← Back to Search

Immunoglobulin Replacement Therapy

TAK-881 for Primary Immunodeficiency

Phase 3

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

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

Must have

Must not have

Female participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 13 up to week 121

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

"This trial aims to determine if TAK-881 is safe for long-term use in adults and children with Primary Immunodeficiency Disorder who completed a previous study. Participants will receive TAK-881 inf

Who is the study for?

This trial is for adults and children with Primary Immunodeficiency Diseases (PIDD) who completed the TAK-881-3001 study. Participants must agree to use contraception if applicable, have a negative pregnancy test if female of childbearing potential, and be willing to follow the study procedures.

What is being tested?

The safety and tolerance of long-term use of TAK-881 are being tested in this trial. Patients will start with the same dose they ended on in a previous study and can adjust dosage or interval between doses every 2, 3, or 4 weeks as directed by their doctor.

What are the potential side effects?

Specific side effects are not listed here; however, since TAK-881 is an immunoglobulin infusion therapy, common side effects may include injection site reactions, headache, fatigue, fever, nausea or allergic reactions.

Eligibility Criteria

Exclusion Criteria

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

Select...

I am not pregnant or breastfeeding and do not plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 13 up to week 121

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 13 up to week 121

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 13 up to week 121 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Health-Related Quality of Life (HRQoL): EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Score in Participants Aged >=12 Years

Number of Participants who have Infusions of TAK-881 at Physical Location

Treatment Preference Measured by a Disease-specific Questionnaire for Participants and the Investigational Medical Device Using TAK-881 in Participants Aged >=12 Years

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TAK-881Experimental Treatment2 Interventions

Epoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 subcutaneous (SC) infusion using investigational needle sets at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002. Epoch 2: Participants with anti-rHuPH20 antibody titer \>=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121. After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-881

2021

Completed Phase 1

~30

0 / 1Eligibility criteria met