Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004103-12 | EudraCT Number | ||
| jRCT2031220408 | Registry Identifier | jRCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot.
The main aim of the study is to check for side effects from taking TAK-079 at three different dose levels. Another aim is to learn if TAK-079 can increase the platelet count in people with ITP.
In addition to receiving stable background therapy for ITP, participants will receive an injection of either TAK-079 or a placebo once a week for 2 months. A placebo looks like TAK-079 but will not have any medicine in it. After treatment, all participants will be followed-up for another 2 months.
Then, participants who received TAK-079 will continue to be followed-up for an extra 4 months. Participants who received the placebo and would like to receive TAK-079 may be able to do this in an extension period in the study.
The drug being tested in this study is called TAK-079. TAK-079 is being tested to treat people who have primary immune thrombocytopenia (ITP). This study will evaluate the safety and biologic activity of TAK-079 or matching placebo in combination with stable ITP background therapy.
The study will enroll approximately 36 to 54 participants. In Part A of the study, participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups. Those who received placebo in this period will have the choice to receive TAK-079 after a safety follow-up period and will be randomized to one of the two open-label TAK-079 treatment arms. An unblinded safety review will take place once a minimum of 24 evaluable participants are available for analysis in Part A to decide whether to open enrollment into Part B.
In Part B participants will be randomly assigned to one of two treatment groups. Those who received placebo in this period will have the choice to receive study drug after a safety follow-up period in a single open-label TAK-079 treatment arm.
This multi-center trial will be conducted worldwide. All participants will be followed for at least 8 weeks in a Safety Follow-up Period, and a 16-week Long-term Follow-up Period after the 8 weeks of treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A & B: Double Blind Period: Placebo | Placebo Comparator | Participants received TAK-079 placebo-matching injection subcutaneously (SC), once weekly (QW) for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded short follow-up period (SFP) up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in Open-label Extension (OLE) Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded long follow-up period (LFP) up to Week 32. |
|
| Part A: Double Blind Period: TAK-079 100 mg | Experimental | Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32. |
|
| Part A: Double Blind Period: TAK-079 300 mg | Experimental | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | TAK-079 placebo-matching SC injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (SAE), and TEAEs Leading to TAK-079 Discontinuation | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with the treatment. SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening; c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. TEAEs were defined as an AE having a start date and time equal to or later than the start date and time of the first dose of investigational medicinal product (IMP). Percentages were rounded off to the nearest single decimal place. | Up to Week 32 in each Period of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Platelet Response at Weeks 16 and 32 | Platelet response is defined as a platelet count ≥50,000/microliter (μL) and ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place. | At Weeks 16 and 32 |
Not provided
Inclusion Criteria:
Diagnosed with ITP that has persisted for ≥3 months, diagnosed in accordance to The American Society of Hematology 2011 Evidence-based Practice Guideline for Immune Thrombocytopenia or the International Consensus Report on The Investigation and Management of Primary Immune Thrombocytopenia as locally applicable.
Has a mean platelet count of <30,000/μL (and individually ≤35,000/μL) on at least 2 measurements at least 1 week apart during screening.
Diagnosis of ITP supported by a prior response to an ITP therapy (other than a thrombopoietin receptor agonists [TPO-RA]) that achieved a platelet count of ≥50,000/μL.
If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least 4 weeks before dosing.
Exclusion Criteria:
10 Has had an opportunistic infection ≤12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Research Center - Hunt - PPDS | Tucson | Arizona | 85715 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41950473 | Derived | Kuter DJ, Miura K, Patriarca A, Pulanic D, Radinoff A, Sapunarova K, Syrigou A, Yang R, Nguyen VA, Skelton E, Wang S, Yee DL, Patwari P; Mezagitamab ITP Phase 2 Trial Investigators. A Phase 2 Randomized Trial of Mezagitamab in Primary Immune Thrombocytopenia. N Engl J Med. 2026 Apr 9;394(14):1388-1398. doi: 10.1056/NEJMoa2513120. |
| Label | URL |
|---|---|
| To obtain more information about this study, click this link. | View source |
Not provided
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.
Not provided
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.
Participants who had persistent/chronic primary immune thrombocytopenia (ITP) were randomized to receive either mezagitamab (TAK-079) or matching placebo in Part A or Part B of this study.
