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Immunoglobulin

TAK-881 for Primary Immunodeficiency

Phase 2 & 3

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

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

Must have

Participant must have a documented diagnosis of a form of primary humoral immunodeficiency involving a defect in antibody formation and requiring immunoglobulin (IgG) replacement, as defined according to the International Union of Immunological Societies (IUIS) Committee.

Participant is 2 years to <16 years at the time of screening for the nonrandomized part of the study OR 16 years or older at the time of screening for the randomized crossover part of the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety, effectiveness, and side effects of TAK-881 compared to HYQVIA for PIDD. Participants will need to visit the clinic every 3-4 weeks for up to 51 weeks.

Who is the study for?

This trial is for children and adults with Primary Immunodeficiency Diseases (PIDD) who need regular immune globulin treatments. Participants aged 2-15 will only receive TAK-881, while those 16+ may also get HYQVIA. They must have been on a stable dose of immunoglobulin therapy prior to the study and be willing to follow the study procedures.

What is being tested?

The trial is testing how TAK-881, given under the skin, compares to HYQVIA in treating PIDD. It looks at how the body processes these drugs, their safety, tolerability, and potential immune response over up to 51 weeks for adults and up to 27 weeks for kids.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain or swelling, headache, fatigue, nausea or vomiting. There's also a chance of developing antibodies against TAK-881 which could reduce its effectiveness.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a diagnosed immune system disorder that affects my body's ability to produce antibodies, requiring me to receive immunoglobulin (IgG) replacement.

Select...

I am either 2-15 years old for the nonrandomized part or 16+ for the randomized part.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Single Arm Treatment Epoch: TAK-881Experimental Treatment1 Intervention

Pediatric participants aged 2 to \<16 years will receive 6 or 8 infusions at full doses of TAK-881. The first full dose of TAK-881, will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their prestudy IgG treatment (applicable for participants pre-treated with HYQVIA).

Group II: Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1)Experimental Treatment2 Interventions

Participants aged \>=16 years will receive 6 or 8 infusions at full doses of TAK-881 followed by HYQVIA in sequence 1. The first full dose of TAK-881 will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study immunoglobulin G (IgG) treatment (applicable for participants pre-treated with HYQVIA).

Group III: Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2)Experimental Treatment2 Interventions

Participants aged \>=16 years will receive 6 or 8 infusions at full doses of HYQVIA followed by TAK-881 in Sequence 2. The first full dose of HYQVIA will be administered either 2 weeks after the second ramp-up dose (applicable for participants pretreated with IGIV or cIGSC) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (applicable for participants pre-treated with HYQVIA).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-881

2021

Completed Phase 1

~30

HYQVIA

2016

Completed Phase 4

~630