Primary Immune ThrombocytopeniaPhase 2NCT04278924
A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
A Phase 2 study testing TAK-079 in people with Primary Immune Thrombocytopenia, run by Takeda at 55 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- TAK-079
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 55 sitesin 11 countries
- Study dates
- 9 Nov 2020to 29 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Permitted standard background treatments may include: 1 oral corticosteroid; ±1 immunosuppressant from the following list: azathioprine, danazol, dapsone, cyclosporine, mycophenolate mofetil, mycophenolate sodium; ±1 TPO-RA (romiplostim, eltrombopag, avatrombopag); ±fostamatinib. Corticosteroids, including dexamethasone, must be given as oral, daily or every-other-day therapy as opposed to pulse therapy.
- The dose of any permitted standard background therapy must be expected to remain stable through the study, unless dose reduction is required because of toxicities.
Who cannot join
- Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within 3 weeks before screening.
- Has a history of any thrombotic or embolic event within 12 months before screening.
- Has a history of splenectomy within 3 months before screening.
- Use of intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin or anti-D immunoglobulin treatment within 4 weeks of screening, or an expectation that any therapy besides the participant's standard background therapies may be used for treatment of thrombocytopenia (e.g., a rescue therapy) between screening and dosing.
- Diagnosed with chronic obstructive pulmonary disease (COPD) or asthma, and a prebronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal.
- Use of rituximab or any monoclonal antibody (mAb) for immunomodulation within 4 months before first dosing. Note: Participants with prior exposure to rituximab must have cluster of differentiation (CD) 19 counts within the normal range at screening.
Show all 10Show fewer
- Use of immunosuppressants (such as cyclophosphamide, vincristine) other than permitted oral immunosuppressants within 6 months before first dosing.
- Has been diagnosed with myelodysplastic syndrome.
- Has received a live vaccine within 4 weeks before screening or has any live vaccine planned during the study.
- 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.
Trial locations and contacts
55 sites in 11 countries.
55 sites in 11 countries
Spain12 sites
Hospital del Mar
Barcelona, 08003
Hospital de La Santa Creu i Sant Pau
Barcelona, 8041
C.A.U de Burgos - Hospital Universitario de Burgos
Burgos, 9005
Hospital Universitario Quironsalud Madrid
Madrid, 28006
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28026
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Virgen del Rocio - PPDS
Málaga, 29010
Hospital Universitario Principe de Asturias
Meco, Madrid, 28880
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 8208
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118-2905
University of Virginia
Charlottesville, Virginia, 22903
University of Florida
Gainesville, Florida, 32610
Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834
Bleeding and Clotting Disorders Institute
Peoria, Illinois, 61614-3542
Arizona Clinical Research Center - Hunt - PPDS
Tucson, Arizona, 85715
Italy7 sites
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, 40138
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania, Sicily, 95122
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
A.O.U. Maggiore della Carita
Novara, 20100
Azienda Policlinico Umberto I
Roma, 161
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
Trieste, Friuli Venezia Giulia, 34149
Ukraine7 sites
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
Dnipro, 49102
Medical Center OK!Clinic+LLC International Institute of Clinical Research
Kyiv, 2091
CNE Kyiv City Clinical Hospital #9 of Exec. Body of Kyiv City Council Kyiv City State Admin
Kyiv, 4060
State Institution Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine
Lviv, 79044
Municipal Non-profit Enterprise Mykolayiv Regional Clinical Hospital the Mykolayiv Regional Council
Mykolaiv, Mykolaivs'ka Oblast, 54058
Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council
Ternopil, Ternopil Oblast, 46002
MNE Regional Clinical Hospital n a O F Herbachevskyi of Zhytomyr Regional Council
Zhytomyr, Zhytomyr Oblast, 10002
Bulgaria6 sites
University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
Pleven, 5800
University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
Sofia, Sofia-Grad, 1407
University Multiprofile Hospital for Active Treatment Sofiamed OOD
Sofia, Sofia-Grad, 1750
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia, 1431
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, 1606
Germany4 sites
Onkologische Schwerpunktpraxis Kurfurstendamm
Berlin, 10707
Universitatsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
OnkoNet Marburg GmbH
Marburg, 35037
Rotkreuzklinikum Munchen
München, 80634
Croatia3 sites
Clinical Hospital Centre Osijek
Osijek, 31000
Klinicki bolnicki centar Zagreb
Zagreb, 10000
University Hospital Merkur
Zagreb, 10000
Greece3 sites
General Hospital of Athens - George Gennimatas
Athens, Attica, 115 27
University General Hospital of Patras
Pátrai, Achaia, 26500
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 57010
China2 sites
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Japan2 sites
Saiseikai Central Hospital
Minato-Ku, Tokyo, 108-0073
Nihon University Itabashi Hospital
tabashi City, Tokyo, 173-8610
Slovenia2 sites
Univerzitetni klinicni Center Ljubljana
Ljubljana, 1000
University Clinical Centre Maribor
Maribor, 2000
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Persistent/Chronic Primary Immune Thrombocytopenia
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- Placebo, TAK-079
- Keywords
- Drug Therapy
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
TAK-079 placebo-matching SC injection.
