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(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

Join a study comparing CGT9486 with placebo for systemic mastocytosis.

Recruiting
18 years and older
All
Phase 2

This study is testing a new medicine called **bezuclastinib (CGT9486)** for people with a condition called systemic mastocytosis (SM). This condition is where certain immune cells, called mast cells, build up in the body. The study compares bezuclastinib with a placebo (a pill with no medicine) to see which works better. It's for people whose symptoms are not controlled well by their current care. The study has three parts. In the first parts, patients will get either bezuclastinib or a placebo. In the last part, everyone can try bezuclastinib. To join, you need to have a specific type of SM, like indolent or smoldering SM, and have moderate to severe symptoms. People with advanced types of SM or other serious conditions can't join. Also, if you've had certain treatments recently, you might not be eligible.

  • **Length**: The study has multiple parts, and participation may extend over several weeks or months.
  • **Visits**: Participants will need to visit study locations for assessments and treatments.
  • **Treatment**: You may receive bezuclastinib or a placebo, depending on the study part.
Study details
    SSM
    Mastocytosis
    Indolent
    Mastocytosis
    Systemic
    Mastocytosis
    ISM
    BMM
    Smoldering Systemic Mastocytosis
    Bone Marrow Mastocytosis

NCT05186753

Cogent Biosciences, Inc.

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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