Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus

This research trial is investigating a new medication, MK-6194, for adults who have Systemic Lupus Erythematosus, often just called lupus. The main goal is to find out if MK-6194 can improve lupus symptoms better than a dummy treatment (placebo). Researchers will also be carefully checking for any side effects to make sure the medicine is safe. Participants will be randomly assigned to receive either the new medicine or the placebo. This type of study helps doctors understand how well new treatments work and if they are safe for people with lupus. The study will look at how many people feel better after 28 weeks and also over a longer period up to 52 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

26 Feb 2024

Systemic Lupus Erythematosus

What is this study about?

This study is a clinical trial, which means it's a carefully planned research project to test a new medicine or treatment. In this case, the new medicine is called MK-6194, and it's being tested for adults diagnosed with Systemic Lupus Erythematosus, or SLE — a condition where your body's immune system mistakenly attacks its own tissues and organs. The trial is designed to see if MK-6194 is both effective in managing lupus symptoms and safe for people to use.

To make sure the results are fair and accurate, some participants will receive MK-6194, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active ingredients – it's like a dummy pill. Neither the participants nor the doctors will know who is getting which treatment. This method helps to avoid any bias and ensures that any improvements seen are genuinely due to the new medicine and not other factors, like the expectation of feeling better.

The researchers will be looking closely at several things. A key question is how many people taking MK-6194 show a significant improvement in their lupus symptoms after 28 weeks, and again at 52 weeks, compared to those taking the placebo. They'll also be tracking any side effects carefully. This will help them understand the benefits and any potential risks of the new medicine. Other measurements include how it affects joint pain, skin rashes seen in lupus, and whether participants can reduce their steroid medication doses, which can have side effects over time. All this information is important to decide if MK-6194 could be a helpful new treatment option for lupus.

Key takeaways

This study is testing a new medicine (MK-6194) for adults with lupus.
It aims to see if the new medicine improves lupus symptoms and is safe.
Some participants will get the new medicine, others a dummy medicine (placebo).
Neither you nor your doctor will know which treatment you are getting.
Your health and lupus symptoms will be closely watched over 28 to 52 weeks.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

There might be other specific health requirements or conditions that would mean you can or cannot take part. These details are important to make sure the study is safe for everyone involved and that the results are clear.

If you're interested, the study doctors will go through all the detailed requirements with you. They will check your medical history to see if this study is the right fit for your health situation.

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 Systemic Lupus Erythematosus?
Are you comfortable with the idea of taking either a new medicine or a placebo?
Are you able to attend regular study appointments?
Do you understand you can leave the study at any time?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full health check-up to make sure you meet all the requirements. Once confirmed, you would be randomly assigned to receive either the new medicine, MK-6194, or a placebo (a dummy medicine).

During the study, you would need to attend regular appointments at the study clinic. At these visits, doctors and nurses will monitor your health, check your lupus symptoms, and look for any side effects. They might perform examinations, take blood or urine samples, and ask you specific questions about how you're feeling. They'll also track any changes in your medication, such as steroid doses.

The study treatment will last for a period, with initial results being checked at 28 weeks and further monitoring up to 52 weeks. It's important to keep all your appointments and follow the study instructions carefully. You will have a chance to ask any questions you have throughout the process.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as gaining access to a new treatment before it's widely available, and receiving close medical attention for your lupus. However, there are also potential risks; the new medicine might cause side effects, some of which could be serious, or it might not work as well as expected. The placebo also means you might not receive an active treatment for your lupus during the study period. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
France
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Unverified
Spain
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Unverified
Poland
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Unverified
Italy

Common questions

What is Systemic Lupus Erythematosus (SLE)?

SLE, or lupus, is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues, which can affect many different parts of the body, including joints, skin, and organs.

What is a 'placebo'?

A placebo is a dummy treatment. It looks like the real medicine but contains no active ingredients. It's used in studies to compare against the new medicine so researchers can see if the new medicine really works.

What does 'randomized' mean in a study?

Being 'randomized' means you'll be put into a treatment group (either receiving the new medicine or the placebo) by chance, like flipping a coin. No one chooses which group you're in.

What does 'double-blind' mean?

In a 'double-blind' study, neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This helps prevent bias in the results.

How long will I be in the study?

The study will involve monitoring your health and treatment effects, with key results looked at after 28 weeks, and continued observations up to 52 weeks.