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NCT07220915PHASE3Recruiting

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

Octapharma

Start Date

6/10/2026

Completion Date

12/1/2029

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Panzyga, 10% Intravenous Solution

OTHER

Placebo

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Conditions

HypogammaglobulinemiaAutoimmune ConditionsRheumatic ConditionsInfections

Locations

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix

Glendale, Arizona 85306

United States

AARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Mesa

Mesa, Arizona 85210

United States

Perseverance Research Center, Phoenix Neurological Associates

Scottsdale, Arizona 85253

United States

AARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Tucson

Tucson, Arizona 85704

United States

AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Fort Worth

Fort Worth, Texas 76109

United States

AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving 6750 N. MacArthur Blvd, Suite 304

Irving, Texas 75039

United States

Medical Center Artmed

Plovdiv, 4002

Bulgaria

UMHAT Sveti Georgi EAD

Plovdiv, 4002

Bulgaria

University General Hospital of Keraklion

Heraklion, 71110

Greece

P. Stradins Clinical University Hospital

Riga, 1002

Latvia

Riga East Clinical University Hospital

Riga, 1079

Latvia

Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos

Kaunas, 50161

Lithuania

Vilnius University Hospital Santaros Klinikos, Santariskiu str 2, Vilnius University Hospital Santaros Klinikos A housing, 11th floor

Vilnius, 08406

Lithuania

Vilnius University Hospital Santaros Klinikos, Santariskiu g. 2

Vilnius, 08661

Lithuania

Vilnius University Hospital Santaros Klinikos, Santariskiu str. 2,

Vilnius, 08661

Lithuania

Copernicus Podmiot Leczniczy Sp. z o.o.

Gdansk, 80803

Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warsaw, 02-637

Poland