Tired of the ups and downs of

Immune Thrombocytopenia (ITP)?

Join a clinical research study aiming to increase platelets in adults whose counts have gone up with initial therapy but then have gone down.

The goal of the research is to investigate the safety and efficacy of an investigational study drug designed to treat ITP

About mezagitamab
(TAK-079), the investigational study drug

The purpose of this study is to find out how well the investigational study drug (mezagitamab, also called TAK-079) works and how safe it is in individuals who have chronic primary immune thrombocytopenia (ITP).

About participating
in the study

The investigational study drug will be compared to a placebo (a substance that looks like the investigational study drug but contains no active medication). The study medication or the placebo will be added to your current treatment for ITP.

Are you ready to participate?

Participation is totally voluntary. It is up to you if you do or do not want to take part. Your decision will not change the medical care you get from your doctors now or in the future.

About mezagitamab (TAK-079), the investigational study drug

The immune system makes antibodies to protect us. In ITP, it makes a mistake and attacks and destroys platelets. Mezagitamab may help by targeting and attaching to the bad antibodies. Doctors are studying what happens as a result of targeting the antibodies in this way. ‘Investigational’ in this study means that the drug has not been approved by regulatory authorities for chronic primary ITP.

When you have ITP, antibodies destroy your platelets, which leads to the increased risk of bleeding

About Participating in the Study



If you qualify, what to expect if you choose to participate

You will be assigned by chance to one of the following treatment groups: mezagitamab or placebo. You have a 2 in 3 chance (66%) of receiving mezagitamab and a 1 in 3 chance (33%) of receiving placebo (no active drug).

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Either mezagitamab (the investigational study drug) or placebo (a substance that looks like the investigational study drug but contains no active medicine) will be added to your current treatment for ITP.

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Treatment will be given as once-weekly injections in two eight-week dosing intervention periods, separated by a non-dosing period.

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8

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The investigational drug and visits for the study will be provided at no cost to you. As a participant, you (and your caregiver, if needed) can be provided with compensation for your time at the study visit, as well as travel arrangements in accordance with local regulations and regulatory approvals in place in your country.

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Study participation may last between 5 to 7 months and includes 15- 22 visits.

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This website is intended only for residents of the United States.

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