Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Isatuximab in type I cryoglobulinemia: A prospective pilot study / ICE STUDY

This study is investigating a new medication, Isatuximab, for individuals living with type I cryoglobulinemia. This condition causes blood vessels to become inflamed, leading to various symptoms. The main goal of this early-stage study is to find out how effectively Isatuximab can reduce these symptoms of blood vessel inflammation within 20 weeks. Researchers will also be checking for any side effects to understand how safe the medicine is. They will look at how well the cryoglobulin levels clear up, how kidney function improves, and how the patient's general well-being and quality of life change over time. Participants in the study will be adults, and both men and women can join.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

29 Nov 2024

Isatuximab in type I cryoglobulinaemia: A prospective pilot study

What is this study about?

This research, called the ICE study, is looking into a new medicine named Isatuximab for people who have type I cryoglobulinemia. This is a condition where certain proteins in your blood (called cryoglobulins) clump together, especially in cooler temperatures. These clumps can block small blood vessels and cause inflammation, leading to a range of symptoms and affecting different parts of your body, including your skin, nerves, and kidneys.

The main aim of this study is to see how well Isatuximab can help improve the symptoms of this blood vessel inflammation, specifically by twenty weeks after starting treatment. This is considered an 'exploratory' or 'Phase II' study, which means it's an early step in testing a new medicine to find out if it works and what the right dose might be, as well as to check for safety.

Besides looking at symptom improvement, the study will also carefully monitor any side effects to make sure the medicine is well-tolerated. Researchers will also check other important things like how well the cryoglobulins clear from the blood, whether kidney problems improve, and how the medicine affects a person's overall quality of life. Understanding all these factors will help doctors decide if Isatuximab could be a helpful treatment for type I cryoglobulinemia in the future.

Key takeaways

This is an early-stage study (Phase II) testing a new medicine called Isatuximab.
It's for people with type I cryoglobulinemia, a rare condition causing blood vessel inflammation.
The study aims to see if Isatuximab can reduce symptoms and if it's safe.
Both men and women aged 18 and over can participate.
You'll have regular check-ups and will be followed for up to 48 weeks.

Who may be eligible?

To be able to join this study, everyone who participates must be an adult, aged 18 or older. There is no upper age limit, meaning older adults can also be considered.

Both men and women are welcome to take part in this research study, ensuring that we understand how the treatment works across different people. The study team will review your medical history and current health to make sure that taking part is safe and appropriate for you.

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?
Do you have a diagnosis of type I cryoglobulinemia?
Are you able to attend regular clinic appointments?
Are you willing to potentially receive a new, unproven medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, Isatuximab. You will have regular visits to the clinic for check-ups and assessments, which will include blood tests to measure your cryoglobulin levels and kidney function, as well as physical examinations to monitor your symptoms.

These visits will happen at specific times, including at weeks 4, 12, and 20. There will also be follow-up observations for a longer period, up to 48 weeks, to see how you are doing over time and to check for any long-term effects or if symptoms return. You will also be asked to complete questionnaires about your quality of life.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that might help your condition, potentially reducing your symptoms and improving your health. However, like all medicines, Isatuximab might have side effects, which the study team will monitor closely. There might also be unknown risks, as it is a new treatment. You can stop participating in 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
France

Common questions

What is type I cryoglobulinemia?

It's a rare condition where certain blood proteins can clump together, especially in cooler temperatures, causing inflammation in blood vessels and various symptoms.

What is Isatuximab?

Isatuximab is the new medicine being tested in this study to see if it can help treat type I cryoglobulinemia.

How long will the study last?

The main treatment period for assessing symptoms is 20 weeks, but you'll be followed up for a total of 48 weeks to see how you do over time.

What is the main goal of the study?

The main goal is to see how well Isatuximab can reduce the symptoms of blood vessel inflammation (vasculitis) by 20 weeks and to check its safety.

Will I have to pay anything to be in the study?

No, participating in clinical studies like this is typically free of charge, and costs related to the study medication and visits are covered by the research team.