Trial Outcomes & Findings for A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) (NCT NCT05084053)

NCT ID: NCT05084053

Last Updated: 2025-11-26

Results Overview

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

26 participants

Primary outcome timeframe

Epoch 1: Baseline up to 6 months

Results posted on

2025-11-26

Participant Flow

Participants took part in the study at 23 investigative sites in Japan. A total of 26 participants were enrolled and treated in this study, which consisted of two treatment epochs (Epoch 1 and Epoch 2) with two cohorts: chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in Cohort 1 and multifocal motor neuropathy (MMN) in Cohort 2.

The results are presented up to Epoch 2 (6 months), based on the second interim analysis cutoff date (August 20, 2024). The study is ongoing, and participants who have tolerated the treatment well and voluntarily wish to continue TAK-771 administration may remain in Epoch 2 (continued) until the commercial availability of TAK-771. Additional results will be provided upon study completion date.

Participant milestones

Participant milestones
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Up to 6 months STARTED	19	7	0	0
Epoch 1: Up to 6 months Treated	19	7	0	0
Epoch 1: Up to 6 months COMPLETED	17	7	0	0
Epoch 1: Up to 6 months NOT COMPLETED	2	0	0	0
Epoch 2: Up to 6 months STARTED	0	0	16	7
Epoch 2: Up to 6 months Treated	0	0	16	7
Epoch 2: Up to 6 months COMPLETED	0	0	15	7
Epoch 2: Up to 6 months NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Up to 6 months Withdrawal by Subject	1	0
Epoch 1: Up to 6 months Physician Decision	1	0
Epoch 2: Up to 6 months Physician Decision	0	1

Baseline Characteristics

A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Total n=26 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 17.27 • n=492 Participants	57.4 years STANDARD_DEVIATION 15.71 • n=492 Participants	55.6 years STANDARD_DEVIATION 16.59 • n=984 Participants
Sex: Female, Male Female	8 Participants n=492 Participants	2 Participants n=492 Participants	10 Participants n=984 Participants
Sex: Female, Male Male	11 Participants n=492 Participants	5 Participants n=492 Participants	16 Participants n=984 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=492 Participants	7 Participants n=492 Participants	26 Participants n=984 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) Asian	19 Participants n=492 Participants	7 Participants n=492 Participants	26 Participants n=984 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) Black or African American	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) White	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) More than one race	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=492 Participants	0 Participants n=492 Participants	0 Participants n=984 Participants

PRIMARY outcome

Timeframe: Epoch 1: Baseline up to 6 months

Population: FAS included all enrolled participants who received TAK-771 at least once.

Relapse was defined as worsening of functional disability defined as an increase of \>=1 point relative to the pre-subcutaneous (pre-SC) treatment baseline score in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability scale was the most widely used assessment tool to measure the functional activity level of participants with CIDP. The INCAT disability scale consisted of upper and lower extremity components, with a maximum of 5 points for the upper extremities (arm disability) and a maximum of 5 points for the lower extremities (leg disability), which were summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 was normal and 10 was severely incapacitated. An adjusted INCAT disability score was the same as the INCAT disability score, with the only exception in the exclusion of changes from 0 (normal) to 1 (minor symptoms) (or vice versa) in upper limb function.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Percentage of Participants With CIDP Who Experienced Relapse	0 percentage of participants Interval 0.0 to 17.65	—	—	—

PRIMARY outcome

Timeframe: Epoch 1: Baseline up to 6 months

Population: FAS included all enrolled participants who received TAK-771 at least once.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=7 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Change From Baseline in Maximum Grip Strength in the More Affected Hand in Participants With MMN	-1.1 kPa Standard Deviation 12.73	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: Safety analysis set (SAS)included all enrolled participants who received TAK-771 administration at least once.

TEAEs were defined as adverse events that occurred during or after administration of the first dose of investigational product (IP). TEAEs caused in Epoch 1 were defined as AEs that occurred on or after the start of study drug administration, and before the first dose of IP in Epoch 2 (6 months). TEAEs caused in Epoch 2 (6 months) were defined as AEs that began during or after administration of the first dose of IP in Epoch 2 (6 months).

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs)	16 Participants	7 Participants	11 Participants	6 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

SAEs were defined as any untoward clinical manifestation of signs, symptoms, outcomes (related to IP or not) at any dose: resulted in death, was life-threatening, required inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, or any other important medical event.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

Related SAES and TEAEs: that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which possible involvement of the drug cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant medications and concurrent treatments, may also be responsible.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs Participants With Related SAEs	0 Participants	0 Participants	0 Participants	0 Participants
Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs Participants With Related TEAEs	11 Participants	5 Participants	7 Participants	4 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious Adverse Reactions (ARs) Plus Suspected ARs Participants with non-serious ARs Plus Suspected ARs	12 Participants	6 Participants	7 Participants	4 Participants
Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious Adverse Reactions (ARs) Plus Suspected ARs Participants with Serious ARs Plus Suspected ARs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

