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Looking for participantsPhase3

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Sponsor: Takeda

NCT ID: NCT06722235

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), Placebo (drug)
How long the study runs
Study runs about 37 months (dates as stated)
About the drug or intervention
Mezagitamab — drug: Mezagitamab injection administered SC. · Placebo — drug: Mezagitamab-matching placebo 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
171
Started
2025-02-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for immune thrombocytopenic purpura (itp)
  • • Phase3 - 171 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 low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \[SC\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).

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
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

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

confirmed by negativeCD19differentiation 19 positive

Treatment history

Treatments you must have had:

  • ✓ is defined as failure to achieve a sustained platelet count of at least 50

What the study is looking for

  • ✓The participant has been diagnosed with ITP that has persisted for at least 12 months.
  • ✓The participant has a mean blood clotting cell count of less than (\<)30,000/μL.

Who cannot take part

  • ✗The participant has secondary ITP.
  • ✗The participant has had any thrombotic or embolic event within 12 months before signing the agreement to take part 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 cancer (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated...
See the full criteria
Key Inclusion Criteria: 1. The participant has been diagnosed with ITP that has persisted for at least 12 months. 2. 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. 3. 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 second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000/μL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy. 4. The participant has a mean platelet count of less than (\<)30,000/μL. 5. 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 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial. 6. 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. Key Exclusion Criteria: 1. The participant has secondary ITP. 2. The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF). 3. The participant has had a splenectomy. 4. The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV). 5. 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. 6. 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. 7. 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 cluster of differentiation 19 positive (CD19+) count below the lower limit of normal. 8. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before screening. 9. 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. 10. The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment. 11. 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. 12. 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) within 4 weeks, sulfones (e.g., dapsone) within 3 weeks, antiproliferative agents: (e.g., mycophenolate mofetil, and azathioprine) within 2 weeks, and calcineurin inhibitors: (e.g., cyclosporine) within 2 weeks. 13. 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 that any treatment for thrombocytopenia other than the participant's standard-of-care ITP therapy (e.g., rescue therapy, administration of blood products) may be used between screening, and Day 1. 14. 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.

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 SE1 9RT, United Kingdom

Recruiting
Site contact (verified)
Vickie McDonaldPrincipal Investigator

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool L7 8XP, United Kingdom

Recruiting
Site contact (verified)
David SimcoxPrincipal Investigator

Greater Glasgow Health Board

Glasgow G312ER, United Kingdom

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)
Quentin HillPrincipal 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

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