Primary Immune Deficiency Diseases (PIDD)Phase 3NCT03238079
Study of PlasmaCap IG in Adults and Children With PIDD
A Phase 3 study testing 10% IGIV in people with Primary Immune Deficiency Diseases (PIDD), run by Evolve Biologics at 12 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the efficacy, safety, tolerability, and pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on the basis of historical control data, how it compares with other 10% intravenous immunoglobulin (IGIV) products currently licensed in North… Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Primary Immune Deficiency Diseases (PIDD)
- What is being tested?
- 10% IGIV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 5 Sep 2017to 25 Aug 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has a confirmed clinical diagnosis of a PIDD, which requires treatment with IGIV:
- Subject/guardian has provided written informed consent (and assent, as applicable).
- Subject is between the ages of 2 and 70 years.
- Subject has received regular IGIV therapy at 21- or 28-day (±4 days) intervals for at least three consecutive months at a dose between 300-900 mg/kg/month prior to Screening or;
- Subject has received commercial SCIG at a dose of 300-900 mg/kg/month on any dosing schedule for at least 12 consecutive weeks prior to Screening. Subjects on SCIG must have received and tolerated IGIV treatment prior to SCIG treatment.
- Subject has a documented trough of ≥500 mg/dL in the 6 months prior to screening.
- Females of childbearing potential must be willing to use an effective form of birth control (eg, oral contraceptives) for the duration of the study, per IRB/REB guidelines.
- Subject agrees to comply with the requirements of the protocol.
Who cannot join
- Subject has secondary immunodeficiency.
- Subject has history of thrombotic events, such as deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, etc within the year prior to screening.
- Subject has had an immune globulin associated arterial or venous thrombotic/thromboembolic event (TEE) within 7 days of infusion or a TEE that is not associated with an immune globulin within one year of screening.
- Subject has received blood products (except for IGIV, SCIG, or albumin) within 6 months of screening.
- Subject has anemia (≤8.5 g/dL).
- Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3.0 times the upper limit of normal (ULN).
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- Subject has severe neutropenia (≤1000 neutrophils per mm3).
- Subject is receiving other immunosuppressive or immunomodulatory drugs or chemotherapy.
- Subject is taking or has taken within the four weeks prior to screening prednisone at ≥0.15 mg/kg/day for more than 10 days.
- Subject has ever had a severe anaphylactic reaction to a blood or IgG product.
- Subject has lymphoid malignancy, leukemia, or any other history of malignancy within the past five years, except squamous cell or basal cell carcinoma of the skin (not melanoma).
- Subject has hypoalbuminemia, protein-losing enteropathy, or proteinuria greater than 300 mg/24 hours except for subjects with documented orthostatic proteinuria.
- Subject has immunoglobulin A (IgA) deficiency with known antibodies to IgA.
- Female who is pregnant, breastfeeding, or planning a pregnancy during the course of the study (women who become pregnant during the study will be withdrawn from the study).
- Any condition that is likely to interfere with evaluation of IMP or satisfactory conduct of the trial in the PI's opinion.
- Subjects who may not be compliant or have a history of non-compliance in the opinion of the PI.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
IMMUNOe Health & Research Centers
Centennial, Colorado, 80112
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, 20815
Optimed Research LTD
Columbus, Ohio, 43235
Allergy Partners of North Texas
Dallas, Texas, 75230
AARA Research Center
Dallas, Texas, 75231
AAICPA
Irving, Texas, 75063
Optimed Research Ltd.
Little Silver, New Jersey, 07739
University of California
Los Angeles, California, 92697
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
University of South Florida
Tampa, Florida, 33620
Allergy Associates of the Palm Beaches, P.A.
West Palm Beach, Florida, 33408
About this study
Official title: A Prospective, Open-Label, Multicenter Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Therapure PlasmaCap IG in Adults and Children With Primary Immune Deficiency Diseases
The purpose of this study is to investigate the efficacy, safety, tolerability, and pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on the basis of historical control data, how it compares with other 10% intravenous immunoglobulin (IGIV) products currently licensed in North America for the treatment of subjects with primary immune deficiency diseases (PIDD).
- Being tested
- 10% IGIV
- 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.
