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New shot could help kids and adults fight off infections

NCT ID NCT07346859

Disease control Sponsor: Biopharma Plasma LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new antibody replacement therapy (BP-SCIG 20%) given as a weekly injection under the skin. It aims to see if it is safe and effective at preventing serious infections in people with primary immunodeficiency, a condition where the immune system cannot produce enough antibodies. About 56 children and adults will receive the treatment for a year, and researchers will measure infection rates and antibody levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BP-SCIG 20% (human normal immunoglobulin for subcutaneous injection)
What this could lead to
If successful, this could provide a new, well-tolerated option for replacing missing antibodies in people with primary immunodeficiency, helping prevent serious infections.
What could go wrong
This is a relatively small Phase 3 trial (56 participants) and the treatment requires lifelong weekly injections. It may not work for everyone, and side effects like local reactions or allergic responses are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

common variable immunodeficiency inborn error of immunity Primary Immunodeficiency Diseases

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary immunodeficiency diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • LLC "Allergy and Cough Clinic"

    RECRUITING

    Lutsk, 43000, Ukraine

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

    NOT_YET_RECRUITING

    Lutsk, Ukraine

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

    RECRUITING

    Rivne, 33017, Ukraine

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

    NOT_YET_RECRUITING

    Cherkasy, Ukraine

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

    NOT_YET_RECRUITING

    Ivano-Frankivsk, Ukraine

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

    RECRUITING

    Ivano-Frankivsk, 76008, Ukraine

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

    NOT_YET_RECRUITING

    Kyiv, 04209, Ukraine

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

    NOT_YET_RECRUITING

    Vinnytsia, Ukraine

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

    NOT_YET_RECRUITING

    Vinnytsia, 21018, Ukraine

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

    NOT_YET_RECRUITING

    Lviv, 79035, Ukraine

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

    RECRUITING

    Lviv, 79010, Ukraine

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

    RECRUITING

    Chernivtsi, 58001, Ukraine

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