Multicenter, Prospective, Parallel Group, Open-label, Randomized Phase III Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients

INTERVENTION: Trade Name: Panzyga Product Name: Panzyga Pharmaceutical Form: INN or Proposed INN: Panzyga Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: % percent Concentration type: equal Concentration number: 10‐ CONDITION: Chronic inflammatory demyelinating polyradiculoneuropathy Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of 2 PANZYGA dose regimens in pediatric CIDP patients based on the percentage of patients with CIDP improvement Primary end point(s): The primary efficacy endpoint of this study is the percentage (%) of patients with CIDP improvement at Week 24. CIDP improvement is defined as the following: Decrease in mRS of =1 point from the most recent score Secondary Objective: ‐ To evaluate the efficacy of 2 PANZYGA dose regimens by determining the percentage of patients with CIDP relapse.; ‐ To evaluate the safety of PANZYGA (occurrence of treatment‐emergent adverse events [TEAEs] and infusion related TEAES).; ‐ To further evaluate the efficacy of PANZYGA (including time to improvement and time to relapse and subgroup analyses).; ‐ To assess the effect of PANZYGA on the modified Rankin scale (mRS). Timepoint(s) of evaluation of this end point: Week 24 SECONDARY OUTCOME: Secondary end point(s): The secondary efficacy endpoints of this study are:; ‐ The percentage (%) of patients with CIDP relapse. CIDP relapse is defined as an increase in mRS by >1 point from most recent score.; ‐ Time to CIDP relapse or withdrawal for any other reason.; ‐ The percentage of patients with excellent response, defined by a mRS score of 0 or 1 in each arm at Week 24.; ; The secondary safety endpoints of this study are:; ‐ Occurrence of all TEAEs.; ‐ Percentage of patients with TEAEs, serious TEAEs, and related TEAEs.; ‐ Rate of TEAEs, serious TEAEs, and related TEAEs per infusion.; ‐ Rate of mild, moderate, and severe TEAEs per infusion; ‐ Short‐term tolerance variables, including vital signs.; ‐ Safety laboratory variables Timepoint(s) of evaluation of this end point: 24 weeks INCLUSION CRITERIA: 1. Age =2 years and =17 years. 2. Patients with a diagnosis of definite or probable CIDP based on European Neuromuscular Center (ENMC) criteria. 3. Clinical history of functional impairment due to CIDP, corresponding to an mRS score =2, but =5. 4. Voluntarily given written informed consent (provided by patient’s parent or legal guardian) or assent (provided by patient, if age‐appropriate per Independent Ethics Committee [IEC]/Institutional Research Board [IRB] requirements). Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range