10% IGIVBiological
Also called Human Immunoglobulin
300-900 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Open-Label 10% IGIV | Experimental | IMP will be administered every 21 or 28 days in accordance with the subject's weekly regimen at screening for a period of 12 months. Subjects on a 21-day regimen will receive approximately 17 infusions, and subjects on a 28-day regimen will receive approximately 13 infusions.
The starting dose will be the previous IGIV dose or a dose calculated from the previous SCIG dose up to a maximum of 900 mg/kg/mo. Receives: Biological: 10% IGIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Acute Serious Bacterial Infection (SBI) Rate
The primary efficacy endpoint was the rate of acute SBI (pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, visceral abscess) per participant during the 12-month study observation period
Measured: 1 year
Secondary outcomes (3)
Immunoglobulin G (IgG) Trough Concentration
The average serum total IgG trough concentration
Measured: Up to 1 year per participant
Days Unable to Perform Daily Activities
The number of days out of work/school/daycare or unable to perform normal daily activities due to infections
Measured: Up to 1 year per participant
Therapeutic IgG Levels
Number of participants with maintenance of stable IgG levels
Measured: Up to 1 year per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start5 Sep 2017
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Immune Deficiency Diseases (PIDD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolve Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Krause, Study director, Therapure Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238079
- Sponsor's protocol ID
- TBI-001-IGIV
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2017
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Multicenter Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Therapure PlasmaCap IG in Adults and Children With Primary Immune Deficiency Diseases
- ClinicalTrials.gov ID
- NCT03238079
- Acronym / sponsor ID
- TBI-001-IGIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Evolve BiologicsIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy, safety, tolerability, and pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on the basis of historical control data, how it compares with other 10% intravenous immunoglobulin (IGIV) products currently licensed in North America for the treatment of subjects with primary immune deficiency diseases (PIDD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label 10% IGIV | Experimental | Biological: 10% IGIVIMP will be administered every 21 or 28 days in accordance with the subject's weekly regimen at screening for a period of 12 months. Subjects on a 21-day regimen will receive approximately 17 infusions, and subjects on a 28-day regimen will receive approximately 13 infusions. The starting dose will be the previous IGIV dose or a dose calculated from the previous SCIG dose up to a maximum of 900 mg/kg/mo. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has a confirmed clinical diagnosis of a PIDD, which requires treatment with IGIV:
- Subject/guardian has provided written informed consent (and assent, as applicable).
- Subject is between the ages of 2 and 70 years.
- Subject has received regular IGIV therapy at 21- or 28-day (±4 days) intervals for at least three consecutive months at a dose between 300-900 mg/kg/month prior to Screening or;
- Subject has received commercial SCIG at a dose of 300-900 mg/kg/month on any dosing schedule for at least 12 consecutive weeks prior to Screening. Subjects on SCIG must have received and tolerated IGIV treatment prior to SCIG treatment.
Key exclusion criteria (16 listed)
- Subject has secondary immunodeficiency.
- Subject has history of thrombotic events, such as deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, etc within the year prior to screening.
- Subject has had an immune globulin associated arterial or venous thrombotic/thromboembolic event (TEE) within 7 days of infusion or a TEE that is not associated with an immune globulin within one year of screening.
- Subject has received blood products (except for IGIV, SCIG, or albumin) within 6 months of screening.
- Subject has anemia (≤8.5 g/dL).
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 |
|---|---|---|
| 10% IGIVAlso: Human Immunoglobulin300-900 mg/kg | Biological | Open-Label 10% IGIV |
Primary outcome
Mean Acute Serious Bacterial Infection (SBI) Rate
Time frame: 1 year
The primary efficacy endpoint was the rate of acute SBI (pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, visceral abscess) per participant during the 12-month study observation period
3 secondary outcomes
Immunoglobulin G (IgG) Trough Concentration
Time frame: Up to 1 year per participant
Days Unable to Perform Daily Activities
Time frame: Up to 1 year per participant
Therapeutic IgG Levels
Time frame: Up to 1 year per participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Mark Krause study director
Therapure Biopharma
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10% IGIV in people with Primary Immune Deficiency Diseases (PIDD), run by Evolve Biologics at 12 sites in 2 countries.
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 16 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: finished, as of the sponsor's last update on 30 Jun 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 United States, Canada. 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?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Acute Serious Bacterial Infection (SBI) Rate (time frame: 1 year). 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 30 Jun 2026.