A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Multifocal Motor Neuropathy (MMN)
- Interventions
- Drug: TAK-771
- Registration Number
- NCT05084053
- Lead Sponsor
- Takeda
- Brief Summary
The main aim of the study is to check for side effects from TAK-771, and to check how well TAK-771 controls symptoms in Japanese participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN)
The participants will be treated with TAK-771 for 45 months as a maximum.
There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 2, 3, or 4 weeks).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 2: TAK-771 for MMN Participants TAK-771 TAK-771 includes IGI 10% and rHuPH20. Participants will receive subcutaneous 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 2, 3, or 4 weeks. Cohort 1: TAK-771 for CIDP Participants TAK-771 TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous 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 2, 3, or 4 weeks.
- Primary Outcome Measures
Name Time Method Change in Maximum Grip Strength in the More Affected Hand in Epoch 1 for Participants with MMN 6 Months Change in maximum grip strength in the more affected hand in Epoch 1 for participants with MMN will be reported. Per baseline measurement point, investigators will judge which of both hands is more affected.
Percentage of Participants with CIDP who Experienced Relapse in Epoch 1 6 Months Relapse is 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 is the most widely used assessment tool to measure the functional activity level of patients with CIDP. The INCAT disability scale consists 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 are summed for an overall INCAT disability score ranging from 0 to 10 points, where 0 is normal and 10 is severely incapacitated. An adjusted INCAT disability score is 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.
- Secondary Outcome Measures
Name Time Method Number of Participants with Serious and Nonserious Adverse Reactions (ARs) plus Suspected ARs 45 Months Number of Participants with Treatment-emergent Adverse Events (TEAEs) 45 Months Number of Participants with Serious Adverse Events (SAEs) 45 Months Number of Participants with Treatment-emergent Local Infusion Site Reactions Associated with Infusions 45 Months Number of Participants with SAEs Associated with Infusions 45 Months Number of Participants who Have Positive Titer (>=160) Binding Antibodies, or Neutralizing Antibodies, to rHuPH20 45 Months Number of Participants with AEs Temporally Associated with Infusions 45 Months AEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion.
Number of Participants with TEAEs Associated with Infusions 45 Months Number of Participants with Serious and Nonserious ARs plus Suspected ARs Associated with Infusions 45 Months Medical Research Council (MRC) Sum Score in Epoch 1 for Participants with MMN 6 Months The MRC sum score will serve as a measure of muscle strength. The following muscles on each side of the body are examined and the strength of each muscle is rated according to the MRC scale: deltoids, biceps, wrist extensors, iliopsoas, quadriceps, and anterior tibialis. The MRC scale ranges 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 are summed to obtain the MRC sum score. The MRC sum score ranges from 0 (paralysis) to 60 (normal strength).
Number of Participants with Treatment-emergent Systemic AEs Associated with Infusions 45 Months Guy's Neurological Disability Scale (GNDS) in Upper Limb and Lower Limb Categories in Epoch 1 for Participants with MMN 6 Months Guy's Neurological Disability Scale is a questionnaire which consists of 12 separate categories (4 to 8 questions per category). The categories include: 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 will be used for assessment of the disability of participants with MMN. The severity of each subscale is graded from 0 (normal function) to 5 (total loss of function) based according to severity and impact on the individual.
Number of Infusions for which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped due to Intolerability and/or AEs 45 Months Percentage of Participants with CIDP who Experienced Worsening in Epoch 1 6 Months Worsening defined as a \>=8 kilo Pascal (kPa) decrease in the 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. The R-ODS is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
Time to Relapse in Participants with CIDP 45 Months Time to relapse is defined as time from the date of the first SC administration of TAK-771 to the date of relapse.
Change from Baseline in R-ODS Score in Epoch 1 for Participants with CIDP 6 Months The R-ODS is a patient self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in patients with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
Change from Baseline in an Average of Handgrip Strength of Both Hands in Epoch 1 for Participants with CIDP 6 Months Change from Baseline in an Average of Handgrip Strength of Both Hands in Epoch 1 for Participants with MMN 6 Months
Trial Locations
- Locations (23)
Asahikawa Medical Center
🇯🇵Asahikawa, Hokkaido, Japan
Tokushima National Hospital
🇯🇵Yoshinogawa, Tokushima, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Aichi, Japan
Chubu Rosai Hospital
🇯🇵Nagoya, Aichi, Japan
Fujita Health University Hospital
🇯🇵Toyoake, Aichi, Japan
St.Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Hyogo College of Medicine Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Kansai Rosai Hospital
🇯🇵Amagasaki, Hyogo, Japan
Tohoku Medical and Pharmaceutical University Hospital
🇯🇵Sendai, Miyagi, Japan
Shiga University of Medical Science Hospital
🇯🇵Otsu, Shiga, Japan
Nara Medical University Hospital
🇯🇵Kashihara, Nara, Japan
Higashimatsuyama Municipal Hospital
🇯🇵Higashimatsuyama, Saitama, Japan
National Center of Neurology and Psychiatry
🇯🇵Kodaira, Tokyo, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Toho University Omori Medical Center
🇯🇵Ota-ku, Tokyo, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan