Mezagitamab

DRUG9 trials

Sponsors

Takeda Development Center Americas Inc., Millennium Pharmaceuticals, Inc., Takeda

Conditions

Chronic Primary Immune ThrombocytopeniaGlomerulonephritisIgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also known as Berger's disease)Immune Thrombocytopenic Purpura (ITP)Kidney DiseaseMultiple MyelomaRelapsed and/or Refractory Multiple Myeloma (RRMM)Relapsed/Refractory

Phase 1

A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)

CompletedNCT03439280

Millennium Pharmaceuticals, Inc.Multiple Myeloma, Relapsed/Refractory

Start: 2018-04-20End: 2022-01-28Updated: 2023-02-24

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)

TerminatedNCT04776018

TakedaRelapsed and/or Refractory Multiple Myeloma (RRMM)

Start: 2021-04-20End: 2023-11-09Updated: 2024-10-02

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

CompletedNCT05174221

TakedaGlomerulonephritis, Kidney Disease

Start: 2022-11-09End: 2025-12-15Updated: 2026-01-26

Phase 3

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

RecruitingNCT06722235

TakedaImmune Thrombocytopenic Purpura (ITP)

Start: 2025-02-27End: 2027-12-28Target: 171Updated: 2026-03-06

A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

RecruitingNCT06948318

TakedaImmune Thrombocytopenic Purpura (ITP)

Start: 2025-08-14End: 2029-07-29Target: 150Updated: 2026-04-01

A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition

RecruitingNCT06963827

TakedaKidney Disease

Start: 2025-07-15End: 2030-01-14Target: 347Updated: 2026-04-01

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants with Primary IgA Nephropathy in Combination with Stable Background Therapy

Not yet recruitingCTIS2025-520825-19-00

Takeda Development Center Americas Inc.IgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also known as Berger's disease)

Target: 83Updated: 2025-11-05

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants with Chronic Primary Immune Thrombocytopenia

RecruitingCTIS2024-514401-54-00

Takeda Development Center Americas Inc.Chronic Primary Immune Thrombocytopenia

Start: 2025-11-13Target: 73Updated: 2025-12-04

A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults with Chronic Primary Immune Thrombocytopenia

RecruitingCTIS2025-521692-31-00

Takeda Development Center Americas Inc.Chronic Primary Immune Thrombocytopenia

Start: 2025-12-19Target: 77Updated: 2025-12-08

Related Papers

Trial in progress: Study design of a randomized, phase 3 trial evaluating the efficacy and safety of mezagitamab (TAK-079) compared with placebo in adults with chronic primary immune thrombocytopenia

Blood2025-11-03

#47 Safety, tolerability, and efficacy of mezagitamab (TAK-079) as add-on to standard of care therapy in individuals with primary IgA nephropathy: results from a Phase 1b study

Nephrology Dialysis Transplantation2025-10-01

Clinical study outcomes in IgA nephropathy: A systematic literature review and narrative synthesis.

2025-06-101 citations

Phase 1b study of the anti-CD38 antibody mezagitamab in patients with relapsed/refractory multiple myeloma

Blood Neoplasia2024-09-191 citations

1069 IL-12 mRNA monotherapy is effective in murine tumors resistant to checkpoint inhibition

Regular and Young Investigator Award Abstracts2023-10-311 citations

The SUMOylation inhibitor subasumstat potentiates rituximab activity by IFN1-dependent macrophage and NK cell stimulation

Blood2022-02-2866 citations

Phase 1b/2 Study of the First-in-Class SUMO-Activating Enzyme Inhibitor TAK-981 in Combination with Monoclonal Antibodies in Patients with Triple-Class Refractory Multiple Myeloma

Blood2021-11-052 citations

A small-molecule SUMOylation inhibitor activates antitumor immune responses and potentiates immune therapies in preclinical models.

2021-09-15105 citations

Mezagitamab Induces Immunomodulatory Effect in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Blood2020-11-044 citations

A phase Ib study of TAK-079, an investigational anti-CD38 monoclonal antibody (mAb) in patients with relapsed/ refractory multiple myeloma (RRMM): Preliminary results.

Journal of Clinical Oncology2020-05-2021 citations

Preliminary Results from a Phase 1b Study of TAK-079, an Investigational Anti-CD38 Monoclonal Antibody (mAb) in Patients with Relapsed/ Refractory Multiple Myeloma (RRMM)

Blood2019-11-1326 citations

The Binding of CD38 Therapeutics to Red Blood Cells and Platelets Subverts Depletion of Target Cells

Blood2019-11-133 citations

A Single Administration of the Cytolytic CD38 Antibody TAK-079 to Healthy Subjects: Tolerability, Pharmacokinetics and Pharmacodynamics

Blood2018-11-296 citations