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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (10 UK sites)
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
Southwark SE1 9RT, United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool L7 8XP, United Kingdom
Greater Glasgow Health Board
Glasgow G312ER, United Kingdom
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds LS9 TF, United Kingdom
Barts Health NHS Trust, Royal London Hospital
London E11BB, United Kingdom
University College London Hospitals
London NW1 2PG, United Kingdom
Imperial College Healthcare NHS Trust
London W12 0HS, United Kingdom
How to Get in Touch
Takeda Contact
Sponsor contactCONTACT
