BridgeMD
New treatment option for Immune Thrombocytopenic Purpura (ITP)
Official title A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT06722235
What this study is testing
What is Mezagitamab?
Mezagitamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for immune thrombocytopenic purpura (itp).
Also referred to as TAK-079.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The participant has been diagnosed with ITP that has persisted for at least 12 months.
- The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist [TPO-RA])...
- The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for...
- The participant has a mean platelet count of less than (\<)30,000/μL.
- If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during...
You likely can't join if
- The participant has secondary ITP.
- The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
- The participant has had a splenectomy.
- The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
- History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical...
- In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion...
See the full eligibility criteria
- The participant has been diagnosed with ITP that has persisted for at least 12 months.
- The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist [TPO-RA]), defined as having achieved a platelet count ≥50,000/μL.
- The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available...
- The participant has a mean platelet count of less than (\<)30,000/μL.
- If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4...
- If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention...
- The participant has secondary ITP.
- The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
- The participant has had a splenectomy.
- The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
- History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.
- In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
- The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening, and either of the following applies:
- The last dose was received within 6 months before screening.
- The last dose was received between 6 and 12 months before screening, and the participant has a cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.
- The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day 1.
- The participant has any prior exposure to mezagitamab or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.
- The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.
- The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.
- The participant has used the following immunosuppressive agents as specified prior to the first dose of trial treatment: alkylating agents (e.g., cyclophosphamide) within 8 weeks, vinca alkaloids (e.g., vincristine)...
- The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected...
- The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab/placebo formulation. Other protocol defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Durham, North Carolina, United States
- Greenville, North Carolina, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Norfolk, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Garran, Australian Capital Territory, Australia
- Concord, New South Wales, Australia
- Kogarah, New South Wales, Australia
+ 82 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Iowa City, Iowa, United States; Louisville, Kentucky, United States and 96 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.