Recruiting
Phase 3

Mezagitamab

Sponsor:

Takeda

Code:

NCT06948318

Conditions

Immune Thrombocytopenic Purpura (ITP)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mezagitamab

Study Details

Brief summary:

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.

Conditions

Immune Thrombocytopenic Purpura (ITP)

Study ID

NCT06948318

Start date

Aug 14, 2025

Status verified date

Sep, 2026

Completion date

Jul 29, 2029

Anticipated

Primary completion date

Jul 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mezagitamab

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.

Interventions

Mezagitamab

Mezagitamab injection administered SC.

Primary outcome measure

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: Up to approximately 108 weeks ]
  • Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab [ Time Frame: Up to approximately 108 weeks ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

David Kuter

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Joseph Shatzel

More Information

Sponsor

Takeda

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • TAK-079
  • Immune Thrombocytopenia
  • Chronic Primary Immune Thrombocytopenia
  • Blood Platelet Disorders
  • Hematologic Diseases
  • Cytopenia
  • Purpura
  • Hemorrhagic Disorders
  • Autoimmune Diseases
  • Immune System Diseases
  • Hemorrhage
  • Skin Manifestations
  • Purpura, Thrombocytopenic, Idiopathic
  • Purpura, Thrombocytopenic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Takeda on 2026-09-09.