AuthorisedTherapeutic exploratory (Phase II)Interventional

DECISION ON OPTIMAL COMBINATORIAL THERAPIES IN IMMUNE-MEDIATED INFLAMMATORY DISEASES (IMIDS) USING SYSTEMS APPROACHES

This research study is for adults in the UK who have Psoriatic Arthritis or Rheumatoid Arthritis. It's investigating a new treatment called Tyenne, given as an injection, to see how well it helps control these conditions. The main goal is to find out what percentage of people achieve a significant reduction in their disease activity – known as 'remission' – after 24 weeks. The study also wants to see if using Tyenne alongside existing treatments might work better than current approaches. Researchers will be looking at how safe the new treatment is and if it helps people feel better. This is an early-stage study, meaning it's one of the first steps to see if the treatment is promising.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cardiff University

Enrolment target

Start

30 Oct 2025

Psoriatic Arthritis Rheumatoid Arthritis

What is this study about?

This study is called 'DECISION ON OPTIMAL COMBINATORIAL THERAPIES IN IMMUNE-MEDIATED INFLAMMATORY DISEASES (IMIDS) USING SYSTEMS APPROACHES'. That's a bit of a mouthful, so let's break it down. It's looking at a new medicine called Tyenne for two specific conditions: Psoriatic Arthritis (PsA) and Rheumatoid Arthritis (RA). Both of these are 'immune-mediated inflammatory diseases,' which means your body's immune system mistakenly attacks healthy tissues, causing pain and swelling, especially in your joints.

The main aim of this research is to see if Tyenne can help people with PsA and RA achieve 'remission.' Remission means a significant reduction in the symptoms of your disease, where it's much less active or even stops causing problems. The study will look at how many people reach this point after 24 weeks of treatment. For people with RA, they'll use a score called CDAI, and for PsA, they'll use DAPSA to decide if someone is in remission.

Beyond just seeing if Tyenne works on its own, the study also wants to explore if combining Tyenne with other existing treatments might be even more effective at getting RA and PsA under control. It's also important to gather information on how safe Tyenne is and if people can tolerate it well. This kind of research is really important because it helps doctors find better ways to treat these long-term conditions and improve the quality of life for people living with them.

Key takeaways

Tests a new medicine, Tyenne, for Psoriatic Arthritis and Rheumatoid Arthritis.
Aims to see if Tyenne helps achieve 'remission' (reduced disease activity).
Explores if combining Tyenne with other treatments works better.
Will assess the safety and side effects of Tyenne.
Involves regular clinic visits and health checks over 24 weeks.

Who may be eligible?

This study is looking for adults who are at least 18 years old. People of any gender can take part.

To be considered for this study, you must have been diagnosed with either Psoriatic Arthritis (PsA) or Rheumatoid Arthritis (RA). The researchers will also check specific details about your current health and how your condition is affecting you to make sure the study is a good fit.

There might be other health checks or conditions that would prevent someone from joining, such as certain other illnesses or medications they are currently taking. These are in place to ensure the safety of everyone involved and that the study results are clear and accurate.

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 18 years old or older?
Do you have a diagnosis of Psoriatic Arthritis?
Do you have a diagnosis of Rheumatoid Arthritis?
Are you comfortable with receiving an injected medication?
Are you able to attend regular clinic appointments for about 24 weeks?

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 medication, Tyenne, which is given as an injection. You will likely have regular appointments at a clinic for check-ups over a period of 24 weeks. During these visits, doctors and nurses will assess your health, symptoms, and how well the treatment is working. This might involve physical examinations, blood tests, and filling out questionnaires about your symptoms and how you are feeling. The total duration of active treatment and assessments would be about 24 weeks, followed by some follow-up appointments.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as gaining access to a new treatment like Tyenne that isn't yet widely available, and receiving close medical attention. However, like all medicines, Tyenne might have side effects, and some effects of new treatments aren't fully known. There's also no guarantee that the treatment will work for you. 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.

—
Unverified
Spain

Common questions

What is Psoriatic Arthritis (PsA) and Rheumatoid Arthritis (RA)?

Both are long-term conditions where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness.

What is 'remission' in this study?

Remission means a significant reduction or even a complete stop in your disease symptoms and activity, as measured by specific medical scores.

What is Tyenne?

Tyenne is the name of the new medicine being tested in this study. It's given as an injection.

Is this a new type of treatment?

Yes, this study is exploring a new treatment strategy, including potentially combining Tyenne with other existing medicines.

How long would I be involved in the study?

The main treatment and assessment period for this study is 24 weeks, with some follow-up after that.