Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections

NCT07220915 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: NGAM-16
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy

Conditions

Hypogammaglobulinemia; Autoimmune Conditions; Rheumatic Conditions; Infections

Outcome Measures

Primary Outcomes (1)

• Occurrence of Major Infections in Participants

  Occurrence of at least one major infection or death in patients with or without primary infection prophylaxis with Panzyga during the treatment period. Each potential infection will be assessed by an Independent Adjudication Committee (IAC). Major infections will be defined as bacterial and/or viral infections, which are microbiologically documented or clinically documented requiring treatment with anti-infective, including those resulting in death, excluding confirmed cases of COVID-19.

  48 weeks

Secondary Outcomes (3)

• Time to Major Infections in Participants

  48 weeks

• Number of Participants Experiencing AEs

  48 weeks

• Participants Experiencing Changes from Baseline in Physical Examinations, and Clinical Laboratory Parameters

  48 Weeks

Study Arms (2)

Panzyga 10%

ACTIVE COMPARATOR

Panzyga is a 10% Ig formulation for intravenous (IV) administration. The product is delivered as a ready-to-use solution in glass bottles. Patients in the Panzyga treatment arm will receive 0.4 g/kg (4 mL/kg) per single infusion every 4 weeks for up to 48 weeks (up to 13 infusions). In the open-label phase patients will receive Panzyga 0.4 g/kg. If 3-4 weeks after the first open-label infusion the IgG trough level falls below 7 g/L, the dose will be increased to 0.6 g/kg. Additionally, the dose may be increased to 0.6 g/kg if a patient experiences one more major infection, or ≥2 other (non-major) infections.

Drug: Panzyga, 10% Intravenous Solution

Placebo

PLACEBO COMPARATOR

4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion every 4 weeks for up to 48 weeks (up to 13 infusions).

Other: Placebo

Interventions

Panzyga, 10% Intravenous Solution DRUG

Panzyga is a 10% Ig formulation for intravenous (IV) administration

Panzyga 10%

Placebo OTHER

4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients who meet all of the following criteria will be eligible to participate in the study:
• Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.
• Have hypogammaglobulinemia (IgG levels \<5 g/L as confirmed by the central laboratory).
• Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..
• Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from participation in the study:
• Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component
• Have a current major infection at Screening or had \>1 major infection within 6 months prior to Baseline
• Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline
• Have a known IgA deficiency with antibodies to IgA
• Have a known blood hyperviscosity or other hypercoagulable states
• Have been diagnosed with primary immunodeficiency.
• Have a severe liver disease, with signs of ascites or hepatic encephalopathy
• Have a severe kidney disease (as defined by eGFR \<30 mL/min/1.73 m2)
• Have a body weight \>140 kg
• HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV- 1/2 antigen/antibody immunoassay followed by positive HIV-1/HIV-2 antibody differentiation immunoassay)
• Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.
• Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).
• Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study
• Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration

Sponsors & Collaborators

• Octapharma: lead

MeSH Terms

Conditions

Agammaglobulinemia; Infections

Interventions

Panzyga

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Patrick Murphy

CONTACT

413-821-0022; p.murphy@crmg-usa.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share