Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.

This study is investigating a new oral medicine called AP1189 for adults with rheumatoid arthritis who have recently been diagnosed and haven't yet used certain types of powerful arthritis drugs. The main goal is to find out if AP1189, when taken alongside a standard medicine called methotrexate, helps reduce arthritis symptoms and inflammation over 12 weeks. Researchers will explore three different doses of AP1189 – 40mg, 70mg, and 100mg – to see which one works best and is safe. The study will compare AP1189 to a dummy pill (placebo) to truly understand its effects. This is an important step to see if AP1189 could become a new treatment option for rheumatoid arthritis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Synact Pharma ApS

Enrolment target

172

Start

18 Nov 2024

Rheumatoid Arthritis

What is this study about?

This study is a clinical trial looking into a potential new treatment for rheumatoid arthritis, a condition that causes pain, swelling, and stiffness in the joints. The new medicine being tested is called AP1189, which is given as a tablet. The trial is designed for people who have been diagnosed with rheumatoid arthritis fairly recently and haven't yet started on other strong arthritis medicines, often referred to as 'DMARDs'. Participants will take AP1189, or a dummy pill, alongside methotrexate, which is a common and effective medicine for rheumatoid arthritis.

The main purpose of this study is to see how well different doses of AP1189 (40mg, 70mg, or 100mg) work to reduce the signs and symptoms of rheumatoid arthritis over 12 weeks. Researchers will be carefully checking how much the inflammation in your joints improves. They will also be looking at the safety of AP1189 and how well people tolerate it at these different dose levels. By comparing AP1189 to a dummy pill (placebo), the study aims to understand the true impact of the new medicine.

This is a 'Phase II' study, which means it's an early stage of testing. If AP1189 shows promising results in terms of effectiveness and safety in this trial, it could move on to larger studies. The ultimate goal is to find new and better ways to manage rheumatoid arthritis, which could potentially improve the lives of many people living with this condition.

Key takeaways

This study is testing a new tablet medicine, AP1189, for rheumatoid arthritis.
It's for adults recently diagnosed with rheumatoid arthritis who haven't used certain strong arthritis drugs.
Participants will also take methotrexate, a standard arthritis medicine.
The study will look at different doses of AP1189 over 12 weeks to see how safe and effective they are.
You will be randomly assigned to receive AP1189 or a dummy pill.
Close medical monitoring and regular clinic visits are part of participation.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. It doesn't matter if you are male or female.

The study is specifically looking for people who have been diagnosed with rheumatoid arthritis. Crucially, you must be new to certain types of strong medicines for arthritis, meaning you haven't taken them before. This helps the researchers understand the effect of the new medicine without other strong drugs interfering.

There will be other detailed medical checks to make sure the study is right and safe for you. These will be discussed fully by the study team, but generally involve your overall health and the specifics of your rheumatoid arthritis.

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 rheumatoid arthritis?
Have you NOT taken powerful arthritis medicines (DMARDs) before?
Are you able to attend regular clinic appointments for 12 weeks and beyond?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned by chance (like flipping a coin) into one of several groups. Some groups will receive different doses of the new medicine, AP1189, while others will receive a dummy pill (placebo). Everyone in the study will also take methotrexate, a standard arthritis medicine. You won't know which group you are in, and neither will your study doctor, to keep the results fair.

Over 12 weeks, you would have several visits to the clinic for assessments. These visits would involve physical examinations, blood tests, and answering questionnaires about your pain, daily activities, and how you are feeling. Doctors will also count your tender and swollen joints. After the main 12-week treatment period, there will likely be follow-up appointments to monitor your health.

Taking part in the study means you'd be committing to regular clinic visits, taking your study medication as instructed, and providing honest feedback about your symptoms. The total duration of active treatment in the study is 12 weeks, with additional follow-up appointments.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment before it's widely available, and you would receive very close medical monitoring of your condition. However, there are potential risks, such as side effects from the study medication or the possibility that the new medicine might not help your condition, or that you receive the dummy pill. Like all medicines, AP1189 may have side effects, and some may not be known yet. You will be fully informed of all known risks before you make a decision, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Bulgaria
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Unverified
Czechia
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Unverified
Poland
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Unverified
Romania
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Unverified
Denmark

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition where your body's immune system mistakenly attacks your joints, leading to pain, swelling, and stiffness.

What is AP1189?

AP1189 is a new medicine being tested in tablet form. Researchers are trying to find out if it can help reduce inflammation and symptoms in people with rheumatoid arthritis.

Why is this called a 'Phase II' study?

Phase II means it's an early stage of testing. It's designed to see if the medicine works, find a good dose, and check for side effects, before moving to bigger studies.

What is 'placebo'?

A placebo is an inactive dummy pill that looks just like the study medicine. It helps researchers compare the real drug's effects to what happens naturally or from the expectation of treatment.

Will I still take my regular arthritis medicines?

If you join this study, everyone will be taking methotrexate, a common arthritis medicine, alongside either AP1189 or the dummy pill. Your study doctor will advise on any other medicines.