| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06948318 | A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia | PHASE3 | RECRUITING | 150 | — | — | Aug 14, 2025 | Jul 29, 2029 | Jun 5, 2026 | 108 | United States, Australia +12 |
| NCT06722235 | A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia | PHASE3 | RECRUITING | 171 | — | — | Feb 27, 2025 | Mar 16, 2028 | May 22, 2026 | 112 | United States, Australia +14 |
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.
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.
| 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 injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses. |
| Name | Type | Description |
|---|---|---|
| Mezagitamab | DRUG | Mezagitamab injection administered SC. |
| Placebo | DRUG | Mezagitamab-matching placebo injection administered SC. |
* 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 ...