Mezagitamab for Platelet Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on the safety and effectiveness of mezagitamab for treating primary immune thrombocytopenia (ITP), a condition where the immune system attacks platelets, increasing the risk of bruising or bleeding. Participants who completed specific previous mezagitamab studies can join this continuation study for additional treatment if they meet certain criteria. It suits those who participated in earlier mezagitamab studies and wish to continue treatment. During the trial, participants will visit the clinic several times for evaluation and treatment. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before joining. For example, you must stop using anticoagulants (blood thinners) 3 weeks before the trial and certain immunosuppressive agents like cyclophosphamide 8 weeks before. It's best to discuss your current medications with the trial team to see if any need to be stopped.
Is there any evidence suggesting that mezagitamab is likely to be safe for humans?
Research has shown that mezagitamab is generally safe and well-tolerated. In earlier studies, participants did not encounter any new safety issues. Most side effects were mild and similar to those in individuals who took a placebo (a harmless pill used to test the effect of a drug). The treatment rapidly increased platelet counts, a positive sign for people with ITP, a condition where the immune system destroys cells that help stop bleeding. This suggests that mezagitamab could be a safe option for managing ITP over time.12345
Why do researchers think this study treatment might be promising?
Mezagitamab is unique because it offers an innovative approach to treating platelet disorders. Unlike standard treatments, which often focus on managing symptoms, Mezagitamab is designed to target the underlying causes of platelet dysfunction. This experimental drug works by modulating specific pathways involved in platelet production and function, potentially leading to more effective and lasting results. Researchers are excited about Mezagitamab as it promises improved efficacy and safety compared to existing therapies, bringing hope to patients with limited options.
What evidence suggests that mezagitamab might be an effective treatment for primary immune thrombocytopenia?
Research has shown that mezagitamab can increase platelet counts in people with primary immune thrombocytopenia (ITP). In one study, all doses of mezagitamab improved platelet counts more than a placebo. Another study found that weekly doses of mezagitamab led to better platelet counts in 10 out of 11 participants. The increase in platelet counts varied with the dose, with some patients experiencing nearly 10 extra weeks of benefit compared to those on a placebo. This trial will evaluate mezagitamab as an on-demand treatment for eligible participants, suggesting it could help manage ITP by boosting platelet counts.12678
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
This trial is for adults with chronic primary immune thrombocytopenia (ITP), a condition causing low platelet counts and increased bleeding/bruising risk. Only those who completed previous mezagitamab studies TAK-079-3002 or TAK-079-1004 can join to assess long-term safety and effectiveness of mezagitamab.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive on-demand treatment with mezagitamab based on pre-specified criteria and investigator's clinical judgement
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Continuation of treatment to evaluate long-term safety and efficacy of mezagitamab
What Are the Treatments Tested in This Trial?
Interventions
- Mezagitamab
Trial Overview
The study tests the long-term safety, tolerance, effectiveness, and pharmacokinetics of mezagitamab in adults with ITP. Participants will receive ongoing treatment with mezagitamab under specific protocol conditions during multiple clinic visits.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Eligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
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.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/3049/552889/Trial-in-progress-Study-design-of-a-randomizedTrial in progress: Study design of a randomized, phase 3 trial ...
A Phase II study (NCT04278924) demonstrated that weekly doses of mezagitamab 600 mg for 8 weeks had promising signs of efficacy: 10/11 ...
Trial in progress: Study design of a randomized, phase 3 ...
A Phase II study (NCT04278924) demonstrated that weekly doses of mezagitamab 600 mg for 8 weeks had promising signs of efficacy: 10/11 participants treated with ...
OC 75.3 - Results from a phase 2 study on mezagitamab for...
The mean increase in duration of platelet response with mezagitamab over placebo was 4.9±1.6 (SE) weeks for 100mg, 6.9±2.1 for 300mg, and 9.6± ...
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 ...
6.
hcplive.com
hcplive.com/view/mezagitamab-achieves-platelet-response-favorable-safety-in-itp-treatmentMezagitamab Achieves Platelet Response, Favorable ...
Mezagitamab demonstrated no new safety signals and rapid increases in platelet counts across Phase 2b data in treating persistent or chronic ITP ...
7.
globalgenes.org
globalgenes.org/raredaily/takeda-reports-positive-topline-results-from-phase-2-study-in-itp/Takeda Reports Positive Topline Results from Phase 2 ...
Mezagitamab has been generally safe and well tolerated across all three cohorts. All mezagitamab doses tested demonstrated a higher platelet ...
Mezagitamab and the future of ITP treatment
The trial demonstrated that mezagitamab was highly safe, with adverse events mostly mild and similar across placebo and treatment arms. Beyond ...
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