Hizentra (human immune globulin subcutaneous 20%) / CSL Behring - LARVOL DELTA

IVIG vs SCIG in CIDP (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Rutgers, The State University of New Jersey | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Pain

Off the Beaten Pathogen: Mycoplasma orale Joint Infection in a X-linked SCID Patient Post-transplant (ACAAI 2025) - "We report a case of a young adult male with X-linked SCID status post maternal haploidentical bone marrow transplant with poor B cell engraftment on weekly Hizentra who developed Mycoplasma orale septic arthritis...The patient was treated initially with oral levofloxacin, followed by oral doxycycline for 12 months, with improvement in symptoms and plans for a total shoulder replacement...Clinicians should include atypical pathogens such as Mycoplasma orale in the differential diagnosis when conventional cultures are negative in these patients. To our knowledge, this is the first reported case of Mycoplasma orale septic arthritis in a patient with X-linked SCID post-haploidentical transplant, highlighting the need for heightened clinical suspicion for atypical pathogens in this vulnerable population."

Clinical • Post-transplantation • Bone Marrow Transplantation • Genetic Disorders • Immunology • Infectious Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Primary Immunodeficiency • Rheumatology • Transplantation

Stones, Steatosis, and Surprises: A Rare Case of Pancreatitis in Common Variable Immunodeficiency (ACG 2025) - "This case highlights a rare co-presentation of acute pancreatitis and cholelithiasis in a young woman with CVID.Case Description/ A 26-year-old female with CVID on immunoglobulin (Hizentra), metabolic-associated cirrhosis and asthma presented with three days of diffuse abdominal pain, diarrhea, nausea, and vomiting...While gallstones caused her pancreatitis, cirrhosis and immune dysfunction likely played a role. This case emphasizes the need to maintain a broad differential in CVID patients with abdominal pain, including pancreatobiliary etiologies"

Clinical • Anemia • Asthma • Autoimmune Hemolytic Anemia • Celiac Disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Pancreatitis • Pediatrics • Primary Immunodeficiency • Respiratory Diseases

A Budget Impact Model of Treatment of Primary Immune Deficiency with Immune Globulin Subcutaneous (Human), 20% (IgPro20) (Hizentra). (PubMed, Pharmacoecon Open) - "This BIM demonstrates that uptake of subcutaneous IgPro20 PFS is expected to be associated with substantial savings for a US IDN, including drug cost savings if offset by reduced non-PFS SCIG-packaging use."

HEOR • Journal • Immunology • Primary Immunodeficiency

Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (clinicaltrials.gov) - P3 | N=16 | Terminated | Sponsor: CSL Behring | N=177 ➔ 16 | Trial completion date: Sep 2027 ➔ Jul 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2027 ➔ Jun 2025; Sponsor decision, not for safety reasons.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cardiovascular • Infectious Disease • Novel Coronavirus Disease

Unmasking the ABO Antibody Ingredient List in IVIg Preparations (WTC 2025) - "We used a LuminexTM single-antigen bead assay to measure ABO-Ab to A and B subtypes glycans to detect the ABO-Ab in commercially available IVIg products.* Thirteen IVIg lot numbers from six IVIg preparations (Privigen, Cuvirtru, Cutaquig, Hizentra, Octagram, and Gammagard Liquid) were evaluated using LuminexTM beads coupled to individual subtype ABO-A and -B glycans (subtypes I through VI)... It is valuable to know the level of ABO-Ab in IVIg for many reasons. In many clinical scenarios beyond transplantation, these ABO-Ab may cause IVIg-related red cell hemolysis. In the setting of ABO-incompatible transplantation, the presence of passively acquired ABO-Ab may interfere with the measurement of patient ABO-Ab levels pre- and post-transplant."

Hematological Disorders

Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (clinicaltrials.gov) - P3 | N=177 | Active, not recruiting | Sponsor: CSL Behring | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Infectious Disease • Novel Coronavirus Disease

Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

New P2 trial • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology

Subcutaneous Immunoglobulin (IgPro20) Dose Adjustments for Chronic Inflammatory Demyelinating Polyneuropathy Maintenance Therapy in Clinical Practice (P10-11.024). (PubMed, Neurology) - "To assess dosing of IgPro20 (immune globulin subcutaneous [human], 20% liquid, Hizentra®) in clinical practice in patients with chronic inflammatory demyelinating polyneuropathy (CIDP)...Pulley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cabaletta...Dr. Jiang has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen ."

Journal • Retrospective data • Pain

Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease (clinicaltrials.gov) - P4 | N=22 | Recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Primary Immunodeficiency • Respiratory Diseases

Subcutaneous Immunoglobulin (IgPro20) Dose Adjustments for Chronic Inflammatory Demyelinating Polyneuropathy Maintenance Therapy in Clinical Practice (AAN 2025) - "Objective:To assess dosing of IgPro20 (immune globulin subcutaneous [human], 20% liquid, Hizentra®) in clinical practice in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).Background:Subcutaneous immunoglobulin (SCIg) approved for maintenance therapy for CIDP, enables consistent Ig levels and improved quality of life compared with intravenous immunoglobulin (IVIg)...These cases demonstrate the flexibility of SCIg treatment in patients with CIDP, highlighting the importance of close follow-up to individualize SCIg therapy and achieve optimal clinical outcomes."

Clinical • Pain

RECLAIIM: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (clinicaltrials.gov) - P3 | N=126 | Terminated | Sponsor: CSL Behring | Trial completion date: May 2028 ➔ Dec 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: May 2028 ➔ Dec 2024; Primary endpoint not attained

Trial completion date • Trial primary completion date • Trial termination • Dermatomyositis • Immunology • Myositis

IgPro20 Infusion Simulation using Prefilled Syringes (AAAAI-WAO 2025) - "This human factor validation study assessed the usability of IgPro20 in Hizentra 50ml pre-filled syringe (PFS) using an infusion pump...Conclusions This study demonstrates that trained PID patients can safely and effectively administer IgPro20 from 50ml PFS. Errors were not generally attributed to design or usability of the PFS, suggesting that these issues could be addressed by providing additional training sessions."

Immunology • Primary Immunodeficiency

A Phase 2 randomised trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis. (PubMed, Rheumatology (Oxford)) - P2 | "This study shows that in patients with dcSSc, safety, pharmacokinetic and bioavailability profiles of IgPro20, and safety and pharmacokinetics of IgPro10, are similar to those observed in other approved indications."

Journal • P2 data • PK/PD data • Immunology • Scleroderma • Systemic Sclerosis

IVIG Vs SCIG in CIDP (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Rutgers, The State University of New Jersey | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ Dec 2025 | Trial primary completion date: Oct 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Pain

Indirect Treatment Comparison of Efgartigimod vs Immunoglobulins in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ISPOR-EU 2024) - "Among the studies that met the predefined criteria, an ITC was considered feasible against Privigen, Hizentra, and HyQvia. Despite the limitations of the analysis and the limited comparability of the studies, the ITC results indicate that efgartigimod has a comparable or better efficacy profile than EMA-approved immunoglobulins. Further prospective comparative studies are needed to confirm these results."

Pain

AN UNUSUAL REACTION TO HIZENTRA (SUBCUTANEOUS IMMUNE GLOBULIN (HUMAN) 20% LIQUID) (ACAAI 2024) - "Case Description: A 71-year-old female with Myasthenia Gravis on weekly 60 mg infusions of Immune Globulin Subcutaneous (Human) 20% Liquid started 2 years prior, Parkinson's Disease on Carbidopa/ Levodopa, and history of remote stress-induced urticaria, presented with 6 months of recurring, pruritic, erythematous urticarial rash on her arms and torso appearing within hours of infusions. Hizentra is a 20% solution that contains L-proline and polysorbate 80 whereas Privigen is a 10% solution with L-proline, and both have very low IgA content, <50 mcg/mL and <25 mcg/mL respectively. Urticarial Reaction to Subcutaneous Immune Globulin These recurring, pruritic, erythematous urticarial lesions were present on the arms and torso within hours of subcutaneous immune globulin infusion."

CNS Disorders • Dermatology • Immunology • Infectious Disease • Movement Disorders • Myasthenia Gravis • Novel Coronavirus Disease • Parkinson's Disease • Respiratory Diseases • Urticaria

Outcomes of a patient support programme for subcutaneous immunoglobulin therapy in patients with primary or secondary immunodeficiencies or chronic inflammatory demyelinating polyneuropathy. (PubMed, Intern Med J) - "This is the largest real-world evidence study that describes the effectiveness of SCIg PSPs across three therapeutic disease states. These PSPs can optimise hospital resources such as infusion nurse time and allocation of infusion chairs that were once used for intravenous immunoglobulin infusions, improve patient access to SCIg therapy and enable patients self-administer SCIg outside a hospital environment."

Journal • Pain

Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (clinicaltrials.gov) - P3 | N=177 | Recruiting | Sponsor: CSL Behring | Not yet recruiting ➔ Recruiting | Trial primary completion date: Feb 2027 ➔ Sep 2027

Enrollment open • Trial primary completion date • Cardiovascular • Infectious Disease • Novel Coronavirus Disease

Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (clinicaltrials.gov) - P3 | N=177 | Not yet recruiting | Sponsor: CSL Behring

New P3 trial • Cardiovascular • Infectious Disease • Novel Coronavirus Disease

RECLAIIM: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (clinicaltrials.gov) - P3 | N=126 | Active, not recruiting | Sponsor: CSL Behring | Trial completion date: Nov 2027 ➔ May 2028 | Trial primary completion date: Jun 2024 ➔ May 2028

Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis

Hizentra® in Inflammatory Neuropathies - pHeNIx Study (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: CSL Behring | Trial completion date: Sep 2024 ➔ Dec 2027 | Trial primary completion date: Sep 2024 ➔ Dec 2027

Trial completion date • Trial primary completion date • Pain

Infusion-related Costs for HyQvia Compared to Hizentra in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (AAN 2024) - "Treatment with fSCIG-10% resulted in total annual savings of $1676 per person with CIDP. Savings are attributed to less-frequent administration, resulting in fewer per-person infusion costs and nursing hours."

Immunology • Pain

Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease (clinicaltrials.gov) - P4 | N=22 | Recruiting | Sponsor: University of Alabama at Birmingham | Not yet recruiting ➔ Recruiting

Enrollment open • Primary Immunodeficiency • Respiratory Diseases

CSL Behring Announces Availability of Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe (PRNewswire) - "CSL Behring...announced the availability of a 10g prefilled syringe for Hizentra^® (Immune Globulin Subcutaneous [Human] 20% Liquid). The Hizentra prefilled syringes provide people living with Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) the ability to elevate their treatment experience by eliminating the need to draw medication from vials. CSL Behring now has a wide range of prefilled syringe sizes to help meet the individual needs of people living with PI or CIDP including a 1g, 2g, 5g and 10g."

Commercial • Immunology • Inflammation