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TAK-079 for Primary Immune Thrombocytopenia

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

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

Use of immunosuppressants (such as cyclophosphamide, vincristine) other than permitted oral immunosuppressants within 6 months before first dosing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 32

Summary

This trial is testing TAK-079, a new drug, to see if it can help people with primary immune thrombocytopenia (ITP) by increasing their platelet counts. The study will check for side effects and effectiveness of TAK-079. Participants will receive either the drug or their usual treatment.

Who is the study for?

Adults with persistent or chronic primary immune thrombocytopenia (ITP) who have low platelet counts and have been on a stable ITP treatment for at least 4 weeks. They must not be taking certain medications like anticoagulants, antiplatelets, or recent monoclonal antibodies and should not have had a splenectomy within the last 3 months.

What is being tested?

The trial is testing TAK-079's safety and effectiveness in increasing platelet counts compared to a placebo. Participants will receive weekly injections of either TAK-079 or placebo alongside their current ITP treatments for two months, followed by additional follow-up periods.

What are the potential side effects?

Potential side effects of TAK-079 are not specified but may include reactions at the injection site, general discomfort, or other immune-related effects due to its nature as an immunomodulating agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with ITP for 3 months or more.

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I have ITP and responded to treatment before, reaching a platelet count of 50,000 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a serious infection or am being treated for one like TB in the last 3 months.

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I haven't taken certain strong immune system drugs in the last 6 months.

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I haven't taken blood thinners or aspirin in the last 3 weeks.

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I haven't used any immunoglobulin treatments in the last 4 weeks.

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I have COPD or asthma with severe breathing test results.

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I have been diagnosed with myelodysplastic syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 32 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percentage of Participants with Clinically Meaningful Platelet Response

Percentage of Participants with Complete Platelet Response

Percentage of Participants with Hemostatic Platelet Response

+1 more

Side effects data

From 2022 Phase 2 trial • 36 Patients • NCT04159805

17%

Pyrexia

Depression

Diplopia

Suicidal ideation

Atrioventricular block first degree

Malaise

Conjunctivitis allergic

Dysarthria

Dyspnoea exertional

Fatigue

Injection site pain

Muscular weakness

Paraesthesia

Influenza like illness

Lymphocyte count decreased

Myasthenia gravis

Parosmia

Periorbital oedema

Visual impairment

100%

80%

60%

40%

20%

Study treatment Arm

TAK-079 Placebo-matching

TAK-079 300 mg

TAK-079 600 mg

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: OLE Phase, TAK-079 Dose 3Experimental Treatment1 Intervention

Participants who received placebo in double-blind Part B and opt to receive further treatment will receive TAK-079 Dose 3, SC injection QW for 8 weeks in OLE Phase of Part B.

Group II: Part B: Double Blind, TAK-079 Dose 3Experimental Treatment1 Intervention

TAK-079 Dose 3, SC injection QW for 8 weeks.

Group III: Part A: Open-label Extension (OLE) Phase, TAK-079 Dose 1Experimental Treatment1 Intervention

Participants who received placebo in double-blind Part A and opt to receive further treatment will be randomized to receive TAK-079 Dose 1, SC injection QW for 8 weeks in OLE Phase of Part A.

Group IV: Part A: OLE Phase, TAK-079 Dose 2Experimental Treatment1 Intervention

Participants who received placebo in double-blind Part A and opt to receive further treatment will be randomized to receive TAK-079 Dose 2, SC injection QW for 8 weeks in OLE Phase of Part A.

Group V: Part A: Double Blind, TAK-079 Dose 2Experimental Treatment1 Intervention

TAK-079 Dose 2, SC injection QW for 8 weeks.

Group VI: Part A: Double Blind, TAK-079 Dose 1Experimental Treatment1 Intervention

TAK-079 Dose 1, SC injection QW for 8 weeks.

Group VII: Part B: Double Blind, PlaceboPlacebo Group1 Intervention

TAK-079 placebo-matching injection SC, QW for 8 weeks.

Group VIII: Part A: Double Blind, PlaceboPlacebo Group1 Intervention

TAK-079 placebo-matching injection subcutaneously (SC) once weekly (QW) for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug