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

NCT06747351 | Recruiting Phase 3 FDA Drug FDA Device

• 3 other identifiers: TAK-881-30032024-517450-95-00jRCT2041250014
• Study Type: interventional
• Target: 59
• Locations: 11 countries
• Sites: 52

Brief 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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Keywords

Immunoglobulin; facilitated subcutaneous , Immunoglobulin;; Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Outcome Measures

Primary Outcomes (1)

• Baseline-Uncorrected Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) Based on Total Immunoglobulin G (IgG) Levels

  3-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 17, 21 days (post-infusion); 4-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 21, 28 days (post-infusion) of last infusion

Secondary Outcomes (20)

• Baseline-Uncorrected Area Under the Curve to the Last Measurable Concentration at Steady-State (AUClast,ss) Based on Total IgG Levels

  3-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 17, 21 days (post-infusion); 4-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 21, 28 days (post-infusion) of last infusion

• Baseline-Uncorrected Time of the Last Measurable Concentration at Steady-State (Tlast,ss) Based on Total IgG Levels

  3-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 17, 21 days (post-infusion); 4-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 21, 28 days (post-infusion) of last infusion

• Baseline-Uncorrected Maximum Observed Concentration at Steady-State (Cmax,ss) Based on Total IgG Levels

  3-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 17, 21 days (post-infusion); 4-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 21, 28 days (post-infusion) of last infusion

• Baseline-Uncorrected Time to Maximum Concentration at Steady-State (Tmax,ss) Based on Total IgG Levels

  3-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 17, 21 days (post-infusion); 4-Week dosing: Day 1 (pre- and post-infusion), 24, 72, 120 hours and 7, 14, 21, 28 days (post-infusion) of last infusion

• Total IgG Trough Level

  Up to 4.06 years

Study Arms (1)

All Participants (HYQVIA and TAK-881)

EXPERIMENTAL

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.

Biological: TAK-881; Biological: HYQVIA; Device: SC Investigational Needle Sets

Interventions

TAK-881 BIOLOGICAL

Participants will receive SC infusion of TAK-881.

Also known as: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20).

All Participants (HYQVIA and TAK-881)

HYQVIA BIOLOGICAL

Participants will receive SC infusion of HYQVIA.

Also known as: Immune Globulin Infusion (Human), 10% Solution with rHuPH20

All Participants (HYQVIA and TAK-881)

SC Investigational Needle Sets DEVICE

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.

All Participants (HYQVIA and TAK-881)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to understand and fully comply with trial procedures and requirements, in the opinion of the investigator.
• Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent Form \[ICF\]) and any required privacy authorization before the initiation of any trial procedures.
• Participant has a documented diagnosis of CIDP or possible CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and consistent with the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2021 criteria.
• Participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).
• 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 grams per kilogram (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 less than or equal (\<=) to 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 percentage (%) between the participant's pretrial IgG infusions are acceptable.
• Participant has an INCAT disability score between 0 and 7 (inclusive). Participants will be eligible if one of the below eligibility criteria are met:
• Screening INCAT disability score of between 3 and 7 inclusive.
• Screening INCAT disability score of 2 (both points are from lower extremities).
• 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.
• 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.
• 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 the investigational medical product (IMP).

You may not qualify if:

• Participant with documented diagnosis of focal, multifocal, distal, or sensory CIDP, or possible focal, multifocal, distal, or sensory CIDP per the EFNS/PNS 2021 criteria.
• Participant has any neuropathy of other causes, including:
• Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN), Charcot-Marie-Tooth (CMT) disease, and hereditary sensory and autonomic neuropathies (HSANs).
• 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.
• Multifocal motor neuropathy (MMN).
• Drug, biologic, chemotherapy, or toxin-induced peripheral neuropathy.
• 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 less than (\<) 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.
• 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 (e.g. efgartigimod), and chemotherapeutic drugs, within 6 months of screening.
• Participant is required to take or has taken long-term systemic corticosteroids defined as dosages greater than (\>) 20 milligrams per day (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.
• Participant has undergone plasma exchange within 3 months before screening.
• Participant has immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with a high titer of antibody to myelin-associated glycoprotein.
• Participant has immunoglobulin A (IgA) deficiency (IgA \<0.07 grams per liter \[g/L\]) associated with known anti-IgA antibodies and a history of hypersensitivity to human immunoglobulin treatment.
• Participant has a condition(s) which could alter protein catabolism and/or IgG use (for example \[eg.\] protein losing enteropathies, and nephrotic syndrome).

