Mezagitamab for Immune Thrombocytopenic Purpura

Recruiting at 121 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?

This trial aims to determine if mezagitamab can stabilize platelet counts in adults with immune thrombocytopenia (ITP), a condition where the immune system mistakenly attacks platelets, causing easy bruising or bleeding. Participants will receive either mezagitamab, an experimental treatment, or a placebo, a look-alike without active ingredients, through injections under the skin. Individuals with ITP for at least a year, who have tried other treatments but still experience low platelet counts, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

You may continue your current ITP treatment during the trial if the dose and frequency have been stable for at least 4 weeks before starting the trial and are expected to remain stable throughout the trial. However, certain medications like anticoagulants and specific immunosuppressive agents must be stopped before the trial.

Is there any evidence suggesting that mezagitamab is likely to be safe for humans?

Research has shown that mezagitamab is generally safe for people with immune thrombocytopenia (ITP). Studies have found that mezagitamab can significantly increase platelet counts, benefiting those with ITP. Most people tolerate it well, experiencing no serious side effects.

In a previous study, ITP patients received mezagitamab and showed positive safety results. Most participants managed the treatment well without major problems. Additionally, ongoing research aims to ensure mezagitamab's safety over longer periods.

Current data and studies suggest that mezagitamab is a safe option for managing ITP. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about mezagitamab for treating Immune Thrombocytopenic Purpura (ITP) because it offers a novel approach compared to standard treatments like corticosteroids, immunoglobulins, or thrombopoietin receptor agonists. Mezagitamab is unique because it is a monoclonal antibody administered via a simple subcutaneous injection, which is more convenient for patients. Unlike traditional therapies that often have broad immune-suppressing effects, mezagitamab specifically targets immune pathways implicated in ITP, potentially reducing side effects and improving efficacy. This targeted mechanism of action is what makes mezagitamab a promising candidate in the treatment landscape for ITP.

What evidence suggests that mezagitamab might be an effective treatment for immune thrombocytopenic purpura?

Research has shown that mezagitamab, which participants in this trial may receive, may help treat primary immune thrombocytopenia (ITP). In a previous study, patients who took mezagitamab had more platelets in their blood compared to those who took a placebo. Platelets are important because they help stop bleeding. Mezagitamab also led to lasting improvements in platelet levels and reduced ITP symptoms. This suggests that mezagitamab could be a good option, especially for people who haven't had success with other treatments. ^{1 2 4 6 7}

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

Citations

1. takeda.com takeda.com/newsroom/newsreleases/2024/late-breaking-data-from-phase-2b-study-of-mezagitamab/

Takeda Unveils Promising Phase 2b Results for ... The Phase 2b trial results demonstrated that mezagitamab treatment improved platelet response compared to placebo, across all three dose levels of mezagitamab ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06722235

NCT06722235 | A Study of Mezagitamab in Adults With ... 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 ...

3. ddw-online.com ddw-online.com/mezagitamab-and-the-future-of-itp-treatment-35637-202507/

Mezagitamab and the future of ITP treatment While current treatments are reasonably effective for many, around 20-30% of patients either do not respond or cannot tolerate them.

4. 2minutemedicine.com 2minutemedicine.com/takedas-mezagitamab-delivers-sustained-platelet-boost-in-phase-2-clinical-trials-for-treatment-of-immune-thrombocytopenia-purpura/

Takeda's Mezagitamab Delivers Sustained Platelet Boost ... Mezagitamab achieved a sustained platelet response and symptomatic relief in patients treated for chronic ITP.

5. trialx.com trialx.com/clinical-trials/listings/294825/a-study-of-mezagitamab-in-adults-with-chronic-primary-immune-thrombocytopenia/?&radius=50

A Study of Mezagitamab in Adults With Chronic Primary ... 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 ...

6. checkrare.com checkrare.com/mezagitamab-in-patients-with-immune-thrombocytopenia/

Mezagitamab in Patients With Immune Thrombocytopenia Results showed that through week 16 all groups experienced an increased duration of platelet response with a mean increase with mezagitamab over ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06948318

NCT06948318 | A Continuation Study of Mezagitamab in ... The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time.