Mezagitamab for Immune Thrombocytopenic Purpura

Recruiting at 41 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Must not be taking: Anticoagulants, Immunosuppressives, Monoclonal antibodies, others

Disqualifiers: Secondary ITP, Thrombotic events, Active infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

171 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \[SC\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

Adults with chronic primary immune thrombocytopenia (ITP) who haven't had enough improvement from at least one first-line therapy like corticosteroids and one second-line treatment. They should have a stable dose of any current ITP treatments, not be pregnant, and have a low platelet count (<30,000/μL).

Inclusion Criteria

My average platelet count is below 30,000.

I am not pregnant, as confirmed by a test.

I have been diagnosed with ITP for at least 12 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mezagitamab or placebo subcutaneously once weekly for up to 6 months

24 weeks

Several visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with open-label mezagitamab if eligible

What Are the Treatments Tested in This Trial?

Interventions

• Mezagitamab

Trial Overview The trial is testing mezagitamab—a medication given under the skin—against a placebo to see if it can stabilize platelet counts in adults with ITP over six months. Participants will make several clinic visits and may join a follow-up study.

How Is the Trial Designed?

Group I: Mezagitamab Experimental Treatment 1 Intervention

Participants will receive mezagitamab injection, SC, once weekly (QW). They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive mezagitamab placebo-matching injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier