Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Phase 3NCT06747351
A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A Phase 3 study testing TAK-881, HYQVIA and SC Investigational Needle Sets in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), run by Takeda at 52 sites in 11 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- What is being tested?
- TAK-881, HYQVIA and SC Investigational Needle Sets
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 52 sitesin 11 countries
- Study dates
- 6 May 2025to 25 Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
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- 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).
- Participant has a history or clinical manifestations of chronic kidney disease, or glomerular filtration rate of <30 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening.
- 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.
- 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 millimeters of mercury (mm Hg) and/or systolic blood pressure >160 mm Hg during the screening epoch confirmed on 2 measures >30 minutes apart).
- Participant has an acquired or inherited thrombophilic disorder, such as protein C deficiency, protein S deficiency, antithrombin deficiency, and primary antiphospholipid antibody syndrome.
- Participant has a history of deep vein thrombosis or arterial thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) within 12 months before screening.
- 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.
- Participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, IGSC, and/or immune serum globulin infusions.
- Participant has a known systemic hypersensitivity to any of the excipients of TAK-881/HYQVIA in accordance with the Investigator's Brochure (IB)/package insert/Summary of Product Characteristics (SmPC).
- Participant has a known systemic hypersensitivity to hyaluronidase or rHuPH20.
- 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 Human Immunodeficiency Virus (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.
- Participant has clinically significant anemia that precludes repeated blood sampling during the trial, or hemoglobin level of <10.0 grams per deciliter (g/dL) at the time of screening.
- Participant has any of the following laboratory values at screening:
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5*upper limit of normal (ULN).
- Platelet count <100,000 cells per microliter (cells/µL).
- Absolute neutrophil count <1000 cells/µL.
- If female, the participant is pregnant or lactating at the time of screening.
- 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.
- 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.
Trial locations and contacts
52 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
52 sites in 11 countries
United States16 sites, 16 recruiting
- Not yet recruiting
The University of Vermont Medical Center
Burlington, Vermont, 05401
Site Contact, waqar.waheed@uvmhealth.org
Waqar Waheed
- Recruiting
University of North Carolina (UNC)
Chapel Hill, North Carolina, 27599
Site Contact, rtraub@neurology.unc.edu
Rebecca Traub
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Site Contact, andrapn2@ccf.org
Nirmal Andrapalliyal
- Recruiting
Neurology Rare Disease Center
Denton, Texas, 76208
Site Contact, DrCastro@Neuromdcenter.com
Diana Castro
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Site Contact, karissa.gable@duke.edu
Karissa Gable
- Recruiting
BCN Research, LLC
Greenfield, Wisconsin, 53228
Site Contact, milwaukee4145@gmail.com
Bhupendra Khatri
- Recruiting
Neurology Associates
Maitland, Florida, 32751
Site Contact, aisa.naparesearch@gmail.com
Arnaldo Isa
- Not yet recruiting
Yale University School of Medicine
New Haven, Connecticut, 06510
Site Contact, bhaskar.roy@yale.edu
Bhaskar Roy
- Recruiting
NYU Langone Health
New York, New York, 10016
Site Contact, mark.gudesblatt@nyulangone.org
Mark Gudesblatt
- Not yet recruiting
Stanford Neuroscience Health Center
Palo Alto, California, 94304
Site Contact, muppidis@stanford.edu
Srikanth Muppidi
- Not yet recruiting
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill
Portland, Oregon, 97239
Site Contact, chahin@ohsu.edu
Nizar Chahin
- Recruiting
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Site Contact, tryan@raleighneurology.com
Timothy Ryan
- Recruiting
Knight Neurology
Rockledge, Florida, 32955
Site Contact, vshah@knightneurology.com
Vaibhav Shah
- Recruiting
HonorHealth Neurology
Scottsdale, Arizona, 85251
Site Contact, suraj.muley@dignityhealth.org
Suraj Muley
- Not yet recruiting
The Washington University
St Louis, Missouri, 63130
Site Contact, c.roach@wustl.edu
Charles Roach
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Site Contact, rgandhi@wakehealth.edu
Rachana Gandhi
Italy9 sites, 9 recruiting
- Not yet recruiting
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, 25123
Site Contact, alessandro.padovani@unibs.it
Alessandro Padovani
- Not yet recruiting
Ospedale San Martino
Genova, 16132
