A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
Key facts
- Who runs it
- Takeda
- Where
- Boston, Charlottesville, Gainesville, Greenville, Peoria, and Tucson, United StatesSee the 7 sitesAlso in 10 other countries, 48 sites
- Trial code
- NCT04278924
- EudraCT 2019-004103-12
- JRCT2031220408
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 41 people enrolled
- Started
- 9 Nov 2020
- Ended
- 29 Apr 2024
- Type of study
- Interventional, 7 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- TAK-079
- Record updated
- 15 June 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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 take part
- 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
- Use of immunosuppressants (such as cyclophosphamide, vincristine) other than permitted oral immunosuppressants within 6 months before first dosing
- 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
- Diagnosed with chronic obstructive pulmonary disease (COPD) or asthma, and a prebronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal
- Has been diagnosed with myelodysplastic syndrome
- 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
Where in United States
Also in 10 other countries, 48 sites
- Boston Medical CenterBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- University of FloridaGainesville, United StatesNo longer taking part
- Leo W Jenkins Cancer CenterGreenville, United StatesNo longer taking part
- Bleeding and Clotting Disorders InstitutePeoria, United StatesNo longer taking part
- Arizona Clinical Research Center - Hunt - PPDSTucson, United StatesNo longer taking part
About the trial
What the trial wants to find out
Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot.
Read full original descriptionShow less
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 7 groups in the trial
- Part A & B: Double Blind Period: PlaceboPlacebo, for comparison
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.
Treatment: Placebo
- Part A: Double Blind Period: TAK-079 100 mgTreatment being tested
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.
Treatment: TAK-079
- Part A: Double Blind Period: TAK-079 300 mgTreatment being tested
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.
Treatment: TAK-079
- Part B: Double Blind Period: TAK-079 600 mgTreatment being tested
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.
Treatment: TAK-079
- Part A: Open-label Extension (OLE) Period: TAK-079 100 mgTreatment being tested
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.
Treatment: TAK-079
- Part A: OLE Period: TAK-079 300 mgTreatment being tested
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.
Treatment: TAK-079
- Part B: OLE Period: TAK-079 600 mgTreatment being tested
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: TAK-079
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Publications
- A Phase 2 Randomized Trial of Mezagitamab in Primary Immune Thrombocytopenia.The New England journal of medicine, 2026
- Record updated
- 15 June 2025