All studies
Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis

This research is looking into a new medicine called IMVT-1402 for adults who have rheumatoid arthritis (RA). Specifically, it's for those whose RA is active, difficult to treat, and has a particular marker in their blood. The study aims to see how well IMVT-1402 works and if it's safe, by comparing it to a placebo (a dummy treatment). Participants won't know if they are getting the new medicine or the placebo. This study is important for finding new ways to manage RA for people who haven't responded well to other treatments, potentially improving their symptoms and quality of life.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Immunovant Sciences GmbH
Enrolment target
120
Start
10 Jan 2025
Estimated completion
01 Sep 2027

What is this study about?

If you have rheumatoid arthritis (RA) that hasn't responded well to your usual treatments, you might be interested in this research study. It's looking into a new medication called IMVT-1402. The main goal is to find out if this medicine can help improve the symptoms of RA and if it's safe for people to use.

Rheumatoid arthritis is a condition where your body's immune system mistakenly attacks your own joints, causing pain, swelling, and stiffness. For some people, existing medicines don't fully control their RA, leading to ongoing discomfort and difficulty with daily activities. This study focuses on adults with this 'difficult-to-treat' type of RA.

By taking part, you would be helping doctors and researchers understand if IMVT-1402 could be a valuable new option for people struggling with their RA. The study carefully compares the new medicine to a placebo, which looks identical but has no active drug, to ensure any effects observed are truly due to IMVT-1402. This scientific approach helps us learn if it's an effective and safe treatment.

Key takeaways

  • This study evaluates a new treatment, IMVT-1402, for difficult-to-treat rheumatoid arthritis.
  • It aims to find out if the medicine is safe and effective compared to a placebo.
  • Participants will receive the study drug or a dummy treatment for different periods.
  • The study could last up to 86 weeks with regular check-ups.
  • It's for adults whose RA hasn't responded to at least two previous strong medications.

Who may be eligible?

This study is looking for adults aged 18 or over. You would need to have been diagnosed with rheumatoid arthritis using specific criteria, and your RA should still be active with a certain number of tender and swollen joints, and markers in your blood.

Crucially, your RA must have proven difficult to treat, meaning that at least two previous types of powerful RA medications haven't worked well enough for you. You also need to have a specific type of antibody in your blood called ACPA.

There are also some reasons why you might not be able to join. For example, if you've recently had certain other treatments, have other specific inflammatory joint conditions, a history of certain cancers, or problems with your immune system, this study might not be right for you. Your doctor will check all these details carefully.

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 18 years old or older?
  2. Have you been diagnosed with rheumatoid arthritis?
  3. Do you have active RA symptoms (tender and swollen joints)?
  4. Have at least two strong RA medications not worked well enough for you?
  5. Do you have high levels of certain immune markers (ACPA and IgG) in your blood?
  6. Have you discussed your full medical history with your doctor regarding this study?
Answer every question to see your result.

What does participation involve?

If you join this study, it could last up to 86 weeks, which is about a year and a half. For the first 16 weeks, everyone will receive the study medicine openly. After that, for 12 weeks, you'll be randomly given either the study medicine or a placebo (a dummy treatment), and you won't know which one you're getting. There's also an optional additional period of up to 48 weeks where you might continue receiving the study medicine.

Throughout the study, you'll have regular visits to the clinic for check-ups. These visits will involve various assessments, including checking your joints, blood tests, and discussing your symptoms and how you're feeling. The team will explain exactly what's involved at each visit and answer any questions you have.

Potential risks and benefits

Taking part in a study like this might offer the chance to try a new medicine that could help your rheumatoid arthritis if other treatments haven't worked. However, there's no guarantee the new medicine will help you, and you might experience side effects, just like with any medicine. Since some participants will receive a placebo, your RA might not improve during that part of the study. All potential risks and side effects will be fully explained before you decide to join. Remember, taking part is completely voluntary, and you can withdraw from the study at any time without affecting your usual medical care.

Locations (83)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Site Number - 1018
    Verified postcode
    Mesa, United States
  • Site Number - 1019
    Verified postcode
    Sun City, United States
  • Site Number - 1022
    Verified postcode
    Covina, United States
  • Site Number - 1028
    Verified postcode
    San Leandro, United States
  • Site Number - 1024
    Verified postcode
    Temecula, United States
  • Site Number - 1033
    Verified postcode
    Tujunga, United States
  • Site Number - 1023
    Verified postcode
    Whittier, United States
  • Site Number - 1020
    Verified postcode
    Denver, United States
  • Site Number - 1015
    Verified postcode
    Jupiter, United States
  • Site Number - 1002
    Verified postcode
    Miami, United States
  • Site Number - 1027
    Verified postcode
    Plantation, United States
  • Site Number - 1005
    Verified postcode
    Winter Park, United States

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis (RA) is a long-term condition where your body's immune system attacks your joints, causing pain, swelling, and stiffness, often affecting your hands and feet.

What does 'difficult-to-treat' mean?

It means your rheumatoid arthritis hasn't responded well enough to at least two standard, powerful RA medications, and you continue to have active symptoms.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is having an effect.

How long will I be in the study?

Your total time in the study could be up to 86 weeks, which is about a year and a half. This includes different phases of treatment and monitoring.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your regular medical care. Your decision is always respected.

How to find out more

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

Discussion

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