A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Normal human immunoglobulin G administered intravenously
Phoenix Children's Hospital
Phoenix, Arizona, United States
COMPLETEDChildren's Hospital of Los Angeles
Los Angeles, California, United States
WITHDRAWNUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
CIDP relapse, defined as a clinical decline relative to the previous assessment as indicated by an increase in modified Rankin Scale (mRS) of ≥ 1 point, in the Randomized Phase
Time frame: Approximately 24 weeks
Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level
Time frame: Approximately 56 weeks
Rate of TEAEs per infusion
Time frame: Approximately 56 weeks
Rate of mild, moderate, and severe TEAEs per infusion by dose level
Time frame: Approximately 56 weeks
Percentage of subjects with serious TEAEs
Time frame: Approximately 56 weeks
Rate of serious TEAEs per infusion
Time frame: Approximately 56 weeks
Percentage of subjects with related TEAEs
Time frame: Approximately 56 weeks
Rate of related TEAEs per infusion
Time frame: Approximately 56 weeks
Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase
Time frame: Approximately 24 weeks
Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase
The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death)
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Akron Children's Hospital
Akron, Ohio, United States
WITHDRAWNChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGLe Bonheur Children's Hospital
Memphis, Tennessee, United States
WITHDRAWNNeurology Rare Disease Center
Denton, Texas, United States
RECRUITINGChildren's Specialty Group
Norfolk, Virginia, United States
COMPLETEDSeattle Children's Hospital
Seattle, Washington, United States
RECRUITINGTime frame: Baseline and Approximately 24 weeks
Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level
CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit
Time frame: Approximately 24 weeks
Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level
CIDP recovery in the Randomized Phase, defined as decrease in mRS score as comparedto baseline AND mRS score of 1 or 0 at end of Randomized Phase
Time frame: Approximately 24 weeks
Time to CIDP relapse in Randomized Phase by dose level
Time frame: Approximately 24 weeks
Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level
CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline
Time frame: Approximately 24 weeks
Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level
CIDP recovery in the Dose Exploration Phase, defined as decrease in mRS score compared to baseline AND mRS score of 1 or 0 at end of DEP
Time frame: Approximately 24 weeks
Time to CIDP Relapse in the Dose Exploration Phase by dose level
Time frame: Approximately 24 weeks