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Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants with Immunoglobulin G4-related Disease (IgG4-RD)
EU CTIS ID: 2025-520988-41-00
What this study is testing
To characterize the pharmacokinetics (PK) of inebilizumab administered in pediatric participants with Immunoglobulin G4-related Disease (IgG4-RD) To characterize the pharmacodynamics (PD) of inebilizumab administered in pediatric participants with IgG4 RD To assess the safety and tolerability of inebilizumab administered in pediatric participants with IgG4-RD
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 101 Participants must weigh ≥ 17 kg to be eligible for enrollment.
- 102 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.
- 103 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.
- 104 Clinical diagnosis of IgG4-RD.
- 105 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.
- 106 Receipt of all age-appropriate and locally-required vaccinations before screening.
You likely can't join if
- 201 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 glucocorticoid treatment.
- 218 Receipt of any of the following before day 1: alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy.
- 202 Malignancy (except any of the following nonmelanoma skin cancers, or cervical or breast ductal carcinoma in situ) within the last 5 years.
- 219 Receipt of any of the following within 2 months before day 1: azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cyclophosphamide, tocilizumab, satralizumab, eculizumab, and mitoxantrone.
- 220 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.
- 221 Receipt of intravenous immunoglobulin (IVIG) within 1 month before day 1.
See the full eligibility criteria
Who can join
- 101 Participants must weigh ≥ 17 kg to be eligible for enrollment.
- 102 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.
- 103 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.
- 104 Clinical diagnosis of IgG4-RD.
- 105 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.
- 106 Receipt of all age-appropriate and locally-required vaccinations before screening.
- 107 Participants requiring treatment in addition to or other than GCs for IgG4 RD according to PI’s assessment at screening.
- 108 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.
What rules you out
- 201 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 glucocorticoid treatment.
- 218 Receipt of any of the following before day 1: alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy.
- 202 Malignancy (except any of the following nonmelanoma skin cancers, or cervical or breast ductal carcinoma in situ) within the last 5 years.
- 219 Receipt of any of the following within 2 months before day 1: azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cyclophosphamide, tocilizumab, satralizumab, eculizumab, and mitoxantrone.
- 220 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.
- 221 Receipt of intravenous immunoglobulin (IVIG) within 1 month before day 1.
- 222 Receipt of natalizumab within 6 months before day 1.
- 223 Severe drug allergic history or anaphylaxis to 2 or more food products or medicines (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid).
- 224 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.
- 225 Currently receiving treatment in another investigational device or drug study, or less than 5 half-lives since ending treatment in another investigational device or drug study. This does not apply to other investigational procedures or participation in observational research studies.
- 226 Participants of childbearing potential unwilling to use protocol-specified method of contraception (see Section 11.5 [Appendix 5]) during treatment and