A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Interventions
- Registration Number
- NCT06747351
- Lead Sponsor
- Takeda
- 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 24 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Participants (HYQVIA and TAK-881) TAK-881 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. All Participants (HYQVIA and TAK-881) HYQVIA 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. All Participants (HYQVIA and TAK-881) SC Investigational Needle Sets 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Number of Participants With Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) who Experienced Relapse Related to Baseline Baseline up to 24 weeks 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.
Change From Baseline in Hand Grip Strength Baseline up to 24 weeks 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).
Change From Baseline in Medical Research Council (MRC) Sum Score Baseline up to 24 weeks 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.
Change From Baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Centile Score Baseline up to 24 weeks 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to 4.06 years Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs 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 Up to 4.06 years Number of Infusions per Month at Full Dose With Both TAK-881 and HYQVIA in all Participants 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 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 Up to Week 55 Duration of Infusions (Minutes) at Full Dose With Both TAK-881 and HYQVIA in all Participants Up to 4.06 years Monthly Infusion Time (Minutes/Month) at Full Dose With Both TAK-881 and HYQVIA in all Participants 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 Up to Week 55 Infusion Volume per Site (mL/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants Up to Week 55 Time of Infusion Preparation Measured by Healthcare provider (HCP) Up to 4.06 years