A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia - /

MILLENNIUM PHARMACEUTICALS, INC.0 sites54 target enrollmentJanuary 21, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: MILLENNIUM PHARMACEUTICALS, INC.
Enrollment: 54
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 21, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MILLENNIUM PHARMACEUTICALS, INC.

Eligibility Criteria

Inclusion Criteria

•Each patient must meet all the following inclusion criteria to be to be randomized to treatment:
•1\. Age 18 years or older and able and willing to comply with study procedures.
•2\. 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.
•3\. Presents with a mean platelet count of \<30,000/µL for the 4 weeks before the first study dose. The mean platelet count is based on at least 2 platelet counts within 4 weeks of dosing, including the value obtained at screening. No individual platelet count \>35,000/µL during these times is allowed.
•4\. Has had 1 prior platelet response to any standard of care treatment to achieve a platelet count of \=50,000/µL. Any standard treatment in this context may include therapies that are not
•permitted concomitant therapies during the study.
•5\. If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least 4 weeks before dosing.
•a) 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 therapy as opposed to pulse therapy. High\-dose pulse steroid therapy is not
•allowed within 14 days before Day 1\.
•b) 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

•Patients meeting any of the following exclusion criteria are not to be randomized to treatment:
•1\. Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within 3 weeks before screening.
•2\. History of any thrombotic or embolic event within 12 months before screening.
•3\. History of splenectomy within 3 months before screening.
•4\. Use of IVIg, subcutaneous immunoglobulin or anti\-D treatment within 4 weeks of screening.
•5\. Diagnosed with chronic obstructive pulmonary disease (COPD) or asthma, and a prebronchodilatory forced expiratory volume in 1 second (FEV1\) \<50% of predicted normal.
•Note: FEV1 testing is required for patients suspected of having COPD or asthma.
•6\. Use of rituximab or any mAb for immunomodulation within 4 months before first dosing.
•Note: Patients with prior exposure to rituximab must have CD19 counts within the normal range at screening.
•7\. Use of immunosuppressants (such as cyclophosphamide, vincristine) other than permitted oral immunosuppressants within 6 months before first dosing.