AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized, double blind, placebo-controlled, phase II, multicentre trial to explore the efficacy and safety of oral AP1189 tablets administered at the dose 100 mg/day for 12 weeks in patients diagnosed with polymyalgia rheumatica and in remission on glucocorticoid

This study is investigating a new medication called AP1189 for people living with polymyalgia rheumatica (PMR). If you have PMR and your symptoms are currently under control with steroid medication, this trial might be for you. Researchers are giving some participants the new AP1189 tablet (100 mg daily) and others a dummy tablet (placebo) for 12 weeks. The main goal is to check how safe AP1189 is and if it helps patients reduce or stop their steroid medication without their PMR returning. They will also look at how patients feel, their pain levels, and their general quality of life during the study. It's a 'blinded' study, meaning neither you nor your doctor will know if you're getting the new drug or the placebo.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Synact Pharma ApS

Enrolment target

Start

19 Mar 2026

Polymyalgia rheumatica

What is this study about?

This study is designed for people who have polymyalgia rheumatica (PMR) and are currently managing their condition well with steroid medication. PMR is a condition that causes muscle pain and stiffness, most often in the shoulders, neck, and hips. While steroids are effective, long-term use can have side effects. That's why researchers are looking for new treatments that might help people reduce their reliance on steroids.

The main aim of this study is to explore if a new tablet called AP1189 is safe and effective. Participants will take either the AP1189 tablet or a dummy tablet (known as a placebo) once a day for 12 weeks. Neither you nor your study doctor will know which tablet you are receiving, which helps make the study fair and unbiased. The researchers will closely monitor your health and how you feel throughout this period.

They want to find out if this new tablet can help people with PMR stay well and potentially even stop taking their steroid medication. They will also be looking at overall safety, your pain levels, how active your PMR is, and your general well-being and quality of life during the 12 weeks. This is a "Phase II" study, which means it's an early stage of testing a new drug to see if it works and what the best dose might be.

Key takeaways

Investigates a new tablet (AP1189) for PMR.
For adults with PMR whose symptoms are controlled by steroids.
Compares AP1189 to a dummy tablet (placebo) for 12 weeks.
Aims to check safety and if it helps reduce steroid use.
Includes regular health checks and monitoring.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.

You must have been diagnosed with polymyalgia rheumatica (PMR), and your symptoms should currently be under control with steroid medication. This means your PMR is in 'remission' because of the steroids you're taking.

There might be other specific health requirements for taking part that the study team will explain, as they need to make sure the study is safe for everyone involved.

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?
Have you been diagnosed with polymyalgia rheumatica (PMR)?
Are your PMR symptoms currently under control with steroid medication?
Are you able to attend regular study appointments for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given either the active study tablet (AP1189) or a dummy tablet (placebo) to take once a day for 12 weeks. You won't know which one you're taking, and neither will your doctor, to ensure fair results. The study medicines and the placebo will look identical.

Throughout the 12 weeks, you'll have several visits to the study clinic. During these visits, the study team will carry out physical check-ups, measure your vital signs like blood pressure, and take blood samples and other tests. They will also ask you questions about how you are feeling, your pain, and your overall health. This will help them monitor your safety and how the treatment is affecting your PMR. The total duration of your active involvement with the medication will be 12 weeks, with follow-up appointments planned after this period.

Potential risks and benefits

There are potential benefits to taking part in this study, such as receiving careful medical monitoring and contributing to research that could help others with PMR in the future. However, there are also potential risks, including possible side effects from the study medication, though these will be closely monitored. Since some participants will receive a placebo, it's possible you might not receive the active drug. You are completely free 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.

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Unverified
Denmark

Common questions

What is polymyalgia rheumatica (PMR)?

PMR is a condition causing muscle pain and stiffness, especially in the shoulders, neck, and hips.

What is a 'placebo'?

A placebo is a dummy tablet that looks exactly like the real medication but contains no active drug. It helps researchers understand the true effect of the new medicine.

Will I know if I'm getting the new drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know which tablet you are taking until the study is over.

How long will I take the study tablets?

You will take the study tablets once a day for 12 weeks.

What does a 'Phase II' study mean?

Phase II means it's an early stage of testing a new drug. Researchers are checking if it works, what the best dose might be, and its safety.