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

NCT ID: NCT07220915

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Panzyga 10%

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.

Group Type: ACTIVE_COMPARATOR

Panzyga, 10% Intravenous Solution

Intervention Type: DRUG

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

Placebo

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Panzyga, 10% Intravenous Solution

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients who meet all of the following criteria will be eligible to participate in the study:

1. 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.

2. Have hypogammaglobulinemia (IgG levels <5 g/L as confirmed by the central laboratory).

3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..

4. 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.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participation in the study:

1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component

2. Have a current major infection at Screening or had >1 major infection within 6 months prior to Baseline

3. 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

4. Have a known IgA deficiency with antibodies to IgA

5. Have a known blood hyperviscosity or other hypercoagulable states

6. Have been diagnosed with primary immunodeficiency.

7. Have a severe liver disease, with signs of ascites or hepatic encephalopathy

8. Have a severe kidney disease (as defined by eGFR <30 mL/min/1.73 m2)

9. Have a body weight >140 kg

10. 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)

11. 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.

12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).

13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study

14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration

15. Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product within 3 months prior to Baseline or during the course of this study. Participation in observational or open-label studies involving an approved product may be permitted after consultation with the Medical Monitor.

16. If female, are pregnant or lactating

17. Are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Octapharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Patrick Murphy

Role: CONTACT

p.murphy@crmg-usa.com

413-821-0022

Other Identifiers

NGAM-16

Identifier Type: -

Identifier Source: org_study_id