A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
The participant has had any thrombotic or embolic event within 12 months before signing the ICF.
The participant has had a splenectomy within 3 months before signing the ICF.
The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
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.
Trial design
Design model
Single group
Treatments tested in this trial
Mezagitamab
DrugMezagitamab injection administered SC.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: MezagitamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeksSecondary outcomes
1
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 weeks2
Duration Between On-Demand Treatment Courses
Time frame
Up to approximately 108 weeks3
Time to Initiation of the First On-Demand Treatment Course
Time frame
Up to approximately 108 weeks4
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 Source ClinicalTrials.gov