Primary Immunodeficiency DiseasesPhase 3NCT07346859
Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)
A Phase 3 study testing BP-SCIG 20% in people with Primary Immunodeficiency Diseases, run by Biopharma Plasma LLC at 12 sites in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Primary Immunodeficiency Diseases
- What is being tested?
- BP-SCIG 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 12 sitesUkraine
- Study dates
- 17 Dec 2025to 1 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Ukraine12 sites, 12 recruiting
- Not yet recruiting
Municipal Non-Profit Enterprise "Cherkasy Regional Children's Hospital" of the Cherkasy Regional Council
Cherkasy
Liliia Nazarenko, Paediatric Immunologist, +380672525970, liliya.nazarenko.65@i.ua
- Recruiting
Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Teaching Hospital"
Chernivtsi, 58001
Halyna Koval, Professor of Immunology, +380505138110, koval.halyna@bsmu.edu.ua
- Recruiting
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Teaching Hospital" of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 76008
Marianna Derkach, Allergist-Immunologist, +380503732984, mariannaderkac@gmail.com
- Not yet recruiting
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Children's Teaching Hospital" of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk
Vira Semianchuk, Paediatric Immunologist, +380996337907, virasem.if@gmail.com
- Not yet recruiting
Municipal Non-Profit Enterprise "Kyiv City Children's Teaching Hospital No. 1"
Kyiv, 04209
Yurii Stepanovskyi, Paediatric Immunologis, +380963730105, yuriy_stepanovskiy@hotmail.com
- Recruiting
LLC "Allergy and Cough Clinic"
Lutsk, 43000
Oleh Yakovenko, Pulmonologist, +380505470790, Volyn_pulmo@gmail.com
- Not yet recruiting
Municipal Enterprise "Volyn Regional Territorial Medical Association for the Protection of Motherhood and Childhood" of the Volyn Regional Council
Lutsk
Iryna Hrabovska-Mykytiuk, Paediatric Immunologist, +380977910285, grabovska_i.m@ukr.net
- Recruiting
Municipal Non-Profit Enterprise of the Lviv Regional Council "Lviv Regional Teaching Diagnostic Centre"
Lviv, 79010
Valentyna Chopiak, Doctor of Medical Sciences, +38032 2756142, chopyakv@ukr.net
- Not yet recruiting
Municipal Non-Profit Enterprise of the Lviv Regional Council "Clinical Centre of Children's Medicine", structural unit "West Ukrainian Specialised Centre"
Lviv, 79035
Ihor Savchak, Paediatric Immunologist, +380679401426, doctorsavchak@gmail.com
- Recruiting
Municipal Non-Profit Enterprise "Central Municipal Hospital" of Rivne City Council
Rivne, 33017
Nataliia Kozliuk, Clinical immunologist, +380666583618, kozlyukn@ukr.net
- Not yet recruiting
Municipal Non-Profit Enterprise "Vinnytsia Regional Teaching Hospital named after M.I. Pyrohov" of the Vinnytsia Regional Council
Vinnytsia, 21018
Olha Bondarchuk, Clinical Immunologist, +380677843933, imunolga@ukr.net
- Not yet recruiting
Municipal Non-Profit Enterprise "Vinnytsia Regional Children's Teaching Hospital" of the Vinnytsia Regional Council
Vinnytsia
Oksana Tykholaz, Paediatric Immunologist, +38 063-318-60-35, tykholaz.ov@vnmu.edu.ua
About this study
Official title: 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.
Read the 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
- Being tested
- BP-SCIG 20%
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: BP-SCIG 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From baseline through 12 months of treatment
Secondary outcomes (5)
Fraction of patients reaching IgG ≥5 g/L
Percentage of patients achieving serum IgG ≥5 g/L prior to scheduled infusion.
Measured: From baseline through 12 months of treatment
Incidence of non-serious infections
Number of non-serious infectious disease episodes per patient per year
Measured: From baseline through 12 months of treatment
Duration of non-serious infections
Total duration of non-serious infections per patient per year.
Measured: From baseline through 12 months of treatment
Antibiotic use
Fraction of patients receiving antibiotics and mean number of days of antibiotic therapy per year.
Measured: From baseline through 12 months of treatment
Hospital admissions due to infection
Number and duration of hospital admissions due to infection per patient per year.
Measured: From baseline through 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start17 Dec 2025
- Primary completion17 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopharma Plasma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346859
- Sponsor's protocol ID
- 2024-SCIg-BP
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07346859
- Acronym / sponsor ID
- 2024-SCIg-BP
- Conditions
- Primary Immunodeficiency Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Biopharma Plasma LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single group receiving BP-SCIG20% | Experimental | Drug: BP-SCIG 20%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 |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Single group receiving BP-SCIG20% |
Primary outcome
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).
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.
5 secondary outcomes
Fraction of patients reaching IgG ≥5 g/L
Time frame: From baseline through 12 months of treatment
Incidence of non-serious infections
Time frame: From baseline through 12 months of treatment
Duration of non-serious infections
Time frame: From baseline through 12 months of treatment
Antibiotic use
Time frame: From baseline through 12 months of treatment
Hospital admissions due to infection
Time frame: From baseline through 12 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Municipal Non-Profit Enterprise "Cherkasy Regional Children's Hospital" of the Cherkasy Regional Council
Cherkasy, Ukraine
Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Teaching Hospital"
Chernivtsi, Ukraine
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Teaching Hospital" of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk, Ukraine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BP-SCIG 20% in people with Primary Immunodeficiency Diseases, run by Biopharma Plasma LLC at 12 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough Plasma Concentration of Total IgG at Steady State (time frame: From baseline through 12 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.