Clinical trial • Phase III • Immunology
HUMAN NORMAL IMMUNOGLOBULIN for Hypogammaglobulinemia | Autoimmune disease | Rheumatic disease
Phase III trial of HUMAN NORMAL IMMUNOGLOBULIN for Hypogammaglobulinemia | Autoimmune disease | Rheumatic disease.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Hypogammaglobulinemia | Autoimmune disease | Rheumatic disease
- Trial Stage
- Phase III
- Drug Modality
- Other antibody
Key dates
- Initial CTIS Submission Date
- 21-01-2026
- First CTIS Authorization Date
- 11-05-2026
Trial design
Randomised, panzyga (panzyga 100 mg/ml solution for infusion; active substance: human normal immunoglobulin) versus placebo (isotone kochsalz-lösung 0,9 % braun infusionslösung). route: intravenous. dosing units provided: millilitre(s)/kilogram; max daily amount 4 (ml/kg); max total amount 52 (ml/kg).-controlled Phase III trial in Bulgaria, Germany, Greece and others.
- Randomised
- Yes
- Comparator
- Panzyga (Panzyga 100 mg/ml solution for infusion; active substance: human normal immunoglobulin) versus placebo (Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung). Route: intravenous. Dosing units provided: millilitre(s)/kilogram; max daily amount 4 (ml/kg); max total amount 52 (ml/kg).
- Target Sample Size
- 195
Eligibility
Recruits 195 The trial flags vulnerable population selection (isVulnerablePopulationSelected: true). All participants must be ≥18 years and provide voluntary written informed consent. Exclusion criteria specify exclusion of subjects "unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator". Subject information and informed consent forms (ICFs) and related materials are provided (multiple ICF documents listed in different languages and ICF addenda), and there are specific ICFs for pregnant participants and caregiver/partner ICFs in some country-specific document sets..
- Pregnancy Exclusion
- 16. If female, are pregnant or lactating
- Vulnerable Population
- The trial flags vulnerable population selection (isVulnerablePopulationSelected: true). All participants must be ≥18 years and provide voluntary written informed consent. Exclusion criteria specify exclusion of subjects "unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator". Subject information and informed consent forms (ICFs) and related materials are provided (multiple ICF documents listed in different languages and ICF addenda), and there are specific ICFs for pregnant participants and caregiver/partner ICFs in some country-specific document sets.
Inclusion criteria
- {"criterion_text":"- 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 trial participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, Sjogren’s syndrome, idiopathic inflammatory myopathy, mixed connective tissue disease, undifferentiated connective tissue disease, 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."}
- {"criterion_text":"- 2. Have hypogammaglobulinemia (IgG levels <5 g/L as confirmed by the central laboratory)."}
- {"criterion_text":"- 3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements"}
- {"criterion_text":"- 4. Are willing and able to comply with an acceptable effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of child-bearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}
Exclusion criteria
- {"criterion_text":"- 1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component"}
- {"criterion_text":"- 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)"}
- {"criterion_text":"- 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."}
- {"criterion_text":"- 12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR)."}
- {"criterion_text":"- 13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study"}
- {"criterion_text":"- 14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration"}
- {"criterion_text":"- 15. Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product (IMP) 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."}
- {"criterion_text":"- 16. If female, are pregnant or lactating"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 2. Have a current major infection at Screening or had >1 major infection within 6 months prior to Baseline"}
- {"criterion_text":"- 3. Have a history of thromboembolic events such as deep vein thrombosis (DVT), pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline"}
- {"criterion_text":"- 4. Have a known IgA deficiency with antibodies to IgA"}
- {"criterion_text":"- 5. Have a known blood hyperviscosity or other hypercoagulable states"}
- {"criterion_text":"- 6. Have been diagnosed with primary immunodeficiency"}
- {"criterion_text":"- 7. Have a severe liver disease, with signs of ascites or hepatic encephalopathy"}
- {"criterion_text":"- 8. Have a severe kidney disease (as defined by eGFR <30 mL/min/1.73 m2)"}
