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ANUMIGILIMAB

Clinical trials are studying ANUMIGILIMAB in adults with sickle cell disease. The main goal is to check safety and look for signs of benefit in this patient group. The trial data below describes who can take part, what is being measured, and the study phase.

Table of Contents

Trial overview

The available trial is Phase 2 and is studying ANUMIGILIMAB in adults with sickle cell disease.[1]

This is an interventional study, which means researchers are giving a study treatment and then watching what happens.[1]

The brief study summary says the main objective is to assess the safety of ANUMIGILIMAB in adults with sickle cell disease.[1]

Who can participate

The target population for this study is adults with sickle cell disease.[1]

The source data does not list more detailed eligibility rules, such as age limits beyond adulthood or other health conditions that may affect joining the trial.

What is being measured

The main outcome is the number and percentage of participants with treatment-emergent adverse events, also called TEAEs.[1]

These are health problems that start after the study treatment begins, or get worse during the study.[1]

Researchers also measure adverse events of special interest, or AESIs, which are side effects that need extra attention in the study.[1]

Another endpoint is clinically relevant changes from baseline in laboratory assessments and vital signs.[1]

“Baseline” means the starting point before the study treatment is given.[1]

Vital signs include basic body checks such as blood pressure and pulse, while laboratory assessments are tests of blood or other samples.[1]

Study design and treatment groups

The study lists ANUMIGILIMAB given as a subcutaneous treatment, which means under the skin.[1]

The trial also lists saline 0.9% as a comparison treatment.[1]

This comparison helps researchers look at results in a group that does not receive the study drug in the same way.[1]

Trial status and size

The study status is Authorised.[1]

The planned enrollment is 63 participants, meaning the study aims to include 63 people.[1]

At this stage, the main focus is on understanding safety in the target group rather than proving long-term benefit.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07224360 Phase 2 Sickle Cell Disease Authorised 63

FAQ

  • What is being studied in ANUMIGILIMAB trials? The trial is studying ANUMIGILIMAB in adults with sickle cell disease. The main focus is safety, including side effects and changes in lab tests and vital signs.
  • Who can participate in the ANUMIGILIMAB trial? The trial is for adults with sickle cell disease. The source data does not give more details about other eligibility rules.
  • What phase is the ANUMIGILIMAB study? This study is in Phase 2. Phase 2 trials usually look more closely at safety and early signs of benefit in a specific patient group.
  • What outcomes are measured in the trial? The study measures treatment-emergent adverse events, adverse events of special interest, and clinically relevant changes in laboratory tests and vital signs. These results help researchers understand how the study treatment affects participants.
  • How many people are planned for the ANUMIGILIMAB study? The planned enrollment is 63 people. This is the number of participants the study aims to include.

Ongoing Clinical Trials on ANUMIGILIMAB

  • A study to assess the safety of Anumigilimab in adults with sickle cell disease

    Not yet recruiting

    2 1
    Investigated drugs:
    Belgium France Italy The Netherlands

Glossary

  • Sickle cell disease: A blood disorder that can cause red blood cells to become stiff and shaped like a sickle, or crescent. This can lead to pain and other health problems.
  • Phase 2: A stage of clinical research that usually looks at safety and early signs that a treatment may help a certain group of patients.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Subcutaneous: Given under the skin.
  • Saline 0.9%: A saltwater solution that is often used as a comparison treatment in studies.
  • Treatment-emergent adverse events: Health problems that start or get worse after a person begins the study treatment.
  • Adverse events of special interest: Side effects that researchers watch very carefully because they may be especially important for the study.
  • Laboratory assessments: Tests done on blood or other samples to check how the body is working.
  • Vital signs: Basic body measurements such as blood pressure, pulse, temperature, and breathing rate.
  • Enrollment: The number of people a study plans to include.

References