A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system attacks itself. In CIDP, the immune system attacks the protective covering around the nerves called myelin. Over time, these nerves lose their ability to send signals to the muscles in the body. This leads to muscle weakness and loss of sensation in arms and legs among other symptoms. Participants with CIDP can be treated with a protein called immunoglobulin (or IG).
TAK-411 is a special type of immune globulin G (hsIgG) that has been chemically changed. It is made from IG that comes from human plasma. This study will test if TAK-411 can decrease inflammation and improve symptoms of CIDP.
The main aim of this study is to check how TAK-411 affects the physical functioning of adults with CIDP when compared with results of the placebo group of a historical trial.
Participants may be treated with TAK-411 for up to 1 year (51 weeks) and will be followed up for 3 weeks after last dose.
During the study, participants may visit their study clinic up to approximately 21 times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant is at least 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
The participant has a body weight of less than or equal to (<=) 150 kilogram (kg).
The participant has a documented diagnosis of typical CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and consistent with the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021 criteria.
The participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits).
Disqualifiers
The participant has a documented diagnosis of a CIDP variant per EAN/PNS 2021 criteria.
Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy, Charcot-Marie-Tooth disease, and hereditary sensory and autonomic neuropathies.
Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and nondiabetic lumbosacral radiculoplexus neuropathy, lymphoma, amyloidosis.
Multifocal motor neuropathy.
Trial design
Design model
Single group
Treatments tested in this trial
TAK-411
Biological/VaccineTAK-411 IV infusion.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: TAK-411Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Improvement in Functional Ability at Week 24
Improvement in functional ability is defined as decrease of \>=1 point in INCAT score at Week 24 compared with baseline (last assessment before first investigational product \[IP\] administration on Day 1). INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Time frame
At Week 24Secondary outcomes
1
Number of Participants With Improvement in Functional Ability at Weeks 12 and 54
Improvement in functional ability is defined as decrease of \>=1 point in the adjusted INCAT score at 12 and 54 weeks compared with baseline (last assessment before first IP administration on Day 1). INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Time frame
At 12 and 54 weeks2
Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Time frame
Baseline (last assessment prior first dose on Day 1), at 12, 24 and 54 weeks3
Change From Screening in the Adjusted INCAT Score
INCAT disability scale consists of upper and lower extremity components, which are scored based on a participant's level of impairment/disability in their arms and legs, respectively. Each component is scored from 0 to 5 points, which are summed for an overall INCAT disability score ranging from 0 to 10 points, where a score of 0 indicates no signs of disability (example, no upper limb problems and walking not affected) and a score of 10 indicates most severe disability (example, inability to move either arm for any purposeful movement and restricted to a wheelchair, unable to stand and walk a few steps with help). Adjusted INCAT disability score remains identical to INCAT disability score, except that changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded.
Time frame
Screening, at 12, 24 and 54 weeks4
Number of Participants With Improvement in Functional Ability on Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score
Improvement in functional ability defined as increase of greater than or equal to (\>=) 4 points in the raw summed I-RODS score at 12, 24, and 54 weeks compared with baseline. I-RODS is a validated, participants-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. 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. A total I-RODS score of 0 (complete disability) to 48 (no disability) is tabulated by totalling the 24-item responses where higher score represents better outcomes.
Time frame
At 12, 24 and 54 weeks Source ClinicalTrials.gov