- {"criterion_text":"- 9. Have body weight >140 kg"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of at least one major infection or death in patients with or without primary infection prophylaxis with Panzyga. Major infections will be recorded throughout the study along with the type and severity of infection and time to resolution. Each patient will be counted only once for the primary endpoint calculation. Each potential infection will be assessed by an Independent Adjudication Committee (IAC) consisting of clinical experts.","definition_or_measurement_approach":"Major infections recorded throughout the study with type, severity and time to resolution; each patient counted once; each potential infection assessed by an Independent Adjudication Committee (IAC)."}
Secondary endpoints
- {"endpoint_text":"- 1. Efficacy Endpoint: The time to first major infection (as assessed by the IAC) or death.","definition_or_measurement_approach":"Time-to-event (time to first major infection or death), infections assessed by the IAC."}
- {"endpoint_text":"- 2. Safety Endpoint: Incidence of AEs","definition_or_measurement_approach":"Incidence (frequency) of adverse events recorded during the study."}
- {"endpoint_text":"- 3. Safety Endpoint: Changes from Baseline in physical examinations, and clinical laboratory parameters.","definition_or_measurement_approach":"Assessment of changes from baseline in physical examination findings and clinical laboratory parameters."}
Recruitment
- Planned Sample Size
- 195
- Recruitment Window Months
- 36
- Consent Approach
- Participants must be willing and able to provide voluntary written informed consent (inclusion criterion). Subject information sheets and informed consent forms (ICFs) are provided (multiple L1 SIS and ICF documents listed across countries and languages). ICFs include main ICFs, PK addendum ICFs, pregnant participant ICFs and country/language-specific ICF versions; documents indicate availability in multiple languages (EN, BG, GR, LT, LV, RU, IT, PL, CZ etc). Participation restricted to adults (≥18 years).
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 195
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 04-05-2026
- Latest Decision Or Authorization Date
- 14-05-2026
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Rheumatology clinic
- Principal Investigator Name
- Krasimir Kraev
- Principal Investigator Email
- dr.krasimir.kraev@gmail.com
- Contact Person Name
- Krasimir Kraev
- Contact Person Email
- dr.krasimir.kraev@gmail.com
- Site Name
- Medical Center Artmed Ltd.
- Department Name
- -
- Principal Investigator Name
- Mariela Geneva-Popova
- Principal Investigator Email
- artmedcenter@yahoo.com
- Contact Person Name
- Mariela Geneva-Popova
- Contact Person Email
- artmedcenter@yahoo.com
Germany
- Earliest CTIS Part Ii Submission Date
- 04-05-2026
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Department for Nephrology
- Principal Investigator Name
- Lutz Renders
- Principal Investigator Email
- sabine.engelhardt@mri.tum.de
- Contact Person Name
- Lutz Renders
- Contact Person Email
- sabine.engelhardt@mri.tum.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Med. Klinik und Poliklinik IV Sektion Rheumatologie und klinische Immunologie – Studienambulanz
- Principal Investigator Name
- Hendrik Schulze-Koops
- Principal Investigator Email
- christina.gebhardt@med.uni-muenchen.de
- Contact Person Name
- Hendrik Schulze-Koops
- Contact Person Email
- christina.gebhardt@med.uni-muenchen.de
Greece
- Earliest CTIS Part Ii Submission Date
- 03-02-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 97
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Athens Naval Hospital
- Department Name
- Rheumatology clinic
- Principal Investigator Name
- Gkikkas Katsifis
- Principal Investigator Email
- katsifisg@yahoo.gr
- Contact Person Name
- Gkikkas Katsifis
- Contact Person Email
- katsifisg@yahoo.gr
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Nephrology department
- Principal Investigator Name
- Evangelia Ntounousi
- Principal Investigator Email
- edounous@uoi.gr
- Contact Person Name
- Evangelia Ntounousi
- Contact Person Email
- edounous@uoi.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 4th Department of Internal Medicine
- Principal Investigator Name
- Theodoros Dimitroulas
- Principal Investigator Email
- dimitroul@auth.gr
- Contact Person Name
- Theodoros Dimitroulas
- Contact Person Email
- dimitroul@auth.gr
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Rheumatology and Clinical Immunology Clinic
- Principal Investigator Name
- Prodromos Sidiropoulos
- Principal Investigator Email
- sidiropp@uoc.gr
- Contact Person Name
- Prodromos Sidiropoulos
- Contact Person Email
- sidiropp@uoc.gr
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-04-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 11
- Number Of Sites
- 5
- Number Of Participants
- 85
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Neurologická klinika 1.LF UK a VFN, Centrum pro RS a NMOSD
- Principal Investigator Name
- Jana Lízrová Preiningerová
- Principal Investigator Email
- jana.lizrova@vfn.cz
- Contact Person Name
- Jana Lízrová Preiningerová
- Contact Person Email
- jana.lizrova@vfn.cz
- Site Name
- Krajska zdravotni a.s.
