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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Mezagitamab injection administered SC.
USC Norris Comprehensive Cancer Center - Keck Medicine of USC
Los Angeles, California, United States
NOT_YET_RECRUITINGRocky Mountain Cancer Center
Denver, Colorado, United States
WITHDRAWNGeorgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGEmory University
Atlanta, Georgia, United States
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
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.
Time frame: Up to approximately 108 weeks
Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab
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.
Time frame: Up to approximately 108 weeks
Duration of Platelet Response
The duration of platelet response will be measured by the cumulative number of weeks on which platelet count was ≥30,000/microliters (μL) and ≥50,000/μL throughout the trial.
Time frame: Up to approximately 108 weeks
Duration Between On-Demand Treatment Courses
Time frame: Up to approximately 108 weeks
Time to Initiation of the First On-Demand Treatment Course
Time frame: Up to approximately 108 weeks
Number of Participants With Complete Response
Complete response is defined as achieving platelet counts ≥100,000/μL on at least 2 visits.
Time frame: Up to approximately 108 weeks
Number of Participants With Immune Thrombocytopenia (ITP) Remission
ITP Remission is defined as all platelet counts ≥50,000/μL for at least 24 weeks after any mezagitamab treatment cycle in the absence of further therapy for ITP.
Time frame: Up to approximately 108 weeks
Number of Participants With Reduction in Dose and/or Frequency of Concomitant ITP Medications
Concomitant ITP medications are defined as those given in addition to the trial intervention to treat your ITP. These medications include corticosteroids, thrombopoietin receptor agonists (TPO-RA), or fostamatinib.
Time frame: Up to approximately 108 weeks
Number of Participants Requiring Rescue Therapy
Time frame: Up to approximately 108 weeks
Serum Concentrations of Mezagitamab
Time frame: Pre-dose and at multiple time points post-dose up to Week 104
Number of Participants With Anti-Drug Antibodies (ADA)
Time frame: Pre-dose and at multiple time points post-dose up to Week 104
Number of Participants With Neutralizing Antibody (NAb)
Time frame: Pre-dose and at multiple time points post-dose up to Week 104
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The University of Iowa
Iowa City, Iowa, United States
NOT_YET_RECRUITINGUniversity Of Louisville Brown Cancer Center
Louisville, Kentucky, United States
NOT_YET_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGUniversity of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
NOT_YET_RECRUITINGDuke University Hospital
Durham, North Carolina, United States
NOT_YET_RECRUITINGEast Carolina University
Greenville, North Carolina, United States
NOT_YET_RECRUITING...and 88 more locations