Immunoglobulin G4-related DiseasePhase 2NCT07222553
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
A Phase 2 study testing Inebilizumab in people with Immunoglobulin G4-related Disease, run by Amgen at 14 sites in 7 countries.
Trial summary
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Immunoglobulin G4-related Disease
- What is being tested?
- Inebilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 31 Oct 2026to 10 Jun 2031
- Phase
- Phase 2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must weigh ≥ 17 kg to be eligible for enrollment.
- Participant has provided informed consent/assent before initiation of any study-specific activities/procedures. Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.
- Age 2 to < 18 years at the time of screening. For participants who reach the age of legal consent during the clinical study, notification will be required, and a new consent form must be signed by the participant for continuation in the study.
- Clinical diagnosis of IgG4-RD.
- Fulfillment of the 2019 American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) classification criteria as determined by the principal investigator (PI) at screening. Specifically, participants must meet the classification criteria entry requirements (including involvement of one of the following organs: pancreas, bile ducts/biliary tree, orbits, lungs, kidneys, lacrimal glands, major salivary glands, retroperitoneum, aorta, pachymeninges, or thyroid gland [Riedel's thyroiditis]), must not meet any of the classification criteria exclusions, and must achieve at least 20 classification criteria inclusion points.
- Receipt of all age-appropriate and locally-required vaccinations before screening.
- Participants requiring treatment in addition to or other than glucocorticoids (GCs) for IgG4-RD according to PI's assessment at screening.
- Participants who are on GCs for the treatment of IgG4-RD should remain on a stable dose for at least 2 weeks before enrollment (Day 1). Tapering post enrollment will be at PI's discretion.
Who cannot join
- Participants with any of the following abnormal liver function tests in the presence of hepatobiliary IgG4-RD activity:
- aspartate aminotransferase (AST) > 10 × upper limit of normal (ULN)
- alanine aminotransferase (ALT) > 10 × ULN
- total bilirubin (TBL) > 5 × ULN Screening liver function tests may be repeated before Day 1 to permit abnormal values due to hepatobiliary IgG4-RD activity to respond to GC treatment.
- Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality, including any of the following at screening (one repeat test may be conducted to confirm results within the same screening period):
- platelet count < 75000/μL (or < 75 × 109/L)
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- absolute neutrophil count < 1200 cells/μL
- total Ig < 600 mg/dL
- CD4 T lymphocyte count < 300 cells/µL
- hemoglobin < 8 g/dL (or < 80 g/L).
- Estimated glomerular filtration rate < 45 mL/min/1.73 m^2.
- B-cell counts < one-half of the lower limit of normal (LLN) for age according to the central laboratory.
- Diagnosed with a concurrent autoimmune disease that is uncontrolled or requires any prohibited medication (unless approved by the medical monitor).
- Clinically significant serious active or chronic viral, bacterial, or fungal infection that requires treatment with anti-infectives, hospitalization, or, in the investigator's opinion, represents an additional risk to the participant, within 2 months before Day 1 of study.
- Known history of congenital or acquired immunodeficiency (eg, due to human immunodeficiency virus [HIV] infection, splenectomy, immunosuppression-related or idiopathic T-cell deficiencies) that predisposes the participant to infection.
- Positive test for chronic hepatitis B infection at screening, defined as either: (1) Positive hepatitis B surface antigen (HBsAg); or (2) Positive hepatitis B core antibody (anti-HBc) PLUS negative hepatitis B surface antibody (anti-HBs). Note: Participants with a positive anti-HBs only, or a positive anti-HBc plus positive anti-HBs and negative HBsAg, are eligible to enroll.
- Receipt of any of the following before Day 1: alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy.
- Receipt of any of the following within 2 months before Day 1: azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cyclophosphamide, tocilizumab, satralizumab, eculizumab, and mitoxantrone.
- Receipt of rituximab or any experimental B-cell depleting agent (eg, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab), or any non-depleting B-cell-directed therapy (eg, belimumab), abatacept, within 6 months before screening unless B-cell counts have returned to ≥ one-half the LLN.
- Receipt of any live or attenuated vaccine (administration of inactivated [killed] vaccine is acceptable) within 4 weeks before Day 1, Bacillus Calmette-Guérin vaccine within 1 year of screening, or blood transfusion within 4 weeks before screening or during screening.
Trial locations and contacts
14 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 7 countries
United States3 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, 33612
Turkey (Türkiye)3 sites
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, 34764
China2 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Greece2 sites
Euroclinic Children Hospital
Athens, 11521
General Children Hospital Panagioti and Aglaias Kyriakou
Athens, 11527
Poland2 sites
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, 02-637
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, 04-730
About this study
Official title: Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Immunoglobulin G4-related Disease (IgG4-RD)
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD.