- Department Name
- Neurologické oddělení, MS Centrum I
- Principal Investigator Name
- Marta Vachová
- Principal Investigator Email
- marta.vachova@kzcr.eu
- Contact Person Name
- Marta Vachová
- Contact Person Email
- marta.vachova@kzcr.eu
- Site Name
- Nemocnice Pardubickeho kraje a.s.
- Department Name
- Neurologická klinika, MS Centrum
- Principal Investigator Name
- Miroslav Mareš
- Principal Investigator Email
- info@nempk.cz
- Contact Person Name
- Miroslav Mareš
- Contact Person Email
- info@nempk.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Neurologická klinika, MS centrum
- Principal Investigator Name
- Zbyšek Pavelek
- Principal Investigator Email
- zbysek.pavelek@fnhk.cz
- Contact Person Name
- Zbyšek Pavelek
- Contact Person Email
- zbysek.pavelek@fnhk.cz
- Site Name
- NeuropsychiatrieHK s.r.o.
- Principal Investigator Name
- Martin Vališ
- Principal Investigator Email
- neuropsychiatriehk@seznam.cz
- Contact Person Name
- Martin Vališ
- Contact Person Email
- neuropsychiatriehk@seznam.cz
Italy
- Earliest CTIS Part Ii Submission Date
- 29-04-2026
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Unità Operativa di Neurologia
- Principal Investigator Name
- Massimiliano Mirabella
- Principal Investigator Email
- massimiliano.mirabella@unicatt.it
- Contact Person Name
- Massimiliano Mirabella
- Contact Person Email
- massimiliano.mirabella@unicatt.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- SSD Neurologia - Malattie Neurodegenerative
- Principal Investigator Name
- Laura Ghezzi
- Principal Investigator Email
- laura.ghezzi@policlinico.mi.it
- Contact Person Name
- Laura Ghezzi
- Contact Person Email
- laura.ghezzi@policlinico.mi.it
Latvia
- Earliest CTIS Part Ii Submission Date
- 04-05-2026
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- Neurology Clinic
- Principal Investigator Name
- Alina Flintere-Flinte
- Principal Investigator Email
- alina-medi@inbox.lv
- Contact Person Name
- Alina Flintere-Flinte
- Contact Person Email
- alina-medi@inbox.lv
- Site Name
- Riga East Clinical University Hospital
- Department Name
- Clinic "Gailezers"
- Principal Investigator Name
- Guntis Karelis
- Principal Investigator Email
- guntis.karelis@aslimnica.lv
- Contact Person Name
- Guntis Karelis
- Contact Person Email
- guntis.karelis@aslimnica.lv
Lithuania
- Earliest CTIS Part Ii Submission Date
- 15-04-2026
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Rheumatology
- Principal Investigator Name
- Regina Šakalytė
- Principal Investigator Email
- regina.sakalyte@santa.lt
- Contact Person Name
- Regina Šakalytė
- Contact Person Email
- regina.sakalyte@santa.lt
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Nephrology
- Principal Investigator Name
- Marius Miglinas
- Principal Investigator Email
- marius.miglinas@santa.lt
- Contact Person Name
- Marius Miglinas
- Contact Person Email
- marius.miglinas@santa.lt
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Neurology
- Principal Investigator Name
- Dalia Musneckienė
- Principal Investigator Email
- dalia.musneckiene@kaunoklinikos.lt
- Contact Person Name
- Dalia Musneckienė
- Contact Person Email
- dalia.musneckiene@kaunoklinikos.lt
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Neurology
