Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis

This research study is investigating a new medication, Imvotamab, for individuals living with rheumatoid arthritis that is moderate to severe. It's an early-stage study, sometimes called a Phase 1b trial. The main goal at this point is to see if the new medicine is safe for people and what kind of effects it has on the body. This helps doctors learn more about Imvotamab before it moves on to larger studies. The study is open to adults aged 18 and over, regardless of whether they are male or female, and is focused on understanding this potential new treatment for a long-term condition that causes joint pain and swelling.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

IGM Biosciences Inc.

Enrolment target

Start

30 Nov 2023

Rheumatoid Arthritis

What is this study about?

Rheumatoid arthritis is a condition where your body's immune system mistakenly attacks your own joints, leading to pain, swelling, and stiffness. This study is testing a new medicine called Imvotamab. Think of it like exploring a new path – we need to go slowly and carefully to see where it leads.

Because this is a Phase 1b study, it means it's one of the first times this specific medicine is being given to people who have rheumatoid arthritis. The main aim is to check if it's safe and how the body handles it. Researchers will be looking for any side effects and how the medicine acts in the body. It's a crucial step in developing new treatments.

Understanding how a new medicine works and if it's safe is incredibly important for future patients. If this early study shows promising results, it might lead to bigger studies that further investigate if Imvotamab can help manage rheumatoid arthritis symptoms more effectively. This type of research helps medical science move forward in finding better ways to treat health conditions.

Key takeaways

Tests a new medicine (Imvotamab) for moderate to severe rheumatoid arthritis.
Focuses on safety and how the body handles the medicine (Phase 1b study).
Open to adults aged 18 and over, both men and women.
Participation involves regular clinic visits and monitoring.
Potential benefits include access to a new treatment, but risks include unknown side effects.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and older who have moderate to severe rheumatoid arthritis. Both men and women are welcome to take part.

To be considered for this study, you would need to have received a diagnosis of rheumatoid arthritis from a doctor and your condition would need to be in the moderate to severe category. This means your rheumatoid arthritis symptoms are significant and affect your daily life.

There might be other specific health requirements or conditions that would make someone either suitable or unsuitable for the study. These details would be discussed fully with you by the research team if you are interested.

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?
Is your rheumatoid arthritis considered moderate to severe?
Are you able to attend regular appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, Imvotamab. You would need to attend several appointments at the study clinic or hospital. These visits would involve regular check-ups, blood tests, and perhaps other assessments to monitor your health and how the medicine is affecting you. The doctors and nurses would keep a close eye on you to make sure you are safe and to record any changes. Details about the exact number of visits, their duration, and the total length of the study would be fully explained by the research team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of receiving a new treatment for your rheumatoid arthritis, which could help your symptoms, although this is not guaranteed as it's an early-stage study. However, there are potential risks, as with any new medicine. You might experience side effects that are currently unknown or different from existing treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What does 'Phase 1b' mean?

It means this is one of the first times this new medicine is being tested in people who have rheumatoid arthritis. The main goal is to check its safety and how it works in the body.

Is this medicine available to everyone?

No, Imvotamab is a new medicine still being tested. It's only available to people who join this specific research study.

What is rheumatoid arthritis?

It's a long-term condition where your body's immune system attacks your joints, causing pain, swelling, and stiffness.

Will I get better if I join this study?

We don't know yet. This study is mainly to see if the medicine is safe. While it might help, there's no guarantee that your symptoms will improve.

Do I have to pay to be in the study?

No, you should not have to pay for the study medication or study-related tests and appointments.