TAK-881 vs HYQVIA for CIDP

Recruiting at 51 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, TAK-881 and HYQVIA (an immunoglobulin therapy), to evaluate their effectiveness when administered subcutaneously to individuals with CIDP, a condition causing nerve damage and muscle weakness. The goal is to understand how the body absorbs and processes these treatments. Participants who have used certain immunoglobulin therapies and responded well to past treatments are ideal candidates, especially if they experience symptoms like muscle weakness and numbness due to CIDP. Participants will switch from their current treatment to HYQVIA first, then to TAK-881, with clinic visits every few weeks initially, and later, home infusions may be possible. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for CIDP.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you continue your existing immunoglobulin treatment (IGIV, cIGSC, or HYQVIA) at the same dose. If you are taking other immunomodulatory or immunosuppressive medications, you may need to stop them if they were taken within 6 months of screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that HYQVIA is safe for treating CIDP. The FDA has approved it for this condition, indicating it has undergone thorough testing. Long-term studies suggest it is safe and generally well-tolerated, with a low chance of symptoms returning and manageable side effects.

For TAK-881, early research in healthy adults shows it is well-tolerated and appears safe. However, it is still under study specifically for CIDP, so ongoing research will provide more information to confirm its safety for this use.

Both treatments are administered through subcutaneous infusions and include safety monitoring protocols. Participants have experienced few serious side effects, but it is important to watch for any reactions and report them to the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TAK-881 and HYQVIA for treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) because these treatments offer a unique approach compared to traditional therapies. Unlike standard intravenous immunoglobulin (IVIG) treatments, HYQVIA combines immunoglobulin with recombinant human hyaluronidase, allowing for subcutaneous administration, which can be more convenient for patients as it reduces the need for frequent hospital visits. TAK-881 is noteworthy for its novel formulation that allows for a straightforward switch from HYQVIA, maintaining treatment efficacy with potentially improved patient comfort and adherence. These treatments not only aim to simplify the treatment process but also promise enhanced quality of life for individuals affected by CIDP.

What evidence suggests that this trial's treatments could be effective for CIDP?

This trial will compare the effectiveness of HYQVIA and TAK-881 for treating chronic inflammatory demyelinating polyneuropathy (CIDP). Research has shown that HYQVIA is effective for ongoing treatment in people with CIDP, with studies finding it has a low chance of the condition returning, thus helping to prevent relapses. It is also known to be safe and easy to manage over time. TAK-881, another treatment option in this trial, is being tested to determine if it works as well as HYQVIA when administered under the skin. The main goal is to find out if TAK-881 has similar effects in the body as HYQVIA. While TAK-881 is still under investigation, early results highlight its potential to be as effective as HYQVIA in its mechanism of action. ^{2 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. takeda.com takeda.com/newsroom/newsreleases/2024/takeda-presents-long-term-data-from-phase-3-advance-cidp-3-clinical-trial-of-hyqvia/

Takeda Presents Long-Term Data from ADVANCE-CIDP 3 ... Results showed favorable long-term safety and tolerability of HYQVIA, and a low relapse rate, supporting its use as maintenance treatment for CIDP.

2. hyqviahcp.com hyqviahcp.com/cidp/efficacy

ADVANCE-1 & 3 Study Data for HCPs - HyQvia HyQvia is indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11625974/

Long‐term safety and tolerability of hyaluronidase ... ADVANCE‐CIDP 3 demonstrated favorable fSCIG long‐term safety and tolerability consistent with its established safety profile, and a low relapse rate.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06538064

NCT06538064 | A Study of HyQvia in Adults With Chronic ... A Global Real-World Study to Assess HyQvia Use and Outcomes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Switching to ...

5. neurology.org neurology.org/doi/abs/10.1212/WNL.0000000000206312

Patient-reported Outcomes with Hyaluronidase-facilitated ... fSCIG is under investigation as a potential maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

6. hyqviahcp.com hyqviahcp.com/cidp/safety

HyQvia Safety in CIDP | ADVANCE-1 & 3 Study Data for ... Explore HyQvia safety information and review side effects. See Important Safety Info & Thrombosis Warning in Full Prescribing Info.

7. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/trial-data-safety-efficacy-hyqvia-chronic-inflammatory-demyelinating-polyneuropathy

Long-Term Phase III Trial Data Show Safety, Efficacy ... The FDA approved HyQvia as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with CIDP.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02955355

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia. All participants will receive HYQVIA/HyQvia in the same ...

9. hyqvia.com hyqvia.com/cidp

HyQvia SCIG Infusion for CIDP HyQvia [Ig Infusion (Human), 10% with Recombinant Human Hyaluronidase] Solution. See Important Safety Information & Blood Clot Warning for Patients.