- Principal Investigator Name
- Nataša Giedraitienė
- Principal Investigator Email
- natasa.giedraitiene@santa.lt
- Contact Person Name
- Nataša Giedraitienė
- Contact Person Email
- natasa.giedraitiene@santa.lt
Poland
- Earliest CTIS Part Ii Submission Date
- 30-04-2026
- Latest Decision Or Authorization Date
- 15-05-2026
- Processing Time Days
- 15
- Number Of Sites
- 3
- Number Of Participants
- 27
Sites
- Site Name
- Szpital Czerniakowski Sp. z o.o.
- Department Name
- Oddział Neurologiczny
- Principal Investigator Name
- Jarosław Pniewski
- Principal Investigator Email
- j.pniewski@op.pl
- Contact Person Name
- Jarosław Pniewski
- Contact Person Email
- j.pniewski@op.pl
- Site Name
- Copernicus Podmiot Leczniczy Sp. z o.o.
- Department Name
- Oddział Neurologiczny
- Principal Investigator Name
- Waldemar Fryze
- Principal Investigator Email
- w.fryze@wp.pl
- Contact Person Name
- Waldemar Fryze
- Contact Person Email
- w.fryze@wp.pl
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Principal Investigator Name
- Jakub Wroński
- Principal Investigator Email
- jakub.wronski@spartanska.pl
- Contact Person Name
- Jakub Wroński
- Contact Person Email
- jakub.wronski@spartanska.pl
Sponsor
Primary sponsor
- Full Name
- Octapharma Pharmazeutika Produktionsgesellschaft mbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Austria
Contract research organisations
- Name
- Medpace Ellas Monoprosopi I.K.E.
- Responsibilities
- sponsor duties codes: 1,12
- Name
- Medpace Finland Oy
- Responsibilities
- sponsor duties codes: 1,10,12,2,4,6,8
Third parties
- {"country":"Germany","full_name":"SGS Analytics Germany GmbH","duties_or_roles":"PK analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC and electronic Patient Related Outcomes (ePRO); duties codes: 15,7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Greece","full_name":"Medpace Ellas Monoprosopi I.K.E.","duties_or_roles":"sponsor duties codes: 1,12","organisation_type":"Pharmaceutical company"}
- {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsor duties codes: 1,10,12,2,4,6,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Blue Sky Elearn LLC","duties_or_roles":"Training vendor","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"SGS Analytics Germany GmbH","duties_or_roles":"PK analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"GxP Brain GmbH","duties_or_roles":"IVRS","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Adjudication Committee Endpoint assessment","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Panzyga 100 mg/ml Infusionslösung
- Active Substance
- HUMAN NORMAL IMMUNOGLOBULIN
- Modality
- Other antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 236803, authorisationCountryCode: AT)
- Maximum Dose
- max daily 4 millilitre(s)/kilogram; max total 52 millilitre(s)/kilogram
- Investigational Product Name
- Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung
- Active Substance
- SODIUM CHLORIDE
- Modality
- Other
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 6726174.00.00, authorisationCountryCode: DE)
- Maximum Dose
- max daily 4 millilitre(s)/kilogram; max total 52 millilitre(s)/kilogram
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