Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Annette Von Drygalski (ucsd)
Headshot of Annette Von Drygalski
Annette Von Drygalski

Description

Summary

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. 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. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.

Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.

During the study, participants will visit their study clinic several times.

Official Title

A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia

Keywords

Immune Thrombocytopenic Purpura (ITP), TAK-079, Immune Thrombocytopenia, Chronic Primary Immune Thrombocytopenia, Blood Platelet Disorders, Hematologic Diseases, Cytopenia, Purpura, Hemorrhagic Disorders, Autoimmune Diseases, Immune System Diseases, Hemorrhage, Skin Manifestations, Purpura, Thrombocytopenic, Idiopathic, Purpura, Thrombocytopenic, Thrombocytopenic Purpura, Mezagitamab

Eligibility

You can join if…

Open to people ages 18 years and up

  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 response" specified for that trial during either the main study or open-label extension.

You 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 used in the mezagitamab formulation.

For TAK-079-1004 participants:

  1. The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
  2. The participant has had a splenectomy within 3 months before signing the ICF.
  3. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  4. 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.
  5. 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.
  6. The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening and either of the following applies:
    1. The last dose was received within 6 months before screening.
    2. 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.
  7. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1.
  8. The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
  9. 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 prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.

  1. The participant has used the following immunosuppressive agents as specified prior to Visit 1: alkylating agents (for example, cyclophosphamide) within 8 weeks, vinca alkaloids (for example, vincristine) within 4 weeks, sulfones (for example, dapsone) within 3 weeks, antiproliferative agents: (for example, mycophenolate mofetil and azathioprine) within 2 weeks, and calcineurin inhibitors: (for example, cyclosporine) within 2 weeks.
  2. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.

Other protocol defined inclusion/exclusion criteria may apply.

Locations

  • University of California San Diego Center for Bleeding and Clotting Disorders not yet accepting patients
    San Diego California 92121 United States
  • USC Norris Comprehensive Cancer Center - Keck Medicine of USC not yet accepting patients
    Los Angeles California 90033 United States
  • Oregon Health & Science University accepting new patients
    Portland Oregon 97239 United States
  • Massachusetts General Hospital accepting new patients
    Boston Massachusetts 02114 United States

Lead Scientist at University of California Health

  • Annette Von Drygalski (ucsd)
    Dr. von Drygalski is the Director of the Hemophilia and Thrombosis Treatment Center at UCSD (http://health.ucsd.edu/specialties/hemophilia/Pages/default.aspx) and her research interests involve basic, translational and clinical science in the field of hemostasis and thrombosis, specifically hemophilia. Dr. von Drygalski collaborates with Laurent O. Mosnier and John H.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Takeda
Links
more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
ID
NCT06948318
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated