HypogammaglobulinemiaPhase 3NCT07220915

Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections

A Phase 3 study testing Panzyga, 10% Intravenous Solution in people with Hypogammaglobulinemia and Autoimmune Conditions, run by Octapharma at 17 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypogammaglobulinemia, Autoimmune Conditions, Rheumatic Conditions
What is being tested?: Panzyga, 10% Intravenous Solution
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 17 sitesin 6 countries
Study dates: 10 Jun 2026to Dec 2029
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who meet all of the following criteria will be eligible to participate in the study:
Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.
Have hypogammaglobulinemia (IgG levels <5 g/L as confirmed by the central laboratory).
Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..
Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Who cannot join

Patients who meet any of the following criteria will be excluded from participation in the study:
Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component
Have a current major infection at Screening or had >1 major infection within 6 months prior to Baseline
Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline
Have a known IgA deficiency with antibodies to IgA
Have a known blood hyperviscosity or other hypercoagulable states

Show all 18Show fewer

Have been diagnosed with primary immunodeficiency.
Have a severe liver disease, with signs of ascites or hepatic encephalopathy
Have a severe kidney disease (as defined by eGFR <30 mL/min/1.73 m2)
Have a body weight >140 kg
HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV- 1/2 antigen/antibody immunoassay followed by positive HIV-1/HIV-2 antibody differentiation immunoassay)
Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.
Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).
Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study
Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration
Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product within 3 months prior to Baseline or during the course of this study. Participation in observational or open-label studies involving an approved product may be permitted after consultation with the Medical Monitor.
If female, are pregnant or lactating
Are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator

Trial locations and contacts

17 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Theresa Conklin contact

413-821-0022

t.conklin@crmg-usa.com

Country

City, postcode or hospital

Sites recruiting now only

17 sites in 6 countries

United States6 sites, 2 recruiting

AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Fort Worth
Fort Worth, Texas, 76109
Active, not recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix
Glendale, Arizona, 85306
Active, not recruiting
AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving 6750 N. MacArthur Blvd, Suite 304
Irving, Texas, 75039
Active, not recruiting
AARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Mesa
Mesa, Arizona, 85210
Recruiting
Perseverance Research Center, Phoenix Neurological Associates
Scottsdale, Arizona, 85253
Recruiting
AARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Tucson
Tucson, Arizona, 85704
Active, not recruiting

Other trials in United States

Lithuania4 sites

Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
Kaunas, 50161
Active, not recruiting
Vilnius University Hospital Santaros Klinikos, Santariskiu str 2, Vilnius University Hospital Santaros Klinikos A housing, 11th floor
Vilnius, 08406
Active, not recruiting
Vilnius University Hospital Santaros Klinikos, Santariskiu g. 2
Vilnius, 08661
Active, not recruiting
Vilnius University Hospital Santaros Klinikos, Santariskiu str. 2,
Vilnius, 08661
Active, not recruiting

Other trials in Lithuania

Bulgaria2 sites, 1 recruiting

Medical Center Artmed
Plovdiv, 4002
Recruiting
UMHAT Sveti Georgi EAD
Plovdiv, 4002
Active, not recruiting

Other trials in Bulgaria

Latvia2 sites

P. Stradins Clinical University Hospital
Riga, 1002
Active, not recruiting
Riga East Clinical University Hospital
Riga, 1079
Active, not recruiting

Other trials in Latvia

Poland2 sites, 2 recruiting

Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, 80803
Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637
Recruiting

Other trials in Poland

Greece1 site

University General Hospital of Keraklion
Heraklion, 71110
Active, not recruiting

Other trials in Greece

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients With Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment With B-cell Depletion Therapy ("PROTECT")

Conditions: Hypogammaglobulinemia, Autoimmune Conditions, Rheumatic Conditions, Infections
Being tested: Panzyga, 10% Intravenous Solution, Placebo
Medical subject headings: Agammaglobulinemia, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Panzyga, 10% Intravenous SolutionDrug
Panzyga is a 10% Ig formulation for intravenous (IV) administration
PlaceboOther
4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion

Study groups in NCT07220915
Study group	Role	What they receive
Panzyga 10%	Active comparator	Panzyga is a 10% Ig formulation for intravenous (IV) administration. The product is delivered as a ready-to-use solution in glass bottles. Patients in the Panzyga treatment arm will receive 0.4 g/kg (4 mL/kg) per single infusion every 4 weeks for up to 48 weeks (up to 13 infusions). In the open-label phase patients will receive Panzyga 0.4 g/kg. If 3-4 weeks after the first open-label infusion the IgG trough level falls below 7 g/L, the dose will be increased to 0.6 g/kg. Additionally, the dose may be increased to 0.6 g/kg if a patient experiences one more major infection, or ≥2 other (non-major) infections. Receives: Drug: Panzyga, 10% Intravenous Solution
Placebo	Placebo comparator	4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion every 4 weeks for up to 48 weeks (up to 13 infusions). Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of Major Infections in Participants
Occurrence of at least one major infection or death in patients with or without primary infection prophylaxis with Panzyga during the treatment period. Each potential infection will be assessed by an Independent Adjudication Committee (IAC). Major infections will be defined as bacterial and/or viral infections, which are microbiologically documented or clinically documented requiring treatment with anti-infective, including those resulting in death, excluding confirmed cases of COVID-19.
Measured: 48 weeks

Secondary outcomes (3)

Time to Major Infections in Participants
Time to first major infection (as assessed by the IAC) during the treatment period or death. The secondary safety endpoints of this study include the incidence of adverse events and changes from baseline in physical examinations and clinical laboratory parameters.
Measured: 48 weeks
Number of Participants Experiencing AEs
Incidents of AEs during the treatment period
Measured: 48 weeks
Participants Experiencing Changes from Baseline in Physical Examinations, and Clinical Laboratory Parameters
Changes from baseline in physical examination findings and clinical laboratory parameters will be assessed during the treatment period. Each parameter will be reported separately according to its unit of measure, such as body weight (kg), height (cm), body mass index (kg/m²), and individual laboratory values (e.g., hemoglobin [g/dL], serum creatinine [mg/dL]). Where applicable, related measurements (e.g., weight and height) will be combined to derive a single parameter, such as body mass index, to ensure consistent and interpretable results.
Measured: 48 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 2026Dec 2029

First posted24 Oct 2025
Study start10 Jun 2026
Primary completionDec 2029 (estimated)
Study completionDec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypogammaglobulinemiaStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07220915
Sponsor's protocol ID: NGAM-16
Status last verified: Aug 2026
First submitted: 30 Sep 2025
Last updated: 29 Sep 2026
Results posted: No
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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients With Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment With B-cell Depletion Therapy ("PROTECT")
ClinicalTrials.gov ID: NCT07220915
Acronym / sponsor ID: NGAM-16
Conditions: Hypogammaglobulinemia, Autoimmune Conditions, Rheumatic Conditions, Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 360 participants (estimated)
Lead sponsor: OctapharmaIndustry (pharma, biotech, devices)
Study start: 10 Jun 2026 (actual)
Primary completion: Dec 2029 (estimated)
Study completion: Dec 2029 (estimated)
First posted: 24 Oct 2025 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Panzyga 10%	Active comparator	Drug: Panzyga, 10% Intravenous SolutionPanzyga is a 10% Ig formulation for intravenous (IV) administration. The product is delivered as a ready-to-use solution in glass bottles. Patients in the Panzyga treatment arm will receive 0.4 g/kg (4 mL/kg) per single infusion every 4 weeks for up to 48 weeks (up to 13 infusions). In the open-label phase patients will receive Panzyga 0.4 g/kg. If 3-4 weeks after the first open-label infusion the IgG trough level falls below 7 g/L, the dose will be increased to 0.6 g/kg. Additionally, the dose may be increased to 0.6 g/kg if a patient experiences one more major infection, or ≥2 other (non-major) infections.
Placebo	Placebo comparator	Other: Placebo4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion every 4 weeks for up to 48 weeks (up to 13 infusions).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients who meet all of the following criteria will be eligible to participate in the study:
Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.
Have hypogammaglobulinemia (IgG levels <5 g/L as confirmed by the central laboratory).
Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..
Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Key exclusion criteria (18 listed)

Patients who meet any of the following criteria will be excluded from participation in the study:
Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component
Have a current major infection at Screening or had >1 major infection within 6 months prior to Baseline
Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline
Have a known IgA deficiency with antibodies to IgA

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
Panzyga, 10% Intravenous SolutionPanzyga is a 10% Ig formulation for intravenous (IV) administration	Drug	Panzyga 10%
Placebo4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion	Other	Placebo

Primary outcome

Occurrence of Major Infections in Participants
Time frame: 48 weeks
Occurrence of at least one major infection or death in patients with or without primary infection prophylaxis with Panzyga during the treatment period. Each potential infection will be assessed by an Independent Adjudication Committee (IAC). Major infections will be defined as bacterial and/or viral infections, which are microbiologically documented or clinically documented requiring treatment with anti-infective, including those resulting in death, excluding confirmed cases of COVID-19.

3 secondary outcomes

Time to Major Infections in Participants
Time frame: 48 weeks
Number of Participants Experiencing AEs
Time frame: 48 weeks
Participants Experiencing Changes from Baseline in Physical Examinations, and Clinical Laboratory Parameters
Time frame: 48 Weeks

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 29 Sep 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.

Theresa Conklin contact

413-821-0022

t.conklin@crmg-usa.com

17 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Panzyga, 10% Intravenous Solution in people with Hypogammaglobulinemia and Autoimmune Conditions, run by Octapharma at 17 sites in 6 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 5 inclusion and 18 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Lithuania, Bulgaria, Latvia, Poland and 1 more country. 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. Some participants in this study may receive a placebo. 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?

Contact Theresa Conklin (413-821-0022, t.conklin@crmg-usa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Major Infections in Participants (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07220915.

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 29 Sep 2026.