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New treatment option for Immune Thrombocytopenic Purpura (ITP)
Official title A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT06948318
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 lower number of platelets, making it easier to bruise or bleed.
- Phase 3: a large, late-stage study
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
- 1\. The participant has completed TAK-079-3002 (end of trial [EOT]) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to...
You likely can't join if
- For TAK-079-3002 participants: 1\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients...
- The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
- The participant has had a splenectomy within 3 months before signing the ICF.
- The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), 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
- 1\. The participant has completed TAK-079-3002 (end of trial [EOT]) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for "platelet...
- For TAK-079-3002 participants: 1\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation. For TAK-079-1004 participants:
- The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
- The participant has had a splenectomy within 3 months before signing the ICF.
- The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), 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 CD19+ count below the lower limit of normal.
- The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1.
- The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
- The participant has used anticoagulants (for example, vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to Visit 1. 10 The participant has received a live or live-attenuated vaccine within 4 weeks...
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
- 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
- Liverpool, New South Wales, Australia
+ 77 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 91 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.