All studies
Active not recruitingPHASE2INTERVENTIONAL

An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia

This research is an extension study for adult patients with sickle cell disease who have previously taken part in a study for a new medicine called IMR-687. The main goal of this particular study is to continue checking how safe IMR-687 is and how well people tolerate it when taken for a longer period. It's an "open-label" study, meaning both you and the study doctors will know you're receiving IMR-687. Researchers will also look at other effects of the medicine to understand it better. If you completed the previous IMR-687 study (called IMR-SCD-102), you might be able to join this one. It's designed to gather more important information about this potential treatment.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Imara, Inc.
Enrolment target
30
Start
22 May 2019
Estimated completion
01 Mar 2025

What is this study about?

Sickle cell disease is a lifelong condition that affects red blood cells. These cells, which are usually round, become C-shaped (like a sickle). This can cause pain, tiredness, and other serious health problems. Researchers are always looking for new and better ways to manage this condition and improve the lives of people living with it.

This study is about a medicine called IMR-687. It's not a new study of the medicine itself, but a continuation for people who have already been taking it in a previous research trial. The main reason for this extension study is to understand more about the long-term effects of IMR-687, especially its safety. When any new medicine is developed, it's very important to know if it's safe to take over many months or even years.

By taking part, you would be helping doctors and scientists learn more about IMR-687. This information is really important for deciding if this medicine could become a widely available treatment in the future. The more we know about how it works and how safe it is over time, the better decisions can be made about its use to help people with sickle cell disease.

Key takeaways

  • It's an extension study for an existing medicine called IMR-687.
  • Only adults (18+) who completed a specific previous study can join.
  • The main goal is to check the long-term safety of IMR-687.
  • You will know you are receiving the active medicine (open-label).
  • Participation involves taking the medicine and regular health checks.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. The most important requirement is that you must have already successfully completed a previous study for IMR-687, specifically the one known as "IMR-SCD-102." You also need to be able to understand what the study involves and agree to take part by signing a consent form.

There are also some health conditions that would prevent you from joining. For example, if you have certain levels of blood cells (like very high or very low red blood cell counts) or specific issues with your liver or kidneys, you might not be eligible. If you have active hepatitis B or C, active malaria, or HIV, you also wouldn't be able to participate. For women, you cannot be pregnant or breastfeeding, and you must agree not to become pregnant during the study. Men must also take steps to avoid getting a partner pregnant during the study.

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. Did you complete the earlier IMR-SCD-102 study?
  3. Are you able to understand and sign consent forms?
  4. Are you able to attend all study visits and appointments?
  5. Do you have a haemoglobin level within a certain range (not too high or too low)?
  6. Do you have healthy kidney and liver function?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would primarily be continuing to take the study medicine, IMR-687. You would have regular visits to the clinic where the study team would monitor your health. These visits would likely involve answering questions about how you're feeling, having your blood taken for tests, and possibly other physical checks. These checks are to make sure the medicine is not causing any problems and to see how your body is responding to it. The study team will explain the exact schedule of visits and what each visit will involve, including how long you would be expected to participate.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is continued access to IMR-687, which may help manage your sickle cell disease, and you will contribute to important medical research for others. However, like all medicines, IMR-687 may have side effects, and some may not be known yet, especially with long-term use. The study team will carefully monitor you for any reactions or changes in your health. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Connecticut Health Center
    Verified postcode
    Farmington, United States
  • Foundation for Sickle Cell Disease Research
    Verified postcode
    Hollywood, United States
  • Baylor Scott & White Medical Center - Temple
    Verified postcode
    Temple, United States
  • Bristol Haematology and Oncology Centre
    Verified postcode
    Bristol, United Kingdom
  • University College London Hospital NHS Foundation Trust
    Verified postcode
    London, United Kingdom
  • Guy's and St Thomas Hospital CRF
    Verified postcode
    London, United Kingdom
  • Royal London Hospital
    Verified postcode
    London, United Kingdom

Common questions

What is IMR-687?

IMR-687 is a new medicine being studied for adults with sickle cell disease. This study is looking at its long-term safety.

Who can join this study?

Adults (18+) who have already completed a previous study of IMR-687 (called IMR-SCD-102) and meet other health requirements can join.

What does 'open-label' mean?

It means both you and the doctors will know you are receiving the study medicine, IMR-687.

What will I have to do if I join?

You'll continue taking IMR-687 and attend regular clinic visits for health checks and blood tests.

Can I stop participating in the study if I want to?

Yes, you can leave the study at any time, for any reason, and it won't affect your medical care.

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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