Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mezagitamab · 6 trials · 6 indications
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2. A serious TEAE is a TEAE that meets 1 or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or was otherwise considered medically important.
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2.
Proteinuria will be assessed by urine protein to creatinine ratio (UPCR) calculated from a 24-hour urine collection.
Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24.
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational medicinal product (IMP).
A related AE is an AE that is considered related to the IMP. Related TEAEs are defined as related AEs with start dates at the time of or following the first exposure to IMP.
An SAE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
AEs of special interest are AEs that are considered specific to the IMP.
The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
The severity of TEAEs will be graded using NCI-CTCAE version 5.0.
The severity of TEAEs will be graded using NCI-CTCAE version 5.0.
TEAEs were any untoward medical occurrence (called an adverse event \[AE\]) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
DLTs were defined as any of the following events: Grade 4 laboratory abnormalities, except those events that were clearly due to extraneous causes; nonhematologic TEAEs of grade greater than or equal to (\>=3) except grade 3 nausea/vomiting, fatigue lasting less than 72 hours, elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that resolves to grade less than or equal to (\<=)1 or baseline within 7 days, injection reaction (IR) that responds to symptomatic treatment; Hematologic TEAEs of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade \>=4, except grade \>=3 hemolysis, grade 3 low platelet or higher count with clinically meaningful bleeding; and an incomplete recovery from treatment-related toxicity causing a greater than (\>) 2-week delay in the next scheduled injection before the initiation of Cycle 2 will be considered a DLT.
AE Grades were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.
TEAEs were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
TEAEs leading to discontinuation were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug leading to discontinuation of any of the study treatment when given in combination.
TEAEs were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. Dose modification includes dose delayed, reduced, and drug discontinued permanently. Dose reduced includes scenarios where the dose was skipped, held, or missed. Dose modifications also refer to a modification of any drug in the study treatment when given in combination.
ORR is defined as the percentage of participants who achieved a partial response (PR) better during the study. PR is defined as \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 milligram per (mg/) 24 hours. If serum and urine M protein are not measurable, \>= 50% decrease in difference between involved and uninvolved free light chain (FLC) levels is required in place of M protein criteria.
| Arm | Type | Description |
|---|---|---|
| Mezagitamab | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive mezagitamab-matching placebo injections, SC for approximately 22 weeks. |
| Open-label Mezagitamab | EXPERIMENTAL | Participants will receive mezagitamab injections, SC for approximately 22 weeks. |
| Arm A: Mezagitamab + Placebo | EXPERIMENTAL | Participants will receive mezagitamab up to Week 24, followed by placebo up to Week 48, followed by an observation period up to Week 70. |
| Arm B: Mezagitamab | EXPERIMENTAL | Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70. |
| Arm C: Placebo | ACTIVE_COMPARATOR | Participants will receive placebo up to Week 48, followed by an observation period up to Week 70. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | EXPERIMENTAL | Mezagitamab 45 mg, subcutaneously (SC), once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | EXPERIMENTAL | Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | EXPERIMENTAL | Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | EXPERIMENTAL | Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | EXPERIMENTAL | Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | EXPERIMENTAL | Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD. |
| Phase 2a: Mezagitamab | EXPERIMENTAL | Mezagitamab, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. TAK-079 dose for this phase was to be determined based on review of the available safety, efficacy, pharmacokinetic, and pharmacodynamic data obtained from the Phase 1 portion of the study. However, Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan. |
| Name | Type | Description |
|---|---|---|
| Mezagitamab | DRUG | Mezagitamab injection administered SC. |
| Placebo | DRUG | Mezagitamab-matching placebo injections administered SC. |
| Pomalidomide | DRUG | Pomalidomide orally. |
| Dexamethasone | DRUG | Dexamethasone orally. |
* 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 ...
Mezagitamab is an investigational drug being studied for immune thrombocytopenic purpura (ITP), kidney disease including IgA nephropathy, and antibody-mediated rejection. It is in Phase 2 and Phase 3 clinical trials for these conditions. Mezagitamab is not yet approved by regulatory authorities.
Mezagitamab targets CD38, a protein found on the surface of certain immune cells. By binding to CD38, it may modulate immune responses involved in diseases like immune thrombocytopenic purpura and IgA nephropathy. The drug is classified as a binding agent against this molecular target.
Mezagitamab is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials of the drug across multiple countries, including the United States, Japan, and European nations.
Mezagitamab is in Phase 2 and Phase 3 clinical development. It is being studied in Phase 3 trials for chronic primary immune thrombocytopenia and IgA nephropathy, and has completed a Phase 1 study in IgA nephropathy. The drug remains investigational and is not FDA approved.
Mezagitamab has active trials including NCT06722235 and NCT06948318 for chronic primary immune thrombocytopenia, and NCT06963827 for IgA nephropathy. A completed Phase 1 trial, NCT05174221, studied the drug in IgA nephropathy. These trials are recruiting or have finished across multiple countries.
Mezagitamab is also known by the code name TAK-079, which was used in earlier development stages. The drug is being studied under the name Mezagitamab in current clinical trials for immune thrombocytopenic purpura and kidney diseases.