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Immunoglobulin

Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1) 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 28 weeks (2 to <16 years) and 52 weeks (>=16 years)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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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 28 weeks (2 to <16 years) and 52 weeks (>=16 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 weeks (2 to <16 years) and 52 weeks (>=16 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 weeks (2 to <16 years) and 52 weeks (>=16 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) of total IgG with TAK-881 and HYQVIA in Participants Aged >=16 Years with PIDD

Secondary outcome measures

AUC0-tau; ss Per Week (AUC0-tau; ss/week) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD

AUC0-tau; ss Per Week (AUC0-tau; ss/week) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 years with PIDD

Annualized Rate of Acute Serious Bacterial Infections (ASBIs) in Participants

+32 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Takeda Development Center Americas, Inc.Industry Sponsor

56 Previous Clinical Trials

11,959 Total Patients Enrolled

TakedaLead Sponsor

1,203 Previous Clinical Trials

4,177,869 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,211 Previous Clinical Trials

489,197 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in the clinical trial?

"This trial requires 71 qualified participants. Those living in the vicinity of Central Georgia Infectious disease Consultants (Macon, GA) and Tanner Clinic (Murray, UT) are encouraged to consider volunteering for this study."

Answered by AI

Are there any ongoing recruitment initiatives for this research project?

"Affirmative. According to the information visible on clinicaltrials.gov, this medical study began searching for participants on October 24th 2023 and was last modified on December 14th 2023. Presently, 71 patients are being sought from 5 different locations."

Answered by AI

Are there multiple medical centers in Canada conducting this research experiment?

"There are 5 approved locations recruiting for this trial, such as Central Georgia Infectious disease Consultants in Macon and Tanner Clinic in Murray. Additionally, Sneeze, Wheeze & Itch Associates LLC is running the study out of Normal with other sites scattered around the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

2023. "A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05755035.

All > Primary Immunodeficiency