Participants took part in the study at 24 investigative sites globally from 09 November 2020 to 29 April 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A & B: Double Blind Period: Placebo | Participants received TAK-079 placebo-matching injection subcutaneously (SC), once weekly (QW) for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded short follow-up period (SFP) up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded long follow-up period (LFP) up to Week 32. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Period (Main Study) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2022 | Apr 23, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part B: Double Blind Period: TAK-079 600 mg | Experimental | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32. |
|
| Part A: Open-label Extension (OLE) Period: TAK-079 100 mg | Experimental | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
|
| Part A: OLE Period: TAK-079 300 mg | Experimental | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
|
| Part B: OLE Period: TAK-079 600 mg | Experimental | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
|
| TAK-079 |
| Drug |
TAK-079 SC injection. |
|
| Percentage of Participants With Complete Platelet Response at Weeks 16 and 32 | Complete platelet response is defined as a platelet count ≥100,000/μL on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place. | At Weeks 16 and 32 |
| Percentage of Participants With Clinically Meaningful Platelet Response at Weeks 16 and 32 | A clinically meaningful platelet response is defined as a platelet count ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place. | At Weeks 16 and 32 |
| Percentage of Participants With Hemostatic Platelet Response at Weeks 16 and 32 | A hemostatic platelet response is defined for participants with a baseline platelet count of <15,000/μL who achieved a platelet count of ≥30,000/μL and ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place. | At Weeks 16 and 32 |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Bleeding and Clotting Disorders Institute | Peoria | Illinois | 61614-3542 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118-2905 | United States |
| Leo W. Jenkins Cancer Center | Greenville | North Carolina | 27834 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda | Sofia | Sofia-Grad | 1407 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sofiamed OOD | Sofia | Sofia-Grad | 1750 | Bulgaria |
| University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD | Pleven | 5800 | Bulgaria |
| University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD | Plovdiv | 4002 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD | Sofia | 1431 | Bulgaria |
| Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia | Sofia | 1606 | Bulgaria |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300020 | China |
| Clinical Hospital Centre Osijek | Osijek | 31000 | Croatia |
| Klinicki bolnicki centar Zagreb | Zagreb | 10000 | Croatia |
| University Hospital Merkur | Zagreb | 10000 | Croatia |
| Universitatsklinikum Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Onkologische Schwerpunktpraxis Kurfurstendamm | Berlin | 10707 | Germany |
| OnkoNet Marburg GmbH | Marburg | 35037 | Germany |
| Rotkreuzklinikum Munchen | München | 80634 | Germany |
| University General Hospital of Patras | Pátrai | Achaia | 26500 | Greece |
| General Hospital of Athens - George Gennimatas | Athens | Attica | 115 27 | Greece |
| Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki | 57010 | Greece |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) | Trieste | Friuli Venezia Giulia | 34149 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi | Catania | Sicily | 95122 | Italy |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| A.O.U. Maggiore della Carita | Novara | 20100 | Italy |
| Azienda Policlinico Umberto I | Roma | 161 | Italy |
| Saiseikai Central Hospital | Minato-Ku | Tokyo | 108-0073 | Japan |
| Nihon University Itabashi Hospital | tabashi City | Tokyo | 173-8610 | Japan |
| Univerzitetni klinicni Center Ljubljana | Ljubljana | 1000 | Slovenia |
| University Clinical Centre Maribor | Maribor | 2000 | Slovenia |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 8208 | Spain |
| Hospital Universitario Principe de Asturias | Meco | Madrid | 28880 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital de La Santa Creu i Sant Pau | Barcelona | 8041 | Spain |
| C.A.U de Burgos - Hospital Universitario de Burgos | Burgos | 9005 | Spain |
| Hospital Universitario Quironsalud Madrid | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28026 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Málaga | 29010 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Municipal Non-profit Enterprise Mykolayiv Regional Clinical Hospital the Mykolayiv Regional Council | Mykolaiv | Mykolaivs'ka Oblast | 54058 | Ukraine |
| Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council | Ternopil | Ternopil Oblast | 46002 | Ukraine |
| MNE Regional Clinical Hospital n a O F Herbachevskyi of Zhytomyr Regional Council | Zhytomyr | Zhytomyr Oblast | 10002 | Ukraine |
| Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS | Dnipro | 49102 | Ukraine |
| Medical Center OK!Clinic+LLC International Institute of Clinical Research | Kyiv | 2091 | Ukraine |
| CNE Kyiv City Clinical Hospital #9 of Exec. Body of Kyiv City Council Kyiv City State Admin | Kyiv | 4060 | Ukraine |
| State Institution Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine | Lviv | 79044 | Ukraine |
| FG001 | Part A: Double Blind Period: TAK-079 100 mg | Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| FG002 | Part A: Double Blind Period: TAK-079 300 mg | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| FG003 | Part B: Double Blind Period: TAK-079 600 mg | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| FG004 | Part A: Open-label Extension (OLE) Period: TAK-079 100 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| FG005 | Part A: OLE Period: TAK-079 300 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| FG006 | Part B: OLE Period: TAK-079 600 mg | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label Extension Period |
|
