Immune Thrombocytopenic Purpura
Conditions
Interventions
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 n
Sponsors
Shikamura Mitsuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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: -The last dose was received within 6 months before screening. -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Time Frame: Up to approximately 108 weeks 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. 2.Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab Time Frame: Up to approximately 108 weeks 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Duration of Platelet Response Time Frame: Up to approximately 108 weeks The duration of platelet response will be measured by the cumulative number of weeks on which platelet count was >=30,000/microliter and >=50,000/microliter throughout the trial. 2.Duration Between On-Demand Treatment Courses Time Frame: Up to approximately 108 weeks 3.Time to Initiation of the First On-Demand Treatment Course Time Frame: Up to approximately 108 weeks 4.Number of Participants With Complete Response Time Frame: Up to approximately 108 weeks Complete response is defined as achieving platelet counts >=100,000/microliter on at least 2 visits. 5.Number of Participants With Immune Thrombocytopenia (ITP) Remission Time Frame: Up to approximately 108 weeks ITP Remission is defined as all platelet counts >=50,000/microliter for at least 24 weeks after any mezagitamab treatment cycle in the absence of further therapy for ITP. 6.Number of Participants With Reduction in Dose and/or Frequency of Concomitant ITP Medications Time Frame: Up to approximately 108 weeks 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. 7.Number of Participants Requiring Rescue Therapy Time Frame: Up to approximately 108 weeks 8.Serum Concentrations of Mezagitamab Time Frame: Pre-dose and at multiple time points post-dose up to Week 104 9.Number of Participants With Anti-Drug Antibodies (ADA) Time Frame: Pre-dose and at multiple time points post-dose up to Week 104 10.Number of Participants With Neutralizing Antibody (NAb) Time Frame: Pre-dose and at multiple time points post-dose up to Week 104 | — |
Countries
Australia, Bulgaria, China, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden, Turkey, United Kingdom, United States
Contacts
Public ContactContact for Clinical Trial Information
Takeda Pharmaceutical Company Limited
Outcome results
None listed