Phase 3
N=15
A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
Primary Immunodeficiency Diseases (PID)
Bottom Line
View on ClinicalTrials.gov: NCT05513586 ↗Enrolled (actual)
15
Serious AEs
40.0%
Results posted
May 2026
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TAK-771 (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Oct 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
100 | — |
| PRIMARY Percentage of Participants Who Developed Anti-rHuPH20 Binding Antibody Titers of >=1:160 and Neutralizing Antibodies to rHuPH20 |
0; 0 | — |
Summary
The main aim of the study is to check side effect from the study treatment with TAK-771 in long term.
Participants can have taken part in the previous study TAK-771-3004 (NCT05150340). For those who can take part, the participants will receive injections of TAK-771 after the end of the previous study. The participants will be treated with TAK-771 for totally 3 years.
There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug.
Eligibility Criteria
Inclusion Criteria
- Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340).
- Written and/or electronic informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration. If a participant is <18 years of age, written and/or electronic informed consent should also be obtained from the participant's legally authorized representative in addition to written informed assent by a participant if appropriate.
- Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria
- Participant has developed a new serious medical condition during Study TAK-771-3004 such that the participant's safety or medical care would be impacted by participation in the study.
- Participant is willing to participate in other clinical trials.
- Women of childbearing potential who meet any one of the following criteria:
- Participant presents with a positive pregnancy test.
- Participant does not agree to employ adequate birth-control measures (eg, intrauterine device, condom [for male partner], or birth-control pills) throughout the course of the study.
Data sourced from ClinicalTrials.gov (NCT05513586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.