All studies
Active not recruitingPHASE2INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

This research study is looking into a new medication called Afimetoran for individuals living with active Systemic Lupus Erythematosus (SLE), often just called lupus. The main goal is to find out if Afimetoran is effective in treating lupus symptoms, how safe it is to use, and if people find it manageable. Participants will either receive Afimetoran or a placebo (a dummy pill with no active medicine). There's also an extension period where those initially on the placebo will get the chance to try Afimetoran. This longer period helps gather more information on safety and how well the medicine works over time.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Bristol-Myers Squibb
Enrolment target
268
Start
11 Oct 2021
Estimated completion
22 Apr 2029

What is this study about?

This study is about exploring a new treatment option called Afimetoran for Systemic Lupus Erythematosus (SLE), also widely known as lupus. Lupus is a long-term condition where the body's immune system mistakenly attacks its own tissues and organs. This can lead to a variety of symptoms, including joint pain, rashes, and tiredness.

The main purpose of this research is to understand if Afimetoran can help improve the symptoms of active lupus. The researchers also want to carefully check for any side effects and see if people tolerate the medicine well. To do this, some participants will receive Afimetoran, while others will be given a placebo, which looks like the real medicine but contains no active ingredients. This comparison helps scientists determine if any observed effects are truly due to the study medicine or something else.

After the main part of the study, there's usually an extended period. This means that participants who were initially given the placebo will then have the opportunity to take Afimetoran. This longer period is really important for collecting more information on the medicine's safety and how well it works over a longer term, which helps us understand its full potential.

Key takeaways

  • This study is testing a new medicine (Afimetoran) for lupus.
  • It aims to see how well it works, if it's safe, and if patients tolerate it.
  • Participants will get either Afimetoran or a placebo (dummy pill).
  • Close medical monitoring is provided throughout the study.
  • You might get access to a new treatment and help advance lupus research.

Who may be eligible?

To be part of this study, you would generally need to be between 18 and 70 years old. You must have been diagnosed with lupus at least 12 weeks before checking your suitability for the study, and your diagnosis needs to meet specific criteria for lupus.

You would also need to have positive results for certain blood tests related to lupus, which show that your immune system is overactive. Additionally, your lupus symptoms should currently be active, particularly affecting your joints or causing skin rashes. This activity will be measured using a specific scoring system.

However, some conditions would mean you couldn't join. For example, if you have severe kidney problems caused by lupus, or active severe brain or nerve problems from lupus, you wouldn't be eligible. Also, if you have another condition called Mixed Connective Tissue Disease where lupus isn't the main problem, or a condition called Antiphospholipid Syndrome, you wouldn't be able to participate. The study team will check other specific rules too.

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.

  1. Are you between 18 and 70 years old?
  2. Have you been diagnosed with lupus for at least 3 months?
  3. Do you have active lupus symptoms, especially joint pain or rashes?
  4. Do you *not* have severe kidney or brain/nerve problems related to lupus?
  5. Do you *not* have Antiphospholipid Syndrome or another primary related condition?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medicine, Afimetoran, or a placebo (a dummy pill). You wouldn't know which one you're getting, and neither would your study doctor, until the end of that part of the study. You would need to attend regular appointments at the study clinic. These visits would include physical examinations, blood and urine tests, and answering questions about your health and any symptoms you're experiencing. You would also need to take the study medication as instructed. The total time you'd be involved in the study and receiving treatment would be explained to you in detail by the study team.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. You would also contribute to scientific knowledge that could help others with lupus in the future. However, there are potential risks, like experiencing side effects from the investigational medicine, which may be mild or more serious. There's also no guarantee that the treatment will work for you, or that you'll receive the active drug rather than a placebo initially. Your involvement is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (147)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Local Institution - 0100
    Verified postcode
    Birmingham, United States
  • Local Institution - 0123
    Verified postcode
    Huntington Beach, United States
  • Local Institution - 0170
    Verified postcode
    La Jolla, United States
  • Local Institution - 0159
    Verified postcode
    La Palma, United States
  • Local Institution - 0172
    Verified postcode
    San Diego, United States
  • Local Institution - 0164
    Verified postcode
    Woodland Hills, United States
  • Local Institution - 0121
    Verified postcode
    Clearwater, United States
  • Local Institution - 0167
    Verified postcode
    Kissimmee, United States
  • Local Institution - 0122
    Verified postcode
    Orlando, United States
  • Local Institution - 0173
    Verified postcode
    Ormond Beach, United States
  • Local Institution - 0154
    Verified postcode
    Plantation, United States
  • Local Institution - 0137
    Verified postcode
    South Miami, United States

Common questions

What is Afimetoran?

Afimetoran is a new medicine being tested to treat active Systemic Lupus Erythematosus (lupus).

What is a placebo?

A placebo is a dummy pill that looks like the real medicine but contains no active ingredients. It's used to compare against the new medicine.

Will I know if I'm getting the real medicine or the placebo?

No, you and your study doctor won't know which you are receiving during the initial part of the study. This helps ensure the results are fair.

How long will the study last?

The study involves a main treatment period and an optional extension period. The total duration will be discussed with you by the study team.

Can I leave the study at any time?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.