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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Takeda Development Center Americas Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

23 Jun 2025 → ongoing

Decision date (initial)

2025-06-03

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Takeda Development Center Americas, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

01. To demonstrate PK comparability of TAK-881 and HYQVIA at steady-state following SC administration in participants with CIDP.

Conditions and MedDRA coding

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 01. The participant is willing and able to understand and fully comply with trial procedures and requirements, in the opinion of the investigator.
2. 02. The participant has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any trial procedures.
3. 03. The participant is at least 18 years of age at the time of signing the ICF.
4. 04. The participant has a documented diagnosis of CIDP or possible CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and consistent with the EAN/PNS 2021 criteria (Van den Bergh et al., 2021).
5. 05. The participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).
6. 06. The participant is on a stable, pretrial treatment with IGIV, cIGSC, or HYQVIA (also known as TAK-771 in Japan) within the dose range equivalent to a cumulative monthly IgG dose of 0.4 to 2.4 g/kg body weight (BW) (inclusive) administered for at least 12 weeks before screening. The dosing interval of IGIV treatment must be between 2 and 6 weeks (inclusive). The dosing interval must be weekly or biweekly for cIGSC dosing and ≤6 weeks for HYQVIA dosing. Prior to screening, variations in the dosing interval of up to ±7 days or monthly dose amount of up to ±20% between the participant’s consecutive pretrial IgG infusions are acceptable.
7. 07. The participant has an INCAT disability score between 0 and 7 (inclusive). Participants will be eligible if one of the below eligibility criteria are met: a. Screening INCAT disability score of between 3 and 7 inclusive. b. Screening INCAT disability score of 2 (both points are from lower extremities). c. Screening INCAT disability score of 2 (both points are not from lower extremities) AND has at least a score of 2 or greater documented in the medical record before screening. If a score was greater than 2 documented in the medical record before screening at least 2 points must be from lower extremities. d. Screening INCAT disability score of 0 or 1 AND has at least a score of 2 or greater (both from lower extremities) documented in the medical record before screening, at least 2 points must be from lower extremities.
8. 08. If a participant has the potential to become pregnant, they must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the trial and for at least 30 days after the last administration of IMP.

