This study is evaluating the safety and effectiveness of an investigational medicine in people with primary immune thrombocytopenia (ITP).  By choosing to volunteer, you will represent many others like you who are living with primary ITP.

Who may participate

Joining a research study is an important and personal decision. Thank you for considering this study.

This study may be an option for you if you are between the ages of 18 – 70 and were diagnosed with primary ITP at least 3 months ago.

There are other requirements for participation in the study. The study doctor will explain these to you.

Conditions

Primary Immune Thrombocytopenia

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Age

18 - 70 years

The age a person must be to participate in a clinical trial.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

If you decide to participate, the study team will conduct a screening visit to determine if you meet the study requirements.

All participants will receive the study medicine during their time in the study. The study medicine is given as a subcutaneous injection (beneath the skin) in the abdomen, arm, or thigh once a month for 3 months.

You will be enrolled in the study for a minimum of 5 months. During this time, you will need to attend at least 9 office visits so the study team can monitor how you are responding to the study medicine. The study team will perform physical exams and other tests to monitor your health. If your B cell counts have not improved after 5 months, you will be asked to attend additional follow-up visits about every 2 months until they do.

Length of study treatment

3 months

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

9

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

2 follow-up visits at Week 16 and Week 20.

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

Additional medications

Prednisone, diphenhydramine, acetaminophen

Additional medications will be given before and after each dose of the study medicine. These medications are given to prevent an injection reaction to the study medicine and are not being studied as part of this clinical trial.

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Frequently Asked Questions

How long will I be in this study?

You should expect to be in the study for a minimum of 5 months.  

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Will I know if I’m receiving the study medicine?

This study does not include a placebo, meaning all participants will receive the study medicine.

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What if I change my mind about participating?

Your participation in this study is completely optional. You can choose to stop participating in the study at any time, for any reason. Choosing not to participate in this study will not affect your future medical care.  

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What are possible side effects?

Your study doctor will discuss all the possible risks and benefits of participating in this study with you before you choose to enroll. You can choose to no longer participate in the study at any time.

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What about COVID-19?

Because the study medicine may interfere with COVID-19 vaccines, if you should require this vaccine, you should complete your final vaccination dose at least 1 month before starting the study. You will not be able to get a COVID-19 vaccine during your time in the study. You should let the study team know right away if you are diagnosed with COVID-19 or have any signs or symptoms of COVID-19 during your time in the study.

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