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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06722235
Registration number
NCT06722235
Ethics application status
Date submitted
5/12/2024
Date registered
9/12/2024
Date last updated
25/06/2025
Titles & IDs
Public title
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia
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Secondary ID [1]
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2024-514401-54-00
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Secondary ID [2]
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TAK-079-3002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Immune Thrombocytopenic Purpura (ITP)
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Inflammatory and Immune System
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Mezagitamab
Treatment: Drugs - Placebo
Experimental: Mezagitamab - Participants will receive mezagitamab injection, SC, once weekly (QW). They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.
Placebo comparator: Placebo - Participants will receive mezagitamab placebo-matching injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.
Treatment: Drugs: Mezagitamab
Mezagitamab injection administered SC.
Treatment: Drugs: Placebo
Mezagitamab placebo-matching injection administered SC.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Durable Platelet Response
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Week 24
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Secondary outcome [1]
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Cumulative Number of Weeks with a Platelet Count of =50,000/µL
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Assessment method [1]
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The cumulative number of weeks in which the platelet count is =50,000/µL through Week 24.
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Timepoint [1]
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Up to Week 24
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Secondary outcome [2]
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Time to First Platelet Count =50,000/µL
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Assessment method [2]
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Timepoint [2]
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Up to Week 24
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Secondary outcome [3]
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The Cumulative Number of Weeks with a Platelet Count of =30,000/µL
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Assessment method [3]
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The cumulative number of weeks in which the platelet count is =30,000/µL, and at least doubled from baseline through Week 24.
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Timepoint [3]
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Up to Week 24
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Secondary outcome [4]
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Percentage of Participants with Complete Platelet Response
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Assessment method [4]
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Complete platelet response is defined as a platelet count =100,000/µL on at least 2 visits through Week 24.
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Timepoint [4]
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Up to Week 24
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Secondary outcome [5]
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Percentage of Participants with Platelet Response at Week 16
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Assessment method [5]
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Platelet response is defined as a platelet count =50,000/µL before investigational medicinal product (IMP) administration at the Week 16 visit.
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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Change from Baseline in the Symptoms Domain Score of the Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) at Weeks 16 and 24
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Assessment method [6]
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ITP-PAQ is a 44-item participant reported outcome (PRO) measure that assesses disease-specific health-related quality of life (HRQoL) that includes 10 domains: Symptoms, Fatigue/Sleep, Physical Health - Bother, Physical Health - Activity, Emotional Health - Psychological, Emotional Health - Fear, Overall Quality of Life (QoL), Social Activity, Women's Reproductive Health (including Fertility subscale, and Menstrual Symptoms subscale), and Work. The 6-item symptoms domain is scored from 0 to 100, with higher scores representing improvement of symptoms.
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Timepoint [6]
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Weeks 16 and 24
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Secondary outcome [7]
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Percentage of Participants Receiving Rescue Therapy
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Assessment method [7]
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Timepoint [7]
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Up to Week 24
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Secondary outcome [8]
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Time to First Rescue Therapy
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Assessment method [8]
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Timepoint [8]
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Up to Week 24
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Secondary outcome [9]
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Percentage of Participants with Bleeding Events
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Assessment method [9]
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Bleeding events are defined as Grade =2 in the skin domain, or Grade =1 in the mucosal domain, or Grade =1 in the organ domain, in the immune thrombocytopenia-specific bleeding assessment tool (ITP-BAT) through Week 24.
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Timepoint [9]
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Up to Week 24
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Secondary outcome [10]
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Serum Concentration of Mezagitamab During and After Intervention
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Assessment method [10]
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Timepoint [10]
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Predose on Day 1 and at multiple time points post-dose up to Day 169
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Secondary outcome [11]
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Number of Participants with Anti-drug Antibodies (ADA)
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Assessment method [11]
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Timepoint [11]
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Predose on Day 1 and at multiple time points post-dose up to Day 169
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Secondary outcome [12]
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Change in ADA Titers Over Time
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Assessment method [12]
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Timepoint [12]
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Up to Day 169
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Secondary outcome [13]
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Number of Participants with Neutralizing ADA
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Assessment method [13]
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Timepoint [13]
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Predose on Day 1 and at multiple time points post-dose up to Day 169
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Eligibility
Key inclusion criteria
Key
1. The participant has been diagnosed with ITP that has persisted for at least 12 months.
2. The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist [TPO-RA]), defined as having achieved a platelet count =50,000/µL.
3. The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000/µL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
4. The participant has a mean platelet count of <30,000/µL.
5. If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.
6. If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. The participant has secondary ITP.
2. The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
3. The participant has had a splenectomy within 3 months before signing the ICF.
4. The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
5. 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.
6. 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.
7. The participant has received anti-cluster of differentiation (CD)20 treatment within 12 months before screening, and either of the following applies:
1. The last dose was received within 6 months before screening.
2. The last dose was received between 6, and 12 months before screening, and the participant has a cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.
8. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day 1.
9. The participant has any prior exposure to mezagitamab or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.
10. The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.
11. 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.
12. The participant has used the following immunosuppressive agents as specified prior to the first dose of trial treatment: alkylating agents (e.g., cyclophosphamide) within 8 weeks, vinca alkaloids (e.g., vincristine) within 4 weeks, sulfones (e.g., dapsone) within 3 weeks, antiproliferative agents: (e.g., mycophenolate mofetil, and azathioprine) within 2 weeks, and calcineurin inhibitors: (e.g., cyclosporine) within 2 weeks.
13. The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected that any treatment for thrombocytopenia other than the participant's standard-of-care ITP therapy (e.g., rescue therapy, administration of blood products) may be used between screening, and Day 1.
14. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab/placebo formulation.
Other protocol defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/12/2027
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Actual
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Sample size
Target
171
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
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South Eastern Sydney Local Health District - Kogarah
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment hospital [5]
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The Perth Blood Institute Limited - West Perth
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Recruitment postcode(s) [1]
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- Garran
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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6005 - West Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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District of Columbia
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Wisconsin
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China
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State/province [10]
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Beijing
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Country [11]
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China
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Guangdong
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Country [12]
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China
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Hebei
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China
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Henan
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China
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Hubei
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China
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Jiangsushe
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China
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Jiangxi
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China
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Liaoning
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China
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Shanghai
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China
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Sichuan
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China
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Tianjin
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China
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Yunnan
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China
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Zhejiang
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China
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Jinan
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China
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State/province [24]
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Nanning
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Japan
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State/province [25]
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Chiba
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Japan
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State/province [26]
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Tokyo
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Country [27]
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Turkey
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State/province [27]
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Ankara
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Turkey
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State/province [28]
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Aydin
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Turkey
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State/province [29]
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Edirne
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United Kingdom
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Hampshire
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United Kingdom
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Leicestershire
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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 low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \[SC\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).
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Trial website
https://clinicaltrials.gov/study/NCT06722235
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Takeda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Takeda Contact
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Address
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Country
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Phone
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+1-877-825-3327
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06722235
Download to PDF