Site Contact, luanabenedetti@libero.it
Luana Benedetti
- Not yet recruiting
Az Ospedaliera Universitaria Policlinico G Martino
Messina, 98125
Site Contact, luca.gentile@unime.it
Luca Gentile
- Not yet recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Lombardy, 20132
Site Contact, previtali.stefano@hsr.it
Stefano Previtali
- Not yet recruiting
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino, Piemonte, 10043
Site Contact, mariana.canaro@ssib.es
Marinella Clerico
- Not yet recruiting
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
Site Contact, enrico.marchioni@mondino.it
Enrico Marchioni
- Not yet recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Site Contact, g.siciliano@med.unipi.it
Gabriele Siciliano
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, 00133
Site Contact, marfia@uniroma2.it
Girolama Alessandra Marfia
- Not yet recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Lombardia, 20089
Site Contact, giuseppe.liberatore@humanitas.it
Giuseppe Liberatore
Japan8 sites, 8 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Site Contact, zawa@juntendo.ac.jp
Yuji Tomizawa
- Recruiting
Higashimatsuyama Municipal Hospital
Higashi-Matsuyama, Saitama, 355-0005
Site Contact, drno.chiken@gmail.com
Kyoichi Nomura
- Not yet recruiting
Nara Medical University Hospital
Kashihara, Nara, 634-8522
Site Contact, ksugie@naramed-u.ac.jp
Kazuma Sugie
- Recruiting
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
Site Contact, caramelbox0106@gmail.com
Toshiya Nomura
- Not yet recruiting
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
Nagoya, Aichi-ken, 455-8530
Site Contact, ch-kamijo@mail.goo.ne.jp
Mikiko Kamijo
- Not yet recruiting
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192
Site Contact, uru@belle.shiga-med.ac.jp
Makoto Urushitani
- Not yet recruiting
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi, 981-8558
Site Contact, nakashima@med.tohoku.ac.jp
Ichiro Nakashima
- Not yet recruiting
Tokushima University Hospital
Tokushima, Tokuchima, 770-8503
Site Contact, yosaki@tokushima-u.ac.jp
Yusuke Osaki
Germany5 sites, 5 recruiting
- Not yet recruiting
Charite - Universitatsmedizin Berlin
Berlin, 12203
Site Contact, fabian.klostermann@charite.de
Fabian Klostermann
- Not yet recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Site Contact, Skripuletz.Thomas@MH-Hannover.de
Thomas Skripuletz
- Not yet recruiting
Universitätsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
Site Contact, hans-werner.rausch@umm.de
Hans-Werner Rausch
- Not yet recruiting
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Marburg, Hesse, 35043
Site Contact, Clemens.warnke@uni-marburg.de
Clemens Warnke
- Not yet recruiting
University of Ulm
Ulm, Baden-Wurttemberg, 89081
Site Contact, angela.rosenbohm@uni-ulm.de
Angela Rosenbohm
Poland4 sites, 4 recruiting
- Not yet recruiting
Copernicus Podmiot Leczniczy
Gdansk, Pomeranian Voivodeship, 80-462
Site Contact, jaroslawek@gumed.edu.pl
Jaroslaw Slawek
- Not yet recruiting
Oddzial Kliniczny Neurologii
Krakow, Lesser Poland Voivodeship, 30-688
Site Contact, neurologia@su.krakow.pl
Agnieszka Slowik
- Recruiting
Clinirem Sp zo.o.
Lublin, Lublin Voivodeship, 20-064
Site Contact
Urszula Chyrchel-Paszkiewicz
- Not yet recruiting
Warszawski Uniwersytet Medyczny
Warsaw, Masovian Voivodeship, 02-097
Site Contact, anna.kostera-pruszczyk@wum.edu.pl
Anna Kostera-Pruszczyk
Argentina2 sites, 2 recruiting
- Not yet recruiting
Instituto Argentino de Investigacion Neurologica (IADIN)
Buenos Aires, C1015ABR
Site Contact, robertorey@iadin.com.ar
Roberto Rey
- Not yet recruiting
INECO
Rosario, Santa Fe Province, 2000
Site Contact, dtavolini@inecoorono.org
Dario Tavolini
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus Universitetshospital
Aarhus, Central Jutland, 8200
Site Contact, Larsmark@rm.dk
Lars Markvardsen
- Not yet recruiting
Copenhagen University Hospital
Copenhagen, Capital Region, 2100d
Site Contact, tina.dysgaard@regionh.dk
Tina Dysgaard
Greece2 sites, 2 recruiting
- Not yet recruiting
Attikon University General Hospital
Athens, Attica, 12462
Site Contact, tsivgoulisgiorg@yahoo.gr
Georgios Tsivgoulis
- Not yet recruiting
University General Hospital of Patras
Patras, Peloponnese, 26504
Site Contact, echroni@yahoo.com
Elisabeth Chroni
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital de La Santa Creu I San Pau
Barcelona, 08041
Site Contact, lquerol@santpau.cat
Luis Antonio Querol Gutierrez
- Not yet recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Site Contact, sevilla_ter@gva.es
Teresa Sevilla Mantecon
Czechia1 site, 1 recruiting
- Not yet recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Site Contact, pavel.kunc@fnhk.cz
Pavel Kunc
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, 41345
Site Contact, lenka.novakova@vgregion.se
Lenka Novakova Nyren
About this study
Official title: A Phase 3, Single-Arm, Multiple-Dose, Pharmacokinetic Comparability Trial Between TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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.