TAK-079Drug
TAK-079 SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo |
| 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. Receives: Drug: TAK-079 |
| 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. Receives: Drug: TAK-079 |
| 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. Receives: Drug: TAK-079 |
| 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. Receives: Drug: TAK-079 |
| 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. Receives: Drug: TAK-079 |
| 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. Receives: Drug: TAK-079 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 32 in each Period of the study
Secondary outcomes (4)
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.
Measured: At Weeks 16 and 32
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.
Measured: 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.
Measured: 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.
Measured: At Weeks 16 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start9 Nov 2020
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278924
- Sponsor's protocol ID
- TAK-079-1004
- Other IDs
- 2019-004103-12, jRCT2031220408, 2019
- Status last verified
- May 2025
- First submitted
- 19 Feb 2020
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41950473
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Persistent/Chronic Primary Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT04278924
- Acronym / sponsor ID
- TAK-079-1004
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A & B: Double Blind Period: Placebo | Placebo comparator | Drug: PlaceboParticipants 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 | Drug: TAK-079Participants 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 | Drug: TAK-079Participants 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. |
| Part B: Double Blind Period: TAK-079 600 mg | Experimental | Drug: TAK-079Participants 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 | Drug: TAK-079Participants 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 | Drug: TAK-079Participants 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 | Drug: TAK-079Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within 3 weeks before screening.
- Has a history of any thrombotic or embolic event within 12 months before screening.
- Has a history of splenectomy within 3 months before screening.
- Use of intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin or anti-D immunoglobulin treatment within 4 weeks of screening, or an expectation that any therapy besides the participant's standard background therapies may be used for treatment of thrombocytopenia (e.g., a rescue therapy) between screening and dosing.
- Diagnosed with chronic obstructive pulmonary disease (COPD) or asthma, and a prebronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTAK-079 placebo-matching SC injection. | Drug | Part A & B: Double Blind Period: Placebo |
| TAK-079TAK-079 SC injection. | Drug | Part A: Double Blind Period: TAK-079 100 mg, Part A: Double Blind Period: TAK-079 300 mg, Part A: OLE Period: TAK-079 300 mg, Part A: Open-label Extension (OLE) Period: TAK-079 100 mg, Part B: Double Blind Period: TAK-079 600 mg, Part B: OLE Period: TAK-079 600 mg |
Primary outcome
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
Time frame: Up to Week 32 in each Period of the study
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.
4 secondary outcomes
Percentage of Participants With Platelet Response at Weeks 16 and 32
Time frame: At Weeks 16 and 32
Percentage of Participants With Complete Platelet Response at Weeks 16 and 32
Time frame: At Weeks 16 and 32
Percentage of Participants With Clinically Meaningful Platelet Response at Weeks 16 and 32
Time frame: At Weeks 16 and 32
Percentage of Participants With Hemostatic Platelet Response at Weeks 16 and 32
Time frame: At Weeks 16 and 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41950473Kuter 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.
- To obtain more information about this study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
55 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-079 in people with Primary Immune Thrombocytopenia, run by Takeda at 55 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in Spain, United States, Italy, Ukraine, Bulgaria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to Week 32 in each Period of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.