Resumen

El objetivo principal de este estudio es evaluar la comparabilidad farmacocinética (FC) entre TAK-881 e HYQVIA administrados por vía subcutánea (SC) como terapia de mantenimiento para la PDIC. Los participantes que ya estén recibiendo inmunoglobulina G intravenosa (IGIV), inmunoglobulina G subcutánea convencional (IGSCc) o HYQVIA recibirán una dosis equivalente a su tratamiento previo con IG mediante HYQVIA durante 20 semanas, seguido de TAK-881 durante 24 semanas. Los participantes deberán acudir a la clínica cada 3 o 4 semanas hasta que entren en la fase de extensión. En la fase de extensión se permiten las infusiones domiciliarias, y las visitas se realizarán cada 12 a 24 semanas.

Descripción detallada

El estudio incluye una fase de cribado, una fase de titulación (si es necesaria), una fase de tratamiento con HYQVIA, una fase de tratamiento con TAK-881 y una fase de extensión. Los participantes que hayan recibido IGSCc o IGIV antes del estudio entrarán en una fase de titulación con HYQVIA, comenzando 1 a 2 semanas después de su última dosis de IGSCc o IGIV previa al estudio. Los participantes que ya estén recibiendo HYQVIA en el momento del cribado pasarán directamente a la fase de tratamiento. Tras la fase de dosificación con TAK-881, los participantes avanzarán a la fase de extensión con TAK-881, siendo preferible que las infusiones posteriores en la fase de extensión sean administradas por el propio participante o un cuidador en el domicilio.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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).
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.

Intervenciones

biological

TAK-881

Participants will receive SC infusion of TAK-881.

biological

HYQVIA

Participants will receive SC infusion of HYQVIA.

device

SC Investigational Needle Sets

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.

Ensayo clínico de fase 3, de un solo brazo, dosis múltiples, de comparabilidad farmacocinética entre TAK-881 e HYQVIA en adultos con polirradiculoneuropatía desmielinizante inflamatoria crónica

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

TAK-881

HYQVIA

SC Investigational Needle Sets

Ubicaciones

INECO

Instituto Argentino de Investigacion Neurologica (IADIN)

Patrocinadores

Contactos

Takeda Contact