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Compares treatment options for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Official title A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
ClinicalTrials.gov ID: NCT06747351
What this study is testing
What is TAK-881?
TAK-881 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic inflammatory demyelinating polyradiculoneuropathy (cidp).
Also referred to as Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)..
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Participant has a documented diagnosis of CIDP or possible CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and...
- 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...
You likely can't join if
- Participant with documented diagnosis of focal, multifocal, distal, or sensory CIDP, or possible focal, multifocal, distal, or sensory CIDP per the...
- 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...
- Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic...
- Multifocal motor neuropathy (MMN).
- Drug, biologic, chemotherapy, or toxin-induced peripheral neuropathy.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Palo Alto, California, United States
- New Haven, Connecticut, United States
- Maitland, Florida, United States
- Rockledge, Florida, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Raleigh, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Denton, Texas, United States
- Burlington, Vermont, United States
- Greenfield, Wisconsin, United States
- Rosario, Santa Fe Province, Argentina
- Buenos Aires, Argentina
- Hradec Králové, Czechia
- Copenhagen, Capital Region, Denmark
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Palo Alto, California, United States; New Haven, Connecticut, United States; Maitland, Florida, United States; Rockledge, Florida, United States; St Louis, Missouri, United States and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.