Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05755035 · ClinicalTrials.gov registry record · Phase 2
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT05755035: Completed Phase 2 study, sponsored by Takeda.
NCT05755035 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05755035, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL TAK-881
- BIOLOGICAL HYQVIA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-10-24 |
| Est. Completion | 2026-01-20 |
| Phase | Phase 2 |
What the finished NCT05755035 record still lists
NCT05755035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which TAK-881 is the first listed.
NCT05755035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05755035 about?
NCT05755035 is a clinical study titled "A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases". 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/HYQ...
What is the current status of trial NCT05755035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2023-10-24. Estimated completion is 2026-01-20.
What interventions are being tested in trial NCT05755035?
The interventions under investigation include: TAK-881 (BIOLOGICAL), HYQVIA (BIOLOGICAL).
Who is sponsoring clinical trial NCT05755035?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05755035's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03366116 · 65 participants · Phase 1
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
- NCT03603730 · 65 participants · NA
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
- NCT03796559 · 65 participants · NA
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
- NCT03993106 · 65 participants · Phase 2
A Study of sEphB4-HSA in Kaposi Sarcoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI