A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
Sponsored by Takeda
About this trial
Last updated a month ago
Study ID
TAK-881-3001
Status
Active, not recruiting
Type
Interventional
Phase
Phase 2/Phase 3
Placebo
No
Accepting
2+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 2 years ago
What is this trial about?
The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity
of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with
PIDD and compare them to HYQVIA in participants 16 years old and older.
The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose
and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than
or equal to [>=]16 years) and only with TAK-881 for up to 27 weeks (for participants aged
2 to less than [<]16 years) as they were treated with another immunoglobulin before
enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the
duration of the study.
What are the participation requirements?
Inclusion Criteria
Must be 2 years or older at the time of screening.
Must have been diagnosed with primary humoral immunodeficiency.
Must have received regular IVIG or HYQVIA over a period of at least 12 weeks prior to screening.
Must have serum trough level of immunoglobulin (IgG) more than (>) 5 grams per liter (g/L) at least 1 documented time within 12 weeks prior to screening and at screening.
Additional entry criteria will be discussed with the study doctor.
For more information, view the full study details:
NCT05755035