Exclusion criteria 24

1. 01. Documented diagnosis of focal, multifocal, distal, or sensory CIDP, or possible focal, multifocal, distal, or sensory CIDP per the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2021 criteria (Van den Bergh et al., 2021).
2. 02. The participant has any neuropathy of other causes, including: a. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN), Charcot-Marie-Tooth (CMT) disease, and hereditary sensory and autonomic neuropathies (HSANs). b. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, amyloidosis. c. Multifocal motor neuropathy (MMN). d. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy.
3. 03. The participant has any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or which may interfere with assessment of CIDP or outcome measures, including (but not limited to) multiple sclerosis, arthritis, stroke, Parkinson’s disease, and diabetic peripheral neuropathy. Note: Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy and who have adequate glycemic control with hemoglobin A1c [HbA1c] level of <7.5% at screening will be eligible for the trial, provided the electrodiagnostic criteria are consistent with the diagnosis of CIDP or possible CIDP consistent with the EFNS/PNS 2021 criteria and the participant agrees to maintain adequate glycemic control.
4. 04. The participant is required to take or has taken immunomodulatory/immunosuppressive agents (except IGIV, cIGSC, or fIGSC) that include but are not limited to specific complement inhibitors, rituximab, neonatal Fc receptor inhibitors (eg, efgartigimod), and chemotherapeutic drugs, within 6 months of screening. Participants on a long-term, stable dosing regimen of certain immunomodulatory agents (eg, hydroxychloroquine) for the treatment of non-CIDP conditions may be included in the trial.
5. 05. The participant is required to take or has taken long-term systemic corticosteroids defined as dosages >20 mg/day prednisone-equivalent for >30 days within 3 months of screening. Note: Participants using short-pulse dose corticosteroid course and oral daily corticosteroids ≤20 mg/day prednisone-equivalent are allowed.
6. 06. The participant has undergone plasma exchange within 3 months before screening.
7. 07. The participant has immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with a high titer of antibody to myelin-associated glycoprotein.
8. 08. The participant has immunoglobulin A (IgA) deficiency (IgA <0.07 g/L) associated with known anti-IgA antibodies and a history of hypersensitivity to human immunoglobulin treatment.
9. 09. The participant has a condition(s) which could alter protein catabolism and/or IgG use (eg, protein losing enteropathies, and nephrotic syndrome).
10. 10. The participant has a history or clinical manifestations of chronic kidney disease, or glomerular filtration rate of <30 mL/min/1.73 m2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al., 2009) at the time of screening.
11. 11. The participant has a history of malignancy with less than 2 years of complete remission before screening, or active malignancy requiring chemotherapy and/or radiotherapy. Note: Participants with adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stable prostate cancer not requiring treatment are eligible.
12. 12. The participant has congestive heart failure (New York Heart Association class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (defined as diastolic blood pressure >100 mm Hg and/or systolic blood pressure >160 mm Hg during the screening epoch confirmed on 2 measures >30 minutes apart).
13. 13. The participant has an acquired or inherited thrombophilic disorder, such as protein C deficiency, protein S deficiency, antithrombin deficiency, and primary antiphospholipid antibody syndrome.
14. 14. The participant has a history of deep vein thrombosis or arterial thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) within 12 months before screening.
15. 15. The participant has any medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the participant at undue medical risk.
16. 16. Participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC IGSC immunoglobulin, and/or immune serum globulin infusions.
17. 17. The participant has a known systemic hypersensitivity to any of the excipients of TAK-881/HYQVIA in accordance with the IB/package insert/Summary of Product Characteristics (SmPC).
18. 18. Participant has a known systemic hypersensitivity to hyaluronidase or rHuPH20.
19. 19. The participant has a known history of positive result for or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for HIV Type 1 and Type 2. Note: Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible.
20. 20. The participant has clinically significant anemia that precludes repeated blood sampling during the trial, or hemoglobin level of <10.0 g/dL at the time of screening. Note: If in investigator judgement, the screening laboratory abnormalities are likely to be transient, then laboratory tests may be repeated. The investigator rationale is to be documented. Laboratory values can be retested once during screening as long as the participant can be evaluated for eligibility and can be enrolled within the allowed screening epoch.
21. 21. The participant has any of the following laboratory values at screening: a. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN). b. Platelet count <100,000 cells/μL. c. Absolute neutrophil count <1000 cells/μL. Note: If in investigator judgement, the screening laboratory abnormalities are likely to be transient, then laboratory tests may be repeated. The investigator rationale is to be documented. Laboratory values can be retested once during screening as long as the participant can be evaluated for eligibility and can be enrolled within the allowed screening epoch.
22. 22. If female, the participant is pregnant or lactating at the time of screening
23. 23. The participant has participated in another clinical trial involving an IMP or investigational device within 12 weeks or 5◦half-lives, whichever is longer, before enrollment (except for participants rolling over from the Japan study TAK-771-3002) or is scheduled to participate in another clinical trial involving an IMP or investigational device during the course of this trial.
24. 24. The participant is a trial site employee, an immediate family member (eg, spouse, parent, child, sibling), or is in a dependent relationship with a trial site employee who is involved in conduct of this trial, or may consent under duress.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 01. Baseline-uncorrected area under the curve during the dosing interval at steady-state (AUC0-τ,ss) based on total IgG levels.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Takeda Development Center Americas Inc.

Sponsor organisation

Takeda Development Center Americas Inc.

Address

500 Kendall Street

City

Cambridge

Postcode

02142-1108

Country

United States

Scientific contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Chris Yuskaitis

Public contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Takeda

Third parties 13

Locations

8 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 108 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications