This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Safety outcomes based on adverse event (AE) monitoring and other safety assessments
Time frame: 16 weeks
Time to the first retreatment with IVIg since the final IVIg treatment of the IVIg monitoring period
Time frame: 16 weeks
AUC (area under curve) of the change from baseline in mMRC (modified Medical Research Council)-10 sum score
Time frame: 16 weeks
Change from baseline in the average score of the 2 most important muscle groups as assessed by the mMRC (modified Medical Research Council)-14 sum score
Time frame: 16 weeks
Value baseline in the mMRC (modified Medical Research Council)-14 sum score
Time frame: 16 weeks
Change from baseline in the mMRC (modified Medical Research Council)-14 sum score
Time frame: 16 weeks
Proportion of participants showing a deterioration of 1 or more points in at least 2 muscle groups as assessed by the mMRC (modified Medical Research Council)-14 sum score
Time frame: 16 weeks
Proportion of participants with no deterioration in 2 or more muscle groups as assessed by mMRC (modified Medical Research Council)-14 sum score
Time frame: 16 weeks
AUC (area under curve) of the change from baseline in GS (grip strength)
Time frame: 16 weeks
Proportion of participants with a GS (grip strength) decrease of 8 kilopascal (kPa) or more over 3 consecutive days
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HonorHealth Research Institute-Neuroscience Research
Scottsdate, Arizona, United States
California Pacific Medical Center-Forbes Norris MDA/ALS Research Center
San Francisco, California, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
HonorHealth Research Institute-Neuroscience Research
Maitland, Florida, United States
University of South Florida Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States
NorthShore University HealthSystem
Glenview, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Minnesota Delware Clinic Research Unit
Minneapolis, Minnesota, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
...and 30 more locations
Time frame: 16 weeks
Values baseline in GS (grip strength)
The baseline for the grip strength is a 3-day moving average per hand, measured as an average of 3 contractions daily, each lasting 3 seconds. Measurement of GS will be done using the Martin vigorimeter in kPa.
Time frame: 16 weeks
Change from baseline in GS (grip strength)
The baseline for the grip strength is a 3-day moving average per hand, measured as an average of 3 contractions daily, each lasting 3 seconds. Measurement of GS will be done using the Martin vigorimeter in kPa.
Time frame: 16 weeks
Percent change from baseline in GS (grip strength)
The baseline for the grip strength is a 3-day moving average per hand, measured as an average of 3 contractions daily, each lasting 3 seconds. Measurement of GS will be done using the Martin vigorimeter in kPa.
Time frame: 16 weeks
Values baseline in the Rasch-built overall disability scale for MMN (MMN-RODS©)
Time frame: 16 weeks
Change from baseline in the Rasch-built overall disability scale for MMN (MMN-RODS©)
Time frame: 16 weeks
Values baseline in the average time for upper extremity (arm and hand) function (9-Hole Peg Test [9-HPT], or timed Peg Board Test)
Time frame: 16 weeks
Change from baseline in the average time for upper extremity (arm and hand) function (9-Hole Peg Test [9-HPT], or timed Peg Board Test)
Time frame: 16 weeks
Proportion of participants by level of severity on each dimension of the EQ-5D-5L scale
Time frame: 16 weeks
Change from baseline in quality of life using EQ-5D-5L visual analog scale
Time frame: 16 weeks
Change from baseline in the chronic acquired polyneuropathy patient-reported index (CAP-PRI)
Time frame: 16 weeks
Serum titer levels of binding antibodies (BAbs) against ARGX-117
Time frame: 16 weeks
Change from baseline in free C2, total C2, functional complement activity (CH50)
Time frame: 16 weeks
Values baseline in free C2, total C2, functional complement activity (CH50)
Time frame: 16 weeks
Area Under The Curve (AUC)
Time frame: 16 weeks
Maximum serum concentrations (Cmax)
Time frame: 16 weeks