TAK-881 vs HYQVIA for CIDP

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Must be taking: IGIV, cIGSC, HYQVIA

Must not be taking: Immunosuppressives, Chemotherapy, Corticosteroids

Disqualifiers: Focal CIDP, Hereditary neuropathies, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

59 Participants Needed

Trial Summary

What is the purpose of this trial?

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 24 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.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for adults with CIDP who have had a positive response to IgG treatments. They must be on a stable dose of IGIV, cIGSC, or HYQVIA and meet specific disability score criteria. Participants should understand the trial procedures and agree to follow them, including using contraception if they can become pregnant.

Inclusion Criteria

My disability score is 2, due to issues with my legs.

I have signed the consent form for this trial.

My disability score is 2, not just from my legs, and was 2 or higher before screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Ramp-up

Participants on IGIV or cIGSC switch to HYQVIA with gradually increasing doses/volumes

1-2 weeks

HYQVIA Treatment

Participants receive HYQVIA treatment for maintenance therapy

18-20 weeks

Visits every 3 or 4 weeks

TAK-881 Treatment

Participants switch to TAK-881 with a 1:1 dose conversion

24 weeks

Visits every 3 or 4 weeks

Extension

Participants continue TAK-881 treatment with home infusions allowed

Up to 3 years

Visits every 12 to 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HYQVIA
• TAK-881

Trial Overview The study compares TAK-881 and HYQVIA in their effectiveness as maintenance therapy for CIDP when administered subcutaneously. Patients will switch from their current IgG treatment to HYQVIA for 24 weeks, then to TAK-881 for another 24 weeks, with clinic visits every few weeks before home infusions start.

Participant Groups

Group I: All Participants (HYQVIA and TAK-881) Experimental Treatment 3 Interventions

Ramp-up Epoch: Participants on IGIV or cIGSC will switch to HYQVIA during ramp-up epoch with gradually increasing doses/volumes. For participants switching from IGIV, first HYQVIA dose is given two weeks after their last IGIV infusion. For participants switching from cIGSC, first dose is given one week after a weekly infusion or two weeks after a bi-weekly infusion, using a SC investigational needle set. Treatment Epoch: After completing ramp-up, participants will enter HYQVIA dosing epoch 2-3 weeks later, depending on treatment interval. Those already on HYQVIA at screening will skip ramp-up and proceed directly to dosing phase, lasting 18 weeks for a 3-week interval and 20 weeks for 4-week interval. After HYQVIA PK sampling period, participants will switch to TAK-881 with a 1:1 dose conversion. TAK-881 dosing lasts 24 weeks with a SC infusion needle set. Extension Epoch: Post-TAK-881, participants will enter the extension epoch, continuing treatment for up to 3 years.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials

58

Recruited

10,800+