more about the complete effects of leramistat.

This study is in its early stages, known as "Phase II." This means we are carefully testing leramistat to see if it works as expected and if it is safe for people to take. We also aim to figure out the best dose to use. To do this fairly, some participants will receive leramistat and others will receive a 'dummy' treatment (a placebo), and neither the patients nor the doctors will know who is getting which. This helps ensure the results are accurate and unbiased.

Key takeaways

  • The study is testing a new medicine, leramistat, for rheumatoid arthritis.
  • It aims to understand leramistat's effects on muscles.
  • This is an early-stage (Phase II) trial to check safety and effectiveness.
  • Participants will receive either leramistat or a dummy medicine (placebo).
  • Detailed study specific information is awaiting approval from health authorities.
  • You can discuss participation with your doctor and can withdraw anytime.

Who may be eligible?

At the moment, the full details about who can and cannot join this study are not yet available. These important rules are being reviewed by the Health Research Authority to make sure the study is safe and ethical for everyone involved.

Once approved, this information will be clearly stated. This will include specific details about your age, any other health conditions you might have, and medications you are currently taking. Generally, studies like this look for people who have been diagnosed with rheumatoid arthritis.

The study welcomes both men and women aged 18 and older. As soon as the health authorities give their approval, all the specific inclusion and exclusion criteria will be added here, so you'll know exactly if you might be a good fit.

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.

  1. Are you between 18 and 120 years old?
  2. Do you have a diagnosis of rheumatoid arthritis?
  3. Are you able to attend regular study visits?
  4. Are you prepared to potentially receive a placebo?
  5. Are you happy to wait for full eligibility criteria?
Answer every question to see your result.

What does participation involve?

Detailed information about what taking part in this study would involve is still being finalised and approved by health authorities. Once available, it will include specifics on:

* **Study Visits:** How many times you would need to visit the clinic, and how long each visit might last. * **Assessments:** What kinds of tests you would have, such as blood tests, physical examinations, or questionnaires, to check your health and how the treatment is working. * **Medication:** How you would receive leramistat or the placebo, including whether it's a pill, injection, and how often you would take it. * **Follow-up:** How often and for how long researchers will check in with you after your main treatment period finishes. * **Total Duration:** The overall length of time you would be involved in the study from start to finish. All these details are designed to ensure your safety and gather accurate information about the new medicine.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment like leramistat before it's widely available, and closely monitored medical care. You would also be contributing valuable information that could help others with rheumatoid arthritis in the future. However, there are also potential risks, as leramistat is still being tested and its full side effects are not yet known. Some people might experience side effects, and it's possible that the treatment might not work for you, or you might receive the placebo. You would always 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.
  • NIHR Newcastle Clinical Research Facility
    City only
    Newcastle upon Tyne, England

Common questions

What is leramistat?

Leramistat is a new medicine being tested in this study for people with rheumatoid arthritis. We are trying to understand its effects, particularly on muscles.

What is rheumatoid arthritis?

Rheumatoid arthritis is a condition where your body's immune system attacks its own joints, causing pain, swelling, and stiffness throughout your body.

What does 'Phase II' mean?

Phase II is an early stage of clinical research. It means we are testing the medicine carefully to see if it works, find the right dose, and check for side effects.

Will I definitely get the new medicine?

No, this is a 'randomised, double-blind, placebo-controlled' study. This means you have an equal chance of receiving either leramistat or a dummy medicine (placebo).

When will I know more about who can join?

The full details about who can join are currently being reviewed by health authorities. We expect this information to be available on or before the specified date.

How to find out more

John Isaacs

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

Discussion

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