Early access
Sign in
Taking people in ItalyPhase 3

Long-term study of mezagitamab for adults with chronic immune thrombocytopenia

Tests mezagitamab over a longer time in adults with chronic primary immune thrombocytopenia.

Key facts

Who runs it
Takeda
Where
Bologna, Catania, Milan, Monza, Naples, Novara, Rome, Trieste, Turin, and Vicenza, ItalySee the 11 sitesAlso in 19 other countries, 118 sites
Trial code
Registry title
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Status
Recruiting
Phase
Phase 3
People taking part
150 people, planned
Started
14 Aug 2025
Expected to end
29 Jul 2029
Type of study
Interventional
Treatments tested
  • Mezagitamab
Record updated
30 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic primary immune thrombocytopenia (ITP) who completed the earlier mezagitamab studies TAK-079-3002 or TAK-079-1004.

Age
18 years and older
Sex
All sexes
Disease stage
Chronic primary immune thrombocytopenia (low platelets caused by the immune system).
Earlier treatment
People must have completed TAK-079-3002 or TAK-079-1004 to the end of the trial. People from TAK-079-1004 must have had a platelet response to mezagitamab in that trial.

Main reasons for not taking part

  • Severe allergic reaction to recombinant proteins or ingredients in the mezagitamab product
  • From TAK-079-1004: blood clot event within 12 months, or spleen removal within 3 months
  • From TAK-079-1004: active hepatitis B, hepatitis C or HIV infection
  • From TAK-079-1004: cancer within 5 years, except treated non-melanoma skin cancer or cervical carcinoma in situ
  • From TAK-079-1004: recent anti-CD20 treatment, antibodies for the immune system, blood thinners, live vaccines or certain immune-suppressing drugs

The registry criteria, word for word

Show all 14 criteriaShow less

Other criteria

  • Key Inclusion Criteria:; 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
  • Key Exclusion criteria:; For TAK-079-3002 participants:
  • 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 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 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
  • 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

Where in Italy

Also in 19 other countries, 118 sites

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
  • ARNAS Garibaldi Di CataniaCatania, ItalyTaking people
  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
  • Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
  • Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
  • Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
  • Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
  • Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyTaking people
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
  • Azienda Unita Locale Socio Sanitaria N 8 BericaVicenza, ItalyTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • MezagitamabTreatment being tested

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Long-term study of mezagitamab for adults with chronic immune thrombocytopeniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
30 October 2026