Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)

NCT07346859 | Recruiting Phase 3

• 1 other identifier: 2024-SCIg-BP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 12

Brief Summary

All patients will receive the investigational medicinal product BP-SCIG 20%, solution for subcutaneous administration, manufactured by BIOPHARMA PLASMA LLC. A loading dose of IMP may be required (at the Investigator's decision): at least 0.2-0.5 g/kg (1.0-2.5 mL/kg) of body weight. This dose is distributed across several days, with a maximum daily dose of 0.1 to 0.15 g/kg. After achieving a steady-state (minimal) level of IgG, maintenance doses are administered at repeated intervals (approximately once a week) to achieve a cumulative monthly dose of 0.4-0.8 g/kg.

Conditions

Primary Immunodeficiency Diseases

Outcome Measures

Primary Outcomes (2)

• Trough Plasma Concentration of Total IgG at Steady State

  Mean monthly trough plasma concentration of total IgG prior to the next BP-SCIG 20% infusion, measured after 4 months of treatment and assessed over 6 months, compared with previous therapy (BIOVEN).

  From baseline through 12 months of treatment

• Number of Serious Bacterial Infections per Subject per Year

  Occurrence of less than 1 serious bacterial infection per patient per year during 52 weeks of BP-SCIG 20% treatment. Serious bacterial infection includes sepsis, bacterial pneumonia, bacterial visceral infections, bacterial meningitis, osteomyelitis/septic arthritis.

  From baseline through 12 months of treatment

Secondary Outcomes (5)

• Fraction of patients reaching IgG ≥5 g/L

  From baseline through 12 months of treatment

• Incidence of non-serious infections

  From baseline through 12 months of treatment

• Duration of non-serious infections

  From baseline through 12 months of treatment

• Antibiotic use

  From baseline through 12 months of treatment

• Hospital admissions due to infection

  From baseline through 12 months of treatment

Study Arms (1)

Single group receiving BP-SCIG20%

EXPERIMENTAL

Patients receive BP-SCIG 20% (human normal immunoglobulin, 200 mg/mL, IgG ≥95%) administered subcutaneously. Dosage: 0.4-0.8 g/kg per month, divided into weekly infusions. Duration: Long-term treatment as per study protoco

Drug: BP-SCIG 20%

Interventions

BP-SCIG 20% DRUG

Human normal immunoglobulin 200 mg/mL (including immunoglobulin G (IgG) no less than 95 %) administered subcutaneously. Distribution of immunoglobulin G subclasses in the product: IgG1: 65.6 %, IgG2: 22.1 %, IgG3:10.8 %, IgG4:1.5 % The maximum content of immunoglobulin A is 100 µg/mL.

Single group receiving BP-SCIG20%

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• a signed informed written consent of the patient/patient's parents or legally authorised representative to take part in the study;
• children from 0 to 18 years of age, of both sexes; or adult patients: males and females older than 18 years;
• a diagnosis of primary immunodeficiency with impaired antibody production document-supported according to the ESID criteria, requiring replacement therapy with immunoglobulins;
• patients with a body weight of no less than 9.1 kg;
• patients who received replacement therapy with intravenous immunoglobulin (IVIG) products at intervals from 21 to 28 days at the dose of 0.4-0.8 g/kg, for at least 4 months prior to the start of the study and have total serum IgG levels ≥5 g/L\*, which is confirmed by the results of no less than 2 measurements performed immediately before the scheduled IVIG administration after signing the ICF, or patients who received replacement therapy with subcutaneous immunoglobulin (SCIG) products at the dose of 0.4-0.8 g/kg per month, for at least 4 months prior to the start of the study, and have total serum IgG levels ≥5 g/L\*, based on the results of no less than 2 measurements performed immediately before the scheduled SCIG administration after signing the ICF; or patients with a newly established diagnosis of PID who have not yet received replacement therapy with IgG products (treatment-naïve patients) and have a serum IgG level ≤ 4 g/L;
• a negative pregnancy test (in female patients with childbearing potential); readiness to use reliable methods of contraception throughout the study period;
• patient's ability, in the Investigator's judgement, to comply with all the requirements of the study protocol.

You may not qualify if:

• at the request of the patient/patient's parents/patient's legally authorised representative at any time and for any reason;
• patient developing serious and/or unexpected AEs/ARs during the study, which require discontinuation of the product;
• blood transfusions or transfusions of blood components and products, with the exception of the IMP;
• the need to use medicinal products disallowed as part of this study;
• systematic lack of patient compliance with the treatment regimen prescribed by the Investigator;
• systematic lack of patient compliance with the procedures specified in this protocol;
• Receiving the IMP BP-SCIG 20% for less than 4 months;
• Presence of episodes of serious bacterial infections (bacteraemia or sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, visceral abscess) at the time of investigation of PK parameters.

Sponsors & Collaborators

• Biopharma Plasma LLC: lead

Study Sites (12)

Municipal Non-Profit Enterprise "Cherkasy Regional Children's Hospital" of the Cherkasy Regional Council

Cherkasy, Ukraine

NOT YET RECRUITING

Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Teaching Hospital"

Chernivtsi, 58001, Ukraine

RECRUITING

Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Teaching Hospital" of the Ivano-Frankivsk Regional Council

Ivano-Frankivsk, 76008, Ukraine

RECRUITING

Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Children's Teaching Hospital" of the Ivano-Frankivsk Regional Council

Ivano-Frankivsk, Ukraine

NOT YET RECRUITING

Municipal Non-Profit Enterprise "Kyiv City Children's Teaching Hospital No. 1"

Kyiv, 04209, Ukraine

NOT YET RECRUITING

LLC "Allergy and Cough Clinic"

Lutsk, 43000, Ukraine

RECRUITING

Municipal Enterprise "Volyn Regional Territorial Medical Association for the Protection of Motherhood and Childhood" of the Volyn Regional Council

Lutsk, Ukraine

NOT YET RECRUITING

Municipal Non-Profit Enterprise of the Lviv Regional Council "Lviv Regional Teaching Diagnostic Centre"

Lviv, 79010, Ukraine

RECRUITING

Municipal Non-Profit Enterprise of the Lviv Regional Council "Clinical Centre of Children's Medicine", structural unit "West Ukrainian Specialised Centre"

Lviv, 79035, Ukraine

NOT YET RECRUITING

Municipal Non-Profit Enterprise "Central Municipal Hospital" of Rivne City Council

Rivne, 33017, Ukraine

RECRUITING

Municipal Non-Profit Enterprise "Vinnytsia Regional Teaching Hospital named after M.I. Pyrohov" of the Vinnytsia Regional Council

Vinnytsia, 21018, Ukraine

NOT YET RECRUITING

Municipal Non-Profit Enterprise "Vinnytsia Regional Children's Teaching Hospital" of the Vinnytsia Regional Council

Vinnytsia, Ukraine

NOT YET RECRUITING

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study does not involve the distribution of patients into groups. Of patients in all age categories who meet inclusion criteria and passed the screening, and who do not meet any of the non-inclusion (exclusion) criteria, one group is formed, which will receive the investigational product.

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 16, 2026
• Study Start: December 17, 2025
• Primary Completion (Estimated): April 17, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

UA (12)