Read the 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.
- Being tested
- TAK-881, HYQVIA, SC Investigational Needle Sets
- Keywords
- Immunoglobulin, facilitated subcutaneous , Immunoglobulin;, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-881Biological
Also called Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20).
Participants will receive SC infusion of TAK-881.
HYQVIABiological
Also called Immune Globulin Infusion (Human), 10% Solution with rHuPH20
Participants will receive SC infusion of HYQVIA.
SC Investigational Needle SetsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: TAK-881; Biological: HYQVIA; Device: SC Investigational Needle Sets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-Uncorrected Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) Based on Total Immunoglobulin G (IgG) Levels
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 4.06 years
Number of Participants With Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) who Experienced Relapse Related to Baseline
Relapse is defined as an increase in the adjusted INCAT disability score by greater than and equal to (>=) 1-point relative to the baseline score. The INCAT disability score is a clinician-reported measure of a participant's level of arm and leg impairment. The arm and leg components of the INCAT are scored between 0 and 5 points (where arm = 0 indicates 'no upper limb problems' and arm = 5 indicates 'inability to use either arm for any purposeful movement', and leg = 0 indicates 'walking not affected', and leg = 5 indicates 'restricted to wheelchair, unable to stand and walk a few steps with help') and are summed to produce the overall INCAT disability score ranging between 0 and 10 points. A score of 0 indicates no signs of disability) and 10 indicates the most severe disability.
Measured: Baseline up to 24 weeks
Change From Baseline in Hand Grip Strength
Grip strength assessments conducted by prescribing physicians using the Martin Vigorimeter or the Jamar Dynamometer (as available at the site and performed per routine clinical practice).
Measured: Baseline up to 24 weeks
Change From Baseline in Medical Research Council (MRC) Sum Score
The MRC sum score measures muscle strength from both the left and right sides of the body on a scale of 0 to 5. The total MRC sum score ranges from 0 (paralysis) to 60 (normal strength), where higher score indicates better strength.
Measured: Baseline up to 24 weeks
Change From Baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Centile Score
The I-RODS is a validated, participants self-reported, linearly weighted overall disability scale that was specifically designed to capture current activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. The I-RODS comprises 24 items for which participants are asked to rate their functioning related to a variety of everyday tasks at the moment of completion. The participant assigns a score between 0 and 2 to each item as follows: 0 (impossible to perform), 1 (performed with difficulty), 2 (easily performed) with a lower score indicating more severe activity and social participation limitations.
Measured: Baseline up to 24 weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 4.06 years
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs
Measured: Up to Week 55
Number of Participants With Positive Binding Antibodies (Titer Greater than and equal to [>=] 1:160) and With Positive Neutralizing Antibodies to rHuPH20
Measured: Up to 4.06 years
Number of Infusions per Month at Full Dose With Both TAK-881 and HYQVIA in all Participants
Measured: Up to 4.06 years
Number of Infusions Sites (Needle Sticks) per Month at Full Dose With Both TAK-881 and HYQVIA in all Participant
Measured: Up to 4.06 years
Number of Infusions Sites (Needle Sticks) per Infusion at Full Dose With Both TAK-881 and HYQVIA in all Participants
Measured: Up to Week 55
Duration of Infusions (Minutes) at Full Dose With Both TAK-881 and HYQVIA in all Participants
Measured: Up to 4.06 years
Monthly Infusion Time (Minutes/Month) at Full Dose With Both TAK-881 and HYQVIA in all Participants
Measured: Up to 4.06 years
Maximum Tolerated Infusion Rate per Site (milliliter [mL]/hour/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants
Measured: Up to Week 55
Infusion Volume per Site (mL/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants
Measured: Up to Week 55
Time of Infusion Preparation Measured by Healthcare provider (HCP)
Measured: Up to 4.06 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start6 May 2025
- Primary completion25 Jun 2028 (estimated)
- Study completion25 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747351
- Sponsor's protocol ID
- TAK-881-3003
- Other IDs
- 2024-517450-95-00, jRCT2041250014
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.