Efficacy and Safety and Pharmacokinetics of Boya IVIG

NCT06150833 | Unknown Phase 3 DMC

• 1 other identifier: BoyaIVIG
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety, efficacy and pharmacokinetic properties of Boya's IVIG preparation in participants with PID aged less than 60 years and more than 6 years.

Conditions

Primary Immunodeficiency Disease

Keywords

BOYA; IVIG; PID

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Objective (average of acute serious bacterial infections)

  The incidence of serious bacterial infections (septicemia, meningitis, visceral abscess, osteomyelitis, and pneumonia) within the 1-year follow-up is less than 1.0 per patient/year in the average of the population.

  Between Visit 0 and Final Visit (through study completion, an average of 1 year)

Secondary Outcomes (4)

• Assessment of the rate of non-serious infections within one year

  Average incidence of non-serious infections per patient between Visit 0 and Final Visit (through study completion, an average of 1 year), as documented as treatment emergent adverse events (TEAEs).

• Length of infections

  Average number of days for treating infections per patient between visit 0 and final visit (through study completion, an average of 1 year), as documented as treatment emergent adverse events (TEAEs)

• Missing time from school/work

  Average number of days off from school/work per patient/month, as documented in the patient's diary (through study completion, an average of 1 year)

• Hospitalization episodes

  Number of days hospitalized per month overall and due to infection, as documented as treatment emergent adverse events - TEAEs (through study completion, an average of 1 year)

Other Outcomes (8)

• Secondary Pharmacokinetic (PK) Objectives

  9 months

• Secondary Pharmacokinetic (PK) Objectives

  28 days

• IgG half-life

  28 days

Study Arms (1)

Boya IVIG

EXPERIMENTAL

Patients with primary immunodeficiency will switch to Boya IVIG and optimize the posology in a run-in period of 2 to 6 administrations. In the one-year test period, the patients will receive the test IVIG at 21- or 28-day intervals and be followed. The minimum IgG concentration will be measured in all participants at all visits. The other pharmacokinetic parameters will be measured between visits 4 and 5 in 20 adult participants by taking additional blood samples. An independent Safety Data Monitoring Committee (SDMC) will periodically monitor adverse events.

Biological: Boya IVIG

Interventions

Boya IVIG BIOLOGICAL

The initial dose and other dose changes will be determined by the investigator on a case-by-case basis aiming to prevent infection and minimum serum IgG levels of 5 g/L. The total number of doses administered will depend on the treatment regimen and run-in period: * Between 16 and 20 intravenous injections for participants receiving infusions every 28 days, or; * Between 21 and 25 intravenous injections for participants receiving infusions every 21 days

Also known as: IVIG, BOYA

Boya IVIG

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signature of written informed consent.
• Men or women.
• Age ≤ 60 years.
• Diagnosis of PID disease (PID) with a reduction in antibody production due to:
• Common variable immunodeficiency (CVID) as defined ESID/PAGID, OR
• X-linked agammaglobulinemia (XLA) as defined by ESID/PAGID.
• Receiving intravenous immunoglobulin replacement therapy at 21- or 28-day intervals at 300 to 600 mg/kg/month for a minimum of 2 months prior to study entry.
• Absence of episodes of serious bacterial infections with prior use of IV immunoglobulin for at least 3 months prior to screening.
• Negative pregnancy test (in female participants of childbearing potential); readiness to use reliable contraceptive methods throughout the study period.
• Patients who have participated in a clinical study with another investigational IVIG may be included if they have a potential benefit in accordance with CNS Res. 251/1997.
• Participants undergoing treatment with any subcutaneous or intramuscular immunoglobulin may be included by switching to IVIG therapy at the discretion of the investigator, considering the possible benefit to the participant.

You may not qualify if:

• Known intolerance or hypersensitivity to immunoglobulins or components of the test article;
• Any contraindications to the use of immunoglobulins;
• Secondary immunodeficiency or conditions potentially causing secondary immunodeficiency such as chronic lymphoid leukemia, lymphoma, multiple myeloma, protein-losing enteropathies or nephropathies, and hypoalbuminemia;
• Clinically relevant changes in the safety exams are defined as:
• Blood count
• Hb \< 10.5 g/dL
• Leukocytes \< 3,000 / mm3 or \>10,000 cells / mm3
• Absolute neutrophil count \< 1,000 cells/mm3;
• Coagulation
• TP and aPTT \> 2.5 x ULN
• Biochemistry
• glycated hemoglobin \> 6.5%
• total bilirubin and fractions, alkaline phosphatase, ALT, AST, GGT \> 2.5 x ULN
• creatinine above 3mg/dl or creatinine clearance \< 30mL/min
• Urine I.

Sponsors & Collaborators

• Azidus Brasil: lead
• Boya Bio Pharmaceutical Group Co Ltd: collaborator

Related Publications (35)

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MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Luciana Ferrara

  Azidus Brasil

  STUDY DIRECTOR

Central Study Contacts

Luciana Ferrara

CONTACT

+55 19 981428814; luciana.ferrara@azidusbrasil.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: The trial will be open-label and single-arm. Therefore, there will be no randomization or blinding.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with primary immunodeficiency will switch to Boya IVIG and optimize the posology in a run-in period of 2 to 6 administrations. In the one-year test period, the patients will receive the test IVIG at 21- or 28-day intervals and be followed. IgG trough levels will be collected from all participants, at all visits. The remaining pharmacokinetic parameters will be measured between visits 4 and 5 in 20 adult participants, collecting additional blood samples.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: April 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share