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

January 8, 2026 updated by: Biopharma Plasma LLC

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Cherkasy, Ukraine
        • Not yet recruiting
        • Municipal Non-Profit Enterprise "Cherkasy Regional Children's Hospital" of the Cherkasy Regional Council
        • Contact:
      • Chernivtsi, Ukraine, 58001
        • Recruiting
        • Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Teaching Hospital"
        • Contact:
      • Ivano-Frankivsk, Ukraine, 76008
        • Recruiting
        • Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Teaching Hospital" of the Ivano-Frankivsk Regional Council
        • Contact:
      • Ivano-Frankivsk, Ukraine
        • Not yet recruiting
        • Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Children's Teaching Hospital" of the Ivano-Frankivsk Regional Council
        • Contact:
      • Kyiv, Ukraine, 04209
        • Not yet recruiting
        • Municipal Non-Profit Enterprise "Kyiv City Children's Teaching Hospital No. 1"
        • Contact:
      • Lutsk, Ukraine, 43000
        • Recruiting
        • LLC "Allergy and Cough Clinic"
        • Contact:
      • Lutsk, Ukraine
        • Not yet recruiting
        • Municipal Enterprise "Volyn Regional Territorial Medical Association for the Protection of Motherhood and Childhood" of the Volyn Regional Council
        • Contact:
          • Iryna Hrabovska-Mykytiuk, Paediatric Immunologist
          • Phone Number: +380977910285
          • Email: grabovska_i.m@ukr.net
      • Lviv, Ukraine, 79010
        • Recruiting
        • Municipal Non-Profit Enterprise of the Lviv Regional Council "Lviv Regional Teaching Diagnostic Centre"
        • Contact:
          • Valentyna Chopiak, Doctor of Medical Sciences
          • Phone Number: +38032 2756142
          • Email: chopyakv@ukr.net
      • Lviv, Ukraine, 79035
        • Not yet recruiting
        • Municipal Non-Profit Enterprise of the Lviv Regional Council "Clinical Centre of Children's Medicine", structural unit "West Ukrainian Specialised Centre"
        • Contact:
      • Rivne, Ukraine, 33017
        • Recruiting
        • Municipal Non-Profit Enterprise "Central Municipal Hospital" of Rivne City Council
        • Contact:
          • Nataliia Kozliuk, Clinical immunologist
          • Phone Number: +380666583618
          • Email: kozlyukn@ukr.net
      • Vinnytsia, Ukraine, 21018
        • Not yet recruiting
        • Municipal Non-Profit Enterprise "Vinnytsia Regional Teaching Hospital named after M.I. Pyrohov" of the Vinnytsia Regional Council
        • Contact:
          • Olha Bondarchuk, Clinical Immunologist
          • Phone Number: +380677843933
          • Email: imunolga@ukr.net
      • Vinnytsia, Ukraine
        • Not yet recruiting
        • Municipal Non-Profit Enterprise "Vinnytsia Regional Children's Teaching Hospital" of the Vinnytsia Regional Council
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;
  • absence of episodes of serious bacterial infections (bacteraemia or sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, visceral abscess) while taking the previous medicinal product and absence of episodes of hospitalisation for at least 3 months prior to inclusion in the study and during the screening period (prior to the first administration of the IMP BP-SCIG 20%);
  • 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.

Exclusion Criteria:

  • 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;
  • exclusion based on screening results, including emergence of episodes of serious bacterial infections while receiving a previous IV immunoglobulin product and episodes of hospitalisation during the screening period (before the first administration of the IMP BP-SCIG 20%).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single group receiving BP-SCIG20%
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%

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Plasma Concentration of Total IgG at Steady State
Time Frame: From baseline through 12 months of treatment
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
Time Frame: From baseline through 12 months of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fraction of patients reaching IgG ≥5 g/L
Time Frame: From baseline through 12 months of treatment
Percentage of patients achieving serum IgG ≥5 g/L prior to scheduled infusion.
From baseline through 12 months of treatment
Incidence of non-serious infections
Time Frame: From baseline through 12 months of treatment
Number of non-serious infectious disease episodes per patient per year
From baseline through 12 months of treatment
Duration of non-serious infections
Time Frame: From baseline through 12 months of treatment
Total duration of non-serious infections per patient per year.
From baseline through 12 months of treatment
Antibiotic use
Time Frame: From baseline through 12 months of treatment
Fraction of patients receiving antibiotics and mean number of days of antibiotic therapy per year.
From baseline through 12 months of treatment
Hospital admissions due to infection
Time Frame: From baseline through 12 months of treatment
Number and duration of hospital admissions due to infection per patient per year.
From baseline through 12 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biopharma Plasma LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2025

Primary Completion (Estimated)

April 17, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-SCIg-BP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Immunodeficiency Diseases

Clinical Trials on BP-SCIG 20%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe