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NCT06747351RECRUITINGanonymous

A Phase 3, Single-Arm, Multiple-Dose, Pharmacokinetic Comparability Trial Between TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Sponsor

Source record

Takeda

Phase

Source record

Phase 3

Modality

AI-normalized

protein therapy

Target

AI-normalized

Immunoglobulin G (IgG) levels modulation via subcutaneous administration of TAK-881 and HYQVIA for the treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).

Indication / condition

AI-normalized

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Intervention

Source record

TAK-881, HYQVIA, SC Investigational Needle Sets

Source & freshness

Source record

NCT ID

NCT06747351

Original source

ClinicalTrials.gov

Source last updated

Jan 20, 2026

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT06747351

Title

A Phase 3, Single-Arm, Multiple-Dose, Pharmacokinetic Comparability Trial Between TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Sponsor

Takeda

Status

RECRUITING

Phase

Phase 3

Condition raw

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Condition normalized

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Modality raw

protein therapy

Modality normalized

protein therapy

Target raw

Immunoglobulin G (IgG) levels modulation via subcutaneous administration of TAK-881 and HYQVIA for the treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).

Target normalized

Immunoglobulin G (IgG) levels modulation via subcutaneous administration of TAK-881 and HYQVIA for the treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).

Interventions

TAK-881, HYQVIA, SC Investigational Needle Sets

Public preview

Source record

Takeda's Phase 3 trial of TAK-881 aims to establish pharmacokinetic comparability with HYQVIA, a current treatment for CIDP. The trial's design allows for a direct comparison of two subcutaneous immunoglobulin therapies, potentially positioning TAK-881 as a competitive alternative in the CIDP market. Given the increasing prevalence of CIDP and the growing demand for effective therapies, successful outcomes could enhance Takeda's market share in the immunoglobulin therapy sector. The trial's recruitment status is currently active, with an estimated enrollment of 59 participants, indicating a focused approach to gathering robust data. The competitive landscape includes existing therapies like HYQVIA and other immunoglobulin products, necessitating a thorough analysis of efficacy and safety profiles to ensure differentiation.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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