IVIG vs SCIG in CIDP

NCT05584631 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro2019001038
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.

Conditions

CIDP; Immunoglobulin Deficiency; Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

immunoglobulin; pharmacokinetics; obesity

Outcome Measures

Primary Outcomes (3)

• Assessment of drug half-life

  Calculation of drug half-life based on data obtained from serum samples

  Through study completion, an average of 4 weeks

• Assessment of immune globulin G serum concentration after intravenous immune globulin G administration

  Serum IgG concentration (including subtype) will be measured using a human IgG ELISA kit

  Just before drug administration, immediately after drug administration, approximately days 7 and 14 post drug administration

• Assessment of immune globulin G serum concentration after subcutaneous immune globulin G administration

  Serum IgG concentration (including subtype) will be measured using a human IgG ELISA kit

  Just before drug administration, immediately after drug administration, approximately days 2, 4 and 7 post drug administration

Secondary Outcomes (4)

• Assessment of grip strength

  Baseline and just before administration of next immune globulin dose.

• Assessment of muscle function

  Baseline and just before administration of next immune globulin dose.

• Assessment of patient disability

  Baseline and just before administration of next immune globulin dose.

• Assessment of fatigue

  Baseline and just before administration of next immune globulin dose.

Study Arms (2)

Intravenous immune globulin G

EXPERIMENTAL

Subjects will receive there current intravenous immune globulin dose.

Drug: Intravenous immune globulin G

Subcutaneous immune globulin G

EXPERIMENTAL

The dosage will be converted from the subject's current intravenous immune globulin G dosage 1:1 (gm per gm).

Drug: Subcutaneous immune globulin G

Interventions

Subcutaneous immune globulin G DRUG

Subcutaneous immune globulin G converted from the subject's current IVIG dose 1:1.

Also known as: Hizentra, SCIG

Subcutaneous immune globulin G

Intravenous immune globulin G DRUG

Intravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP.

Also known as: Privigen, IVIG

Intravenous immune globulin G

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria).
• :1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG.

You may not qualify if:

• Patients receiving IVIG for indications other than CIDP will be excluded.
• Patients with liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal) or reduced renal function (CrCl \< 50 mL/min) will be excluded
• Active malignancies
• Diabetes
• Myasthenia gravis
• Immunodeficiency
• Autoimmune disease

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers, The State University of New Jersey Clinical Research Center

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Agammaglobulinemia; Obesity

Interventions

Immunoglobulins, Intravenous; Hizentra

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunologic Deficiency Syndromes; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Luigi Brunetti, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Brunetti, PhD

CONTACT

2016385868; brunetti@pharmacy.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 18, 2022
• Study Start: September 11, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)