Infusion associated SAEs and/or TEAEs were defined as SAEs and/or TEAEs considered to be "infusion-related reactions" by investigators.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With SAEs and/or TEAEs Associated With Infusions Participants with SAEs associated with Infusions	0 Participants	0 Participants	0 Participants	0 Participants
Epoch 1 and 2 (6 Months): Number of Participants With SAEs and/or TEAEs Associated With Infusions Participants with TEAEs associated with Infusions	9 Participants	5 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs Associated With Infusions Participants With Related SAEs Associated With Infusions	0 Participants	0 Participants	0 Participants	0 Participants
Epoch 1 and 2 (6 Months): Number of Participants With Related SAEs and TEAEs Associated With Infusions Participants With Related TEAEs Associated With Infusions	9 Participants	5 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP. TEAEs caused in Epoch 1 were defined as AEs that occurred on or after the start of study drug administration, and before the first dose of IP in Epoch 2 (6 months). TEAEs caused in Epoch 2 (6 months) were defined as AEs that began during or after administration of the first dose of IP in Epoch 2 (6 months). TEAEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With TEAEs Temporally Associated With Infusions	12 Participants	6 Participants	7 Participants	4 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

Adverse reactions plus suspected ARs were defined as TEAEs that were considered by the investigator to be related to IP administration, or for which the causality was indeterminate or missing, or that began during infusion of IP or within 72 hours following the end of IP infusion. AEs temporally associated with infusions are defined as AEs occurring during or within 72 hours after completion of an infusion.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious ARs Plus Suspected ARs Temporally Associated With Infusions Participants with Serious ARs Plus Suspected ARs Temporally Associated with Infusions	0 Participants	0 Participants	0 Participants	0 Participants
Epoch 1 and 2 (6 Months): Number of Participants With Serious and Non-serious ARs Plus Suspected ARs Temporally Associated With Infusions Participants with Non-serious ARs Plus Suspected ARs Temporally Associated with Infusions	12 Participants	6 Participants	7 Participants	4 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

Any TEAEs other than local TEAEs were considered a systemic TEAE. Infusion associated TEAEs were defined as TEAE considered to be "infusion-related reactions" by investigators.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Systemic TEAEs Associated With Infusions	3 Participants	4 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

Any reaction with the medical dictionary for regulatory activities (MedDRA) high-level group term (HLGT) of "Administration site reactions" were considered a local infusion site reaction (local TEAE). In addition, any TEAE with Injection Site Reaction Flag = "Yes" was considered a local TEAE. Infusion associated reaction were defined as event considered to be "infusion-related reactions" by investigators.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Treatment-emergent Local Infusion Site Reactions Associated With Infusions	9 Participants	5 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once.

Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs were reported.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=172 Total Number of Infusions Administered TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=65 Total Number of Infusions Administered TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=100 Total Number of Infusions Administered TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=46 Total Number of Infusions Administered TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or AEs	2 infusions	0 infusions	0 infusions	1 infusions

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: SAS included all enrolled participants who received TAK-771 administration at least once. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified categories.

Plasma samples for the detection of anti-rHuPH20 binding and neutralizing antibodies were collected. Participants were monitored for the formation of anti-rHuPH20 antibodies using validated anti-rHuPH20 antibody detection assay (also known as the Screening and Confirmatory Binding Assay). Positive antibodies were defined as participants who had anti rHuPH20 antibody titer greater than or equal to (\>=) 1:160 at least one time during treatment.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 n=15 Participants TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Number of Participants With Positive Binding Antibodies, and Positive Neutralizing Antibodies to rHuPH20 Participants with Positive Antibodies	2 Participants	2 Participants	3 Participants	2 Participants
Epoch 1 and 2 (6 Months): Number of Participants With Positive Binding Antibodies, and Positive Neutralizing Antibodies to rHuPH20 Participants with Positive Neutralizing Antibodies	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Epoch 1: Baseline until end of Epoch 1 or relapse (up to 6 months)

Population: FAS included all enrolled participants who received TAK-771 at least once.

Clinical Worsening of CIDP was defined as a \>=8 kPa decrease in hand grip strength in the more affected hand OR \>=4 points decrease in Rasch Built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score at 2 consecutive time points. Hand grip strength was measured using the Martin vigorimeter by quantifying air pressure. The R-ODS was a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. R-ODS was comprised of 24 items that rate participant's functioning related to a variety of everyday tasks at moment of completion on a scale of 0 to 2 (where 0 indicates it is not possible for the respondent to perform the task and 2 means that task can be performed without difficulty). Total scores range from 0 to 48 and higher scores indicate greater ability to perform daily and social tasks.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Percentage of Participants With Clinical Worsening of CIDP	21.1 percentage of participants Interval 8.51 to 43.33	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months; Epoch 2: Up to 6 months post-Epoch 1

Population: FAS included all enrolled participants who received TAK-771 at least once.

