Now enrolling: a clinical trial to develop a possible treatment for primary Immune Thrombocytopenia (ITP).
This study is evaluating an investigational medicine for people with primary immune thrombocytopenia (ITP). Participants will receive care from a dedicated team of healthcare professionals throughout the clinical trial.
Who may participate
Joining a clinical trial is an important and personal decision. Thank you for considering this trial.
This trial 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.
Many factors, including genetics, race, ethnicity, and sex, can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
There are other requirements for participation in the study. The study doctor will explain these to you.
Condition
Primary Immune Thrombocytopenia
Age
18-70 years
Sex
Male or Female
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.
Additional eligibility criteria
Additional inclusion and exclusion criteria will be reviewed during the first contact with the site team.
What to expect
If you decide to participate, the trial team will conduct a screening visit to determine if you meet the trial requirements.
Unlike some clinical trials, this trial does not have a placebo group and all participants will receive the medicine being studied during their time in the trial. The study medicine is given as an injection just beneath the skin in the abdomen, arm, or thigh, once a month for 4 months.
You will be enrolled in the trial for a minimum of 7 months. During this time, you will attend visits on average every 2 weeks so the trial team can monitor how you are responding to the study medicine. The trial team will perform physical exams and other tests to monitor your health.
Length of study treatment
4 months
Number of study visits
11 visits
Long-term follow up
2 follow-up visits at Week 20 and Week 24
Additional medications
Prednisone, diphenhydramine, acetaminophen
About Primary Immune Thrombocytopenia
Immune thrombocytopenia (ITP) is an autoimmune disorder in which the immune system mistakenly attacks healthy platelets (cells that help blood clot). In some cases, ITP is caused by the body’s response to another disease or infection, but in other cases, doctors are not sure what causes ITP. When someone develops ITP without a clear reason, it is called primary ITP.
Some people with ITP may not have any symptoms, but others may experience easy or excessive bruising and bleeding. Current treatments for ITP include corticosteroids like prednisone or dexamethasone, and in severe cases, transfusion or surgery.
About the Study Medicine
The study medicine is an investigational biologic (a type of drug), given as four injections in the abdomen, arm, or thigh. It is currently in development for the treatment of lupus. Researchers believe it may also be helpful for treating other autoimmune diseases like primary ITP.
The study medicine is considered investigational because it has not yet been approved for use outside of clinical trials.
Frequently Asked Questions
You should expect to be in the study for a minimum of 7 months.
This study does not include a placebo (a placebo does not have any medicine in it but looks just like the medicine being studied), meaning all participants will receive the study medicine.
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.
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.
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.
