Study to Evaluate Safety Tolerability and Efficacy of TAK-079 in Participants With Persistent/Chronic Primary Immune Thrombocytopenia

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    54
  • sponsor
    Millennium Pharmaceuticals, Inc.
Updated on 27 January 2021

Summary

The purpose of this study is to evaluate the safety and tolerability of TAK-079 in participants with persistent/chronic primary immune thrombocytopenia (ITP).

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 54 patients. 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 study drug after a safety follow-up period and will be randomized to one of the two open-label TAK-079 treatment arms.

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 after the 8 weeks of treatment.

Details
Condition Primary Immune Thrombocytopenia
Treatment Placebo, TAK-079
Clinical Study IdentifierNCT04278924
SponsorMillennium Pharmaceuticals, Inc.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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/L (and individually 35,000/L) 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/L
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

Exclusion Criteria

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 patient'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 minute (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 CD19 counts within the normal range at screening
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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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