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A & B: Double Blind Period: Placebo | Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| BG001 | Part A: Double Blind Period: TAK-079 100 mg | Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| BG002 | Part A: Double Blind Period: TAK-079 300 mg | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| BG003 | Part B: Double Blind Period: TAK-079 600 mg | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least One Grade 3 or Higher Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (SAE), and TEAEs Leading to TAK-079 Discontinuation | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with the treatment. SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening; c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. TEAEs were defined as an AE having a start date and time equal to or later than the start date and time of the first dose of investigational medicinal product (IMP). Percentages were rounded off to the nearest single decimal place. | The Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Week 32 in each Period of the study |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Platelet Response at Weeks 16 and 32 | Platelet response is defined as a platelet count ≥50,000/microliter (μL) and ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place. | The Full Analysis Set included all randomized participants who had received at least 1 dose of study drug. Number analyzed indicates the number of participants with data available for analyses at the specified time point. All participants in the 'Part A & B: Double Blind Period: Placebo' arm either transitioned to OLE Period or discontinued from the study prior to Week 32. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 16 and 32 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Platelet Response at Weeks 16 and 32 | Complete platelet response is defined as a platelet count ≥100,000/μL on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place. | The Full Analysis Set consisted of all randomized participants who had received at least 1 dose of study drug. Number analyzed indicates the number of participants with data available for analyses at the specified time point. All participants in the 'Part A & B: Double Blind Period: Placebo' arm either transitioned to OLE Period or discontinued from the study prior to Week 32. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 16 and 32 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Meaningful Platelet Response at Weeks 16 and 32 | A clinically meaningful platelet response is defined as a platelet count ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place. | The Full Analysis Set consisted of all randomized participants who had received at least 1 dose of study drug. Number analyzed indicates the number of participants with data available for analyses at the specified time point. All participants in the 'Part A & B: Double Blind Period: Placebo' arm either transitioned to OLE Period or discontinued from the study prior to Week 32. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 16 and 32 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hemostatic Platelet Response at Weeks 16 and 32 | A hemostatic platelet response is defined for participants with a baseline platelet count of <15,000/μL who achieved a platelet count of ≥30,000/μL and ≥20,000/μL above baseline on at least 2 visits without a dosing period-permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy. Percentages were rounded off to the nearest single decimal place. | The Full Analysis Set included all randomized participants who had received at least 1 dose of study drug. Overall number of participants indicates the number of participants with data available for analyses. Number analyzed indicates the number of participants with data available for analyses at the specified time point. All participants in the 'Part A & B: Double Blind Period: Placebo' arm either transitioned to OLE Period or discontinued from the study prior to Week 32. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 16 and 32 |
|
Up to Week 32 in each Period of the study
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A & B: Double Blind Period: Placebo | Participants received TAK-079 placebo-matching injection SC, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Placebo-assigned participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32. | 0 | 13 | 1 | 13 | 9 | 13 |
| EG001 | Part A: Double Blind Period: TAK-079 100 mg | Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. | 0 | 9 | 2 | 9 | 7 | 9 |
| EG002 | Part A: Double Blind Period: TAK-079 300 mg | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG003 | Part B: Double Blind Period: TAK-079 600 mg | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. | 0 | 11 | 2 | 11 | 6 | 11 |
| EG004 | Part A: Open-label Extension (OLE) Period: TAK-079 100 mg | Participants who received placebo in double-blind Part A and SFP and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. | 0 | 4 | 1 | 4 | 2 | 4 |
| EG005 | Part A: OLE Period: TAK-079 300 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG006 | Part B: OLE Period: TAK-079 600 mg | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. | 0 | 4 | 0 | 4 | 2 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Administration site haematoma | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Optic neuropathy | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Post-traumatic headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2024 | Apr 23, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP.
| OG006 | Part B: OLE Period: TAK-079 600 mg | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| Treatment Emergent SAE |
|
| TEAEs Leading to TAK-079 Discontinuation |
|
| OG002 | Part A: Double Blind Period: TAK-079 300 mg | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| OG003 | Part B: Double Blind Period: TAK-079 600 mg | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| OG004 | Part A: Open-label Extension (OLE) Period: TAK-079 100 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| OG005 | Part A: OLE Period: TAK-079 300 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| OG006 | Part B: OLE Period: TAK-079 600 mg | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
|
|
|
| OG002 | Part A: Double Blind Period: TAK-079 300 mg | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| OG003 | Part B: Double Blind Period: TAK-079 600 mg | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| OG004 | Part A: Open-label Extension (OLE) Period: TAK-079 100 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| OG005 | Part A: OLE Period: TAK-079 300 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| OG006 | Part B: OLE Period: TAK-079 600 mg | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
|
|
|
| OG002 | Part A: Double Blind Period: TAK-079 300 mg | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| OG003 | Part B: Double Blind Period: TAK-079 600 mg | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| OG004 | Part A: Open-label Extension (OLE) Period: TAK-079 100 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| OG005 | Part A: OLE Period: TAK-079 300 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| OG006 | Part B: OLE Period: TAK-079 600 mg | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
|
|
|
Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32.
| OG002 | Part A: Double Blind Period: TAK-079 300 mg | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| OG003 | Part B: Double Blind Period: TAK-079 600 mg | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants were then followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| OG004 | Part A: Open-label Extension (OLE) Period: TAK-079 100 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| OG005 | Part A: OLE Period: TAK-079 300 mg | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| OG006 | Part B: OLE Period: TAK-079 600 mg | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
|
|
|
|
|
|
|