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

StatusCompleted
PhasePhase 2/3
SponsorTakeda
Started

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Record History

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  1. Results posted: Sep 30, 2026 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints revised (36)
    • Study description revised
    • Site details revised at 3 of 32 sites
  2. Primary endpoint revised
    • Secondary endpoints: 35 to 36
    v11
  3. Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Feb 10, 2026 to Jan 20, 2026
    • Study completion date changed from estimate of Sep 30, 2026 to Jan 20, 2026
    v10
  4. Re-verified, no change to tracked fieldsv9
  5. Study sites: 41 to 32
    • Eligibility criteria expanded, about 18 words
    v8
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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 75 to confirmed 65
    • Site details revised at 41 of 41 sites
    v7
  2. Study sites: 5 to 41v6
  3. Enrollment target: 71 to 75
    • Eligibility criteria expanded, about 275 words
    • Secondary endpoints revised (35)
    • Study description expanded, about 7 words
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Oct 30, 2023 to Oct 24, 2023
    v4
  5. Primary completion date: Apr 28, 2025 to Feb 10, 2026v3 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 61 to 71
    • Study completion date: Apr 28, 2025 to Sep 30, 2026
    • Start date: Oct 1, 2023 to Oct 30, 2023
    • Eligibility criteria shortened, about 97 words
    • Secondary endpoints: 19 to 35
    • Study title expanded, about 8 words
    • Study description expanded, about 2 words
  6. Start date: Mar 29, 2023 to Oct 1, 2023v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Takeda
222 trials monitored
See 14 trials at risk
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.
Trial Details
NCT Number NCT05755035
Lead Sponsor Takeda
Collaborators: Takeda Development Center Americas, Inc.
Conditions
(from sponsor)		 Primary Immunodeficiency Diseases (PID)
Related terms Primary Immunodeficiency Diseases
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov