Not yet recruiting

A study to evaluate the safety and effectiveness of resomelagon in patients with polymyalgia rheumatica who are in remission using glucocorticoids

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Polymyalgia rheumatica, an inflammatory condition that causes muscle pain and stiffness, particularly in the shoulders and hips. The research involves patients who are currently in remission, meaning their symptoms are under control, while using glucocorticoid medication, which is a type of steroid used to reduce inflammation. The purpose of this study is to explore the safety and effectiveness of a new oral medication called AP1189, which contains the active substance resomelagon.

During the trial, participants will be assigned to receive either AP1189 tablets or a placebo. The study will last for a period of 12 weeks, during which the tablets will be taken once a day. This research aims to see if the new medication can help patients manage their condition and potentially reduce the need for steroid treatments.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Medication administration
The ap1189 tablet, which contains the substance resomelagon, is taken by mouth once every day at a dose of 100 mg for a total duration of 12 weeks.
Alternatively, a placebo tablet, which is identical in appearance to the test tablet but contains no active medicine, is taken once every day for 12 weeks.
Step 2
Safety and health monitoring
Throughout the 12-week period, physical examinations, measurements of vital signs (such as blood pressure and heart rate), and clinical laboratory testing (blood or urine tests) are performed to monitor health and safety.
Any adverse events, which are side effects or unintended medical occurrences, are monitored.
Step 3
Regular assessments
At week 4, week 8, and week 12, various assessments are conducted to evaluate the condition known as polymyalgia rheumatica (an inflammatory condition causing muscle pain and stiffness).
Assessments include measuring pmr activity scores and using several scales to evaluate fatigue, morning stiffness, and general well-being.
The duration of morning stiffness and the ability to perform daily activities are also recorded at these intervals.

Who can join the trial?

10 criteria

You must sign and date a consent form, which is a document that explains the study details and your agreement to participate, before any study activities begin.
You must be 50 years of age or older.
You must have been diagnosed with Polymyalgia rheumatica (an inflammatory condition that causes muscle pain and stiffness) following specific medical guidelines.
You must have started taking glucocorticoids (a type of steroid medicine used to reduce inflammation) for your condition at least 4 weeks before the start of the study.
You must be in clinical remission at the start of the study, meaning your symptoms are controlled and a blood test shows low levels of C-Reactive Protein (a marker in the blood that indicates inflammation).
Your C-Reactive Protein level must have been 8 mg/L or higher at the time you were first diagnosed.
You must not have Giant cell arteritis (an inflammation of the lining of your arteries), which will be checked using a vascular ultrasound (an imaging test that uses sound waves to look at blood vessels).
You must be willing and able to follow the study schedule, the treatment plan, and all required procedures.
Women who are able to become pregnant must have a negative pregnancy test during the screening process and again at the start of the study.
Women who can become pregnant and men who are sexually active must use a highly effective method of birth control (such as hormonal pills, an intrauterine device, or a vasectomy) during the study and for 90 days after the last dose, or they must choose to not have sex during that time.

Who cannot join the trial?

11 criteria

Having previously used glucocorticoids (a type of steroid medication used to reduce inflammation) to treat giant cell arteritis (a condition involving inflammation of the lining of your arteries).
Currently taking glucocorticoids (steroid medicine) by mouth, through a vein, or by injection to treat any condition other than polymyalgia rheumatica.
Having other types of inflammatory rheumatic diseases, which are conditions where the body's immune system attacks the joints or muscles, such as rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, or gout.
Having symptoms of giant cell arteritis, such as new headaches, pain when touching the temple area, jaw pain while eating, vision changes, or pain in the limbs when walking.
Having non-inflammatory joint or muscle conditions, such as osteoarthritis (wear and tear of the joints) or fibromyalgia (a condition causing widespread muscle pain), if these are severe enough to interfere with the study.
Having gastrointestinal diseases (problems with the stomach or intestines) that might change how the body absorbs or removes medicine.
Having severe or uncontrolled problems with the kidneys (including chronic kidney disease stage 4 or higher), liver, blood, stomach and intestines, metabolism, hormone system, lungs, heart, or nervous system.
Having had malignancy (cancer) in the last 5 years, except for certain types of skin cancer that have been treated or removed.
Having any other medical condition that the doctor believes could make the study unsafe or prevent the medicine from working correctly.
Being pregnant or currently breastfeeding.
Having taken part in another study involving an experimental drug within the last 4 weeks.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Odense University Hospital
Odense, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

AP1189 is an oral tablet being tested to see how well it works and how safe it is for people with polymyalgia rheumatica who are currently in remission using steroid medications.

Resomelagon

What is already known about the treatment

Resomelagon - This medication is an oral tablet taken once daily and is currently being studied in clinical trials to see if it can effectively treat polymyalgia rheumatica. It belongs to a class of drugs designed to manage inflammatory conditions by interfering with specific chemical signals in the body that cause swelling and pain. By targeting these molecules, the drug aims to help patients maintain remission without needing high doses of steroids.

Investigated diseases

Polymyalgia rheumatica - This condition is an inflammatory disorder that primarily affects the muscles around the shoulders and hips. It often causes significant stiffness and aching in these areas, particularly during the morning. The discomfort can make simple daily movements difficult to perform. Symptoms may fluctuate in intensity over time. The condition typically progresses through periods of increased activity followed by periods of relative calm.