NCT07346859

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

Open-label, Multicentre, Tolerability, Safety and Pharmacokinetics Study of the Medicinal Product BP-SCIG 20% (Human Normal Immunoglobulin for Subcutaneous Administration) Manufactured by BIOPHARMA PLASMA LLC, Followed by an Efficacy Assessment of Long-term Use in Patients With Primary Immunodeficiency (PID)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Biopharma Plasma LLC · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The clinical trial will consist of three periods, namely: screening period: lasting up to 2 months, and involving three screening visits; treatment period (from Cycle 1 visit \[the first 4 administrations of the IMP are to be performed in a hospital setting\] during the 52 weeks to the last visit of Cycle 13). follow-up period after completion of the last cycle of the treatment period, with a duration of 1 week.

Conditions

• Primary Immunodeficiency Diseases

Interventions

Type	Name	Description
DRUG	BP-SCIG 20%	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.

Timeline

• Start date: 2025-12-17
• Primary completion: 2028-04-17
• Completion: 2028-07-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

12 sites across 1 country: Ukraine