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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Participants will receive SC infusion of TAK-881.
Participants will receive SC infusion of HYQVIA.
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.
HonorHealth Neurology
Scottsdale, Arizona, United States
RECRUITINGStanford Neuroscience Health Center
Palo Alto, California, United States
NOT_YET_RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
NOT_YET_RECRUITINGNeurology Associates
Maitland, Florida, United States
Baseline-Uncorrected Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) Based on Total Immunoglobulin G (IgG) Levels
Time frame: 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 Area Under the Curve to the Last Measurable Concentration at Steady-State (AUClast,ss) Based on Total IgG Levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 24 weeks
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 4.06 years
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs
Time frame: 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
Time frame: Up to 4.06 years
Number of Infusions per Month at Full Dose With Both TAK-881 and HYQVIA in all Participants
Time frame: 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
Time frame: 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
Time frame: Up to Week 55
Duration of Infusions (Minutes) at Full Dose With Both TAK-881 and HYQVIA in all Participants
Time frame: Up to 4.06 years
Monthly Infusion Time (Minutes/Month) at Full Dose With Both TAK-881 and HYQVIA in all Participants
Time frame: 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
Time frame: Up to Week 55
Infusion Volume per Site (mL/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants
Time frame: Up to Week 55
Time of Infusion Preparation Measured by Healthcare provider (HCP)
Time frame: Up to 4.06 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Knight Neurology
Rockledge, Florida, United States
RECRUITINGThe Washington University
St Louis, Missouri, United States
NOT_YET_RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGUniversity of North Carolina (UNC)
Chapel Hill, North Carolina, United States
RECRUITINGDuke University Hospital
Durham, North Carolina, United States
RECRUITINGRaleigh Neurology Associates
Raleigh, North Carolina, United States
RECRUITING...and 42 more locations