- Conditions
- Immunoglobulin G4-related Disease
- Being tested
- Inebilizumab
- Keywords
- Immunoglobulin G4-related Disease, Inebilizumab, AMG 335, IgG4-related disease, IgG4-RD
- Medical subject headings
- Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InebilizumabDrug
Inebilizumab will be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Inebilizumab | Experimental | Participants will receive Inebilizumab via intravenous (IV) infusion. Receives: Drug: Inebilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Inebilizumab
Measured: Up to Day 561
Area Under the Plasma Concentration-time Curve (AUC) of Inebilizumab
Measured: Up to Day 561
Clearance (CL) of Inebilizumab
Measured: Up to Day 561
Terminal Half-life (t½) of Inebilizumab
Measured: Up to Day 561
Volume of Distribution at Steady-state (Vss) of Inebilizumab
Measured: Up to Day 561
Change from Baseline in CD20+ B-cell Counts
Measured: Baseline and Day 561
Number of Participants Experiencing Adverse Events (AEs)
Measured: Up to Day 561
Number of Participants Experiencing Serious Adverse Events (SAEs)
Measured: Baseline up to Day 561
Number of Participants Experiencing Events of Interest (EOIs)
Measured: Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Laboratory Parameters
Measured: Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Vital Signs
Measured: Baseline up to Day 561
Secondary outcomes (5)
Time-to-first Treated Flare Across 52 Weeks
Measured: Up to Week 52
Percentage of Flare-free Participants Across 52 Weeks
Measured: Up to Week 52
Annualized Flare Rate Across 52 Weeks
Measured: Up to Week 52
Presence of Antidrug Antibodies (ADA) Before and After Initiation of Treatment
Measured: Day 1 to Day 561
Percent Reduction from Baseline in Daily Glucocorticoid Dose at Week 52
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start31 Oct 2026 (estimated)
- Primary completion10 Jun 2031 (estimated)
- Study completion10 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin G4-related DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222553
- Sponsor's protocol ID
- 20240202
- Other IDs
- 2025-520988-41-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Immunoglobulin G4-related Disease (IgG4-RD)
- ClinicalTrials.gov ID
- NCT07222553
- Acronym / sponsor ID
- 20240202
- Conditions
- Immunoglobulin G4-related Disease
- Keywords
- Immunoglobulin G4-related Disease, Inebilizumab, AMG 335, IgG4-related disease, IgG4-RD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 10 Jun 2031 (estimated)
- Study completion
- 10 Jun 2031 (estimated)
- First posted
- 30 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.
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inebilizumab | Experimental | Drug: InebilizumabParticipants will receive Inebilizumab via intravenous (IV) infusion. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Participants must weigh ≥ 17 kg to be eligible for enrollment.
- Participant has provided informed consent/assent before initiation of any study-specific activities/procedures. Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and/or guidelines before any study-specific activities/procedures being initiated.
- Age 2 to < 18 years at the time of screening. For participants who reach the age of legal consent during the clinical study, notification will be required, and a new consent form must be signed by the participant for continuation in the study.
- Clinical diagnosis of IgG4-RD.
- Fulfillment of the 2019 American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) classification criteria as determined by the principal investigator (PI) at screening. Specifically, participants must meet the classification criteria entry requirements (including involvement of one of the following organs: pancreas, bile ducts/biliary tree, orbits, lungs, kidneys, lacrimal glands, major salivary glands, retroperitoneum, aorta, pachymeninges, or thyroid gland [Riedel's thyroiditis]), must not meet any of the classification criteria exclusions, and must achieve at least 20 classification criteria inclusion points.
Key exclusion criteria (20 listed)
- Participants with any of the following abnormal liver function tests in the presence of hepatobiliary IgG4-RD activity:
- Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality, including any of the following at screening (one repeat test may be conducted to confirm results within the same screening period):
- Estimated glomerular filtration rate < 45 mL/min/1.73 m^2.
- B-cell counts < one-half of the lower limit of normal (LLN) for age according to the central laboratory.
- Diagnosed with a concurrent autoimmune disease that is uncontrolled or requires any prohibited medication (unless approved by the medical monitor).
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 |
|---|---|---|
| InebilizumabInebilizumab will be administered via IV infusion. | Drug | Inebilizumab |
Primary outcome
Maximum Plasma Concentration (Cmax) of Inebilizumab
Time frame: Up to Day 561
Area Under the Plasma Concentration-time Curve (AUC) of Inebilizumab
Time frame: Up to Day 561
Clearance (CL) of Inebilizumab
Time frame: Up to Day 561
Terminal Half-life (t½) of Inebilizumab
Time frame: Up to Day 561
Volume of Distribution at Steady-state (Vss) of Inebilizumab
Time frame: Up to Day 561
Change from Baseline in CD20+ B-cell Counts
Time frame: Baseline and Day 561
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to Day 561
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 561
Number of Participants Experiencing Events of Interest (EOIs)
Time frame: Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Laboratory Parameters
Time frame: Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Vital Signs
Time frame: Baseline up to Day 561
5 secondary outcomes
Time-to-first Treated Flare Across 52 Weeks
Time frame: Up to Week 52
Percentage of Flare-free Participants Across 52 Weeks
Time frame: Up to Week 52
Annualized Flare Rate Across 52 Weeks
Time frame: Up to Week 52
Presence of Antidrug Antibodies (ADA) Before and After Initiation of Treatment
Time frame: Day 1 to Day 561
Percent Reduction from Baseline in Daily Glucocorticoid Dose at Week 52
Time frame: Baseline and Week 52
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 27 Aug 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inebilizumab in people with Immunoglobulin G4-related Disease, run by Amgen at 14 sites in 7 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 20 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: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Turkey (Türkiye), China, Greece, Poland and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of Inebilizumab (time frame: Up to Day 561). The study lists 11 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 27 Aug 2026.