NCT06747351

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to evaluate the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA subcutaneous (SC) administration for maintenance therapy of CIDP. The participants who are already receiving intravenous immunoglobulin G (IGIV), conventional subcutaneous intravenous immunoglobulin G (cIGSC), or HYQVIA will be treated with the same dose equivalent as their prior IG treatment with HYQVIA for 20 weeks followed by TAK-881 for 24 weeks. Participants will need to visit the clinic every 3 or 4 weeks until they enter the extension phase. In the extension phase, home infusions are allowed, and visits will occur between every 12 weeks and 24 weeks.

Detailed description

The study includes a screening phase, a ramp-up phase (if needed), a HYQVIA treatment phase, a TAK-881 treatment phase, and an extension phase. Participants who have been receiving cIGSC or IGIV prior to the study will enter a HYQVIA ramp-up phase, starting 1 to 2 weeks after their last pre-study cIGSC or IGIV dose. Participants already on HYQVIA at the time of screening will proceed directly to the treatment phase. After the TAK-881 dosing phase, participants will move on to the TAK-881 extension phase, with the preference for subsequent infusions in the extension phase to be administered by the participant or caregiver at home.

Conditions

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Interventions

Type	Name	Description
BIOLOGICAL	TAK-881	Participants will receive SC infusion of TAK-881.
BIOLOGICAL	HYQVIA	Participants will receive SC infusion of HYQVIA.
DEVICE	SC Investigational Needle Sets	The single-use only SC needle set will be used to administer TAK-881/HYQVIA to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.

Timeline

• Start date: 2025-05-06
• Primary completion: 2028-06-25
• Completion: 2028-06-25
• First posted: 2024-12-24
• Last updated: 2026-01-20

Locations

52 sites across 11 countries: United States, Argentina, Czechia, Denmark, Germany, Greece, Italy, Japan, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study
• FDA-regulated device study