Phase 3 study for people with Immune Thrombocytopenia

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor Takeda

Registry number NCT06948318

Started 14 August 2025 Today 16 October 2026 Estimated completion 29 July 2029

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Canberra Hospital	Garran	ACT	Recruiting
Concord Repatriation General Hospital	Concord	NSW	Not yet recruiting
St George Hospital	Kogarah	NSW	Recruiting
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre	Liverpool	NSW	Recruiting
Westmead Hospital	Westmead	NSW	Recruiting
Peter MacCallum Cancer Centre	Melbourne	VIC	Not yet recruiting
Monash University - Australian Centre for Blood Diseases (ACBD)	Melbourne	VIC	Recruiting
The Alfred Hospital	Melbourne	VIC	Recruiting
Fiona Stanley Hospital	Murdoch	WA	Recruiting
Perth Blood Institute	West Perth	WA	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 150

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

* 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.

Dates on the record

Started 14 August 2025

Estimated completion 29 July 2029

Registry last updated 9 September 2026

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 9 September 2026.
This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT06948318

Sponsor: Takeda

Phase: Phase 3

Status: Recruiting

Condition: Immune Thrombocytopenia

More information: https://clinicaltrials.gov/study/NCT06948318

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

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:

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:
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.
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.

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.

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.