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Looking for participantsPhase3

A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Sponsor: Takeda

NCT ID: NCT06948318

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mezagitamab (drug)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Mezagitamab — drug: Mezagitamab injection administered SC.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
150
Started
2025-08-14
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for immune thrombocytopenic purpura (itp)
  • • Phase3 - 150 participants
  • • Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with immune thrombocytopenic purpura (itp)

Where?

  • • Leicester - University Hospitals of Leicester NHS Trust
  • • Southampton - Southampton General Hospital
  • • Southwark - Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
  • • Liverpool - Royal Liverpool and Broadgreen University Hospitals NHS Trust
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Immune Thrombocytopenic Purpura (ITP)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD19

Who cannot take part

  • ✗For TAK-079-3002 participants:
  • ✗1\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients...
  • ✗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.
See the full criteria
* Key Inclusion 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 response" specified for that trial during either the main study or open-label extension. * Key Exclusion criteria: 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. 11\. 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. 12\. 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 Is This Study? (10 UK sites)

University Hospitals of Leicester NHS Trust

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Mamta GargPrincipal Investigator

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Rashid KazmiPrincipal Investigator

Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust

Southwark DE1 9RT, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Vickie McDonaldPrincipal Investigator

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool L7 8XP, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
David SimcoxPrincipal Investigator

Greater Glasgow Health Board

Glasgow G312ER, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Bagot CatherinePrincipal Investigator

University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting
Site contact (verified)
David SuttonPrincipal Investigator

Leeds Teaching Hospitals NHS Trust

Leeds LS9 TF, United Kingdom

Recruiting
Site contact (verified)
Hill QuentinPrincipal Investigator

Barts Health NHS Trust, Royal London Hospital

London E11BB, United Kingdom

Recruiting
Site contact (verified)
Chen FrederickPrincipal Investigator

University College London Hospitals

London NW1 2PG, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Marie Ann ScullyPrincipal Investigator

Imperial College Healthcare NHS Trust

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)
Nicola CooperPrincipal Investigator

How to Get in Touch

Takeda Contact

Sponsor contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09