Time to relapse was defined as time from the date of the first SC administration of TAK-771 in Epoch 1 or 2 to the date of relapse.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=19 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1 and 2 (6 Months): Time to Relapse in Participants With CIDP	NA weeks Data for median and 95% confidence interval was not estimable as less than 50% of the participants had event.	NA weeks Data for median and 95% confidence interval was not estimable as less than 50% of the participants had event.	—	—

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months

Population: FAS included all enrolled participants who received TAK-771 at least once. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

The R-ODS was a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participants with immune-mediated peripheral neuropathies including CIDP. R-ODS was comprised of 24 items that rate participant's functioning related to a variety of everyday tasks at moment of completion on a scale of 0 to 2 (where 0 indicates it is not possible for the respondent to perform the task and 2 means that task can be performed without difficulty). Total scores range from 0 to 48 and higher scores indicate greater ability to perform daily and social tasks.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=17 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) in R-ODS Total Score in Participants With CIDP	0.1 score on scale Standard Deviation 3.24	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months

The Martin Vigorimeter was used to assess grip strength in both hands. The instrument consisted of a compressible rubber ball that was connected to a manometer. When the rubber ball was squeezed, the force of compression was measured in kPa ranging from 0 to 160 kPa. Average of grip strength was defined as an average of the two maximum values: maximum of the 3 measurements in the more affected hand and the maximum of the 3 measurements in the less affected hand.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=17 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 n=7 Participants TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) in an Average of Handgrip Strength of Both Hands in Participants With CIDP and MMN	4.03 kPa Standard Deviation 9.749	-0.36 kPa Standard Deviation 10.613	—	—

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months

Population: FAS included all enrolled participants who received TAK-771 at least once.

The MRC sum score served as a measure of muscle strength. The following muscles on each side of the body were examined and the strength of each muscle was rated according to the MRC scale: deltoids, biceps, wrist extensors, iliopsoas, quadriceps, and anterior tibialis. The MRC scale ranged from 0 to 5, where: 0 = no visible contraction; 1 = visible contraction without movement of the limb; 2 = movement of the limb but not against gravity; 3 = movement against gravity over (almost) the full range; 4 = movement against gravity and resistance; and 5 = normal. All scores from both left and right side of the body were summed to obtain the total MRC sum score. The total MRC sum score ranged from 0 (paralysis) to 60 (normal strength) with higher score indication normal strength.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=7 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Change From Pre-subcutaneous Treatment (Baseline) Total Medical Research Council (MRC) Sum Score in Participants With MMN	-0.3 score on scale Standard Deviation 3.59	—	—	—

SECONDARY outcome

Timeframe: Epoch 1: Baseline up to 6 months

Population: FAS included all enrolled participants who received TAK-771 at least once.

GNDS was a questionnaire which consisted of 12 separate categories (4 to 8 questions per category). The categories included: cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and others. In the current study, only 2 categories; upper limb function and the lower limb function was used for assessment of the disability of participants with MMN. The severity of each subscale (including upper limb and lower limb) was graded from 0 (normal function) to 5 (total loss of function) based according to severity and impact on the individual. The total GNDS score was the sum of the 12 separate scores ranging between 0 and 60 with higher scores indicating loss of function.

Outcome measures

Outcome measures
Measure	Epoch 1, Cohort 1 (CIDP): TAK-771 n=7 Participants TAK-771 included Immune Globulin Infusion (IGI) 10 percent (%) and Recombinant Human Hyaluronidase (rHuPH20). Participants with CIDP received subcutaneous (SC) infusion of rHuPH20 solution at a dose of 80 units per gram (U/g) immunoglobulin G (IgG) first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1 or until relapse.	Epoch 1, Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for up to 6 months in Epoch 1.	Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with CIDP received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.	Epoch 2 (6 months), Cohort 2 (MMN): TAK-771 TAK-771 included IGI 10% and rHuPH20. Participants with MMN received SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3 or 4 weeks for 6 months in Epoch 2 (6 months). The dose and dosing interval of TAK-771 in the first 6 months of Epoch 2 were fixed as same as those in Epoch 1. At the end of the first 6 months of Epoch 2, the dosing interval of TAK-771 could be adjusted at the discretion of investigator as medically necessary.
Epoch 1: Number of MMN Participants With Increased Guy's Neurological Disability Scale (GNDS) Score in Upper Limb and Lower Limb Categories Participants with increased GNDS score in Upper Limb	1 Participants Interval 1.25 to	—	—	—
Epoch 1: Number of MMN Participants With Increased Guy's Neurological Disability Scale (GNDS) Score in Upper Limb and Lower Limb Categories Participants with Increased GNDS Score in Lower Limb	0 Participants Interval 1.57 to	—	—	—

Adverse Events

Epoch 1, Cohort 1 (CIDP): TAK-771

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Epoch 1, Cohort 2 (MMN): TAK-771

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Epoch 2 (6 months), Cohort 1 (CIDP): TAK-771

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Epoch 2 (6 months), Cohort 2 (MMN): TAK-771

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place