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (52)

HonorHealth Neurology

Scottsdale, Arizona, 85251, United States

RECRUITING

Stanford Neuroscience Health Center

Palo Alto, California, 94304, United States

NOT YET RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Neurology Associates

Maitland, Florida, 32751, United States

RECRUITING

Knight Neurology

Rockledge, Florida, 32955, United States

RECRUITING

The Washington University

St Louis, Missouri, 63130, United States

NOT YET RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

University of North Carolina (UNC)

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Neurology Rare Disease Center

Denton, Texas, 76208, United States

RECRUITING

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

NOT YET RECRUITING

BCN Research, LLC

Greenfield, Wisconsin, 53228, United States

RECRUITING

INECO

Rosario, Santa Fe Province, 2000, Argentina

NOT YET RECRUITING

Instituto Argentino de Investigacion Neurologica (IADIN)

Buenos Aires, C1015ABR, Argentina

NOT YET RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

NOT YET RECRUITING

Copenhagen University Hospital

Copenhagen, Capital Region, 2100d, Denmark

NOT YET RECRUITING

Aarhus Universitetshospital

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Universitätsklinikum Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

NOT YET RECRUITING

University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

NOT YET RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg

Marburg, Hesse, 35043, Germany

NOT YET RECRUITING

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

NOT YET RECRUITING

Charite - Universitatsmedizin Berlin

Berlin, 12203, Germany

NOT YET RECRUITING

Attikon University General Hospital

Athens, Attica, 12462, Greece

NOT YET RECRUITING

University General Hospital of Patras

Patras, Peloponnese, 26504, Greece

NOT YET RECRUITING

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

NOT YET RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, Lombardia, 20089, Italy

NOT YET RECRUITING

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Torino, Piemonte, 10043, Italy

NOT YET RECRUITING

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

Brescia, 25123, Italy

NOT YET RECRUITING

Ospedale San Martino

Genova, 16132, Italy

NOT YET RECRUITING

Az Ospedaliera Universitaria Policlinico G Martino

Messina, 98125, Italy

NOT YET RECRUITING

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, 27100, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, 00133, Italy

NOT YET RECRUITING

Japan Organization of Occupational Health and Safety Chubu Rosai Hospital

Nagoya, Aichi-ken, 455-8530, Japan

NOT YET RECRUITING

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

RECRUITING

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, 981-8558, Japan

NOT YET RECRUITING

Nara Medical University Hospital

Kashihara, Nara, 634-8522, Japan

NOT YET RECRUITING

Higashimatsuyama Municipal Hospital

Higashi-Matsuyama, Saitama, 355-0005, Japan

RECRUITING

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

NOT YET RECRUITING

Tokushima University Hospital

Tokushima, Tokuchima, 770-8503, Japan

NOT YET RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Oddzial Kliniczny Neurologii

Krakow, Lesser Poland Voivodeship, 30-688, Poland

NOT YET RECRUITING

Clinirem Sp zo.o.

Lublin, Lublin Voivodeship, 20-064, Poland

RECRUITING

Warszawski Uniwersytet Medyczny

Warsaw, Masovian Voivodeship, 02-097, Poland

NOT YET RECRUITING

Copernicus Podmiot Leczniczy

Gdansk, Pomeranian Voivodeship, 80-462, Poland

NOT YET RECRUITING

Hospital de La Santa Creu I San Pau

Barcelona, 08041, Spain

NOT YET RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

NOT YET RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götaland County, 41345, Sweden

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

gamma-Globulins; Solutions

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pharmaceutical Preparations

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 24, 2024
• Study Start: May 6, 2025
• Primary Completion (Estimated): June 25, 2028
• Study Completion (Estimated): June 25, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

GR (2); IT (9); AR (2); PL (4); ES (2); CZ (1); US (16); DK (2); JP (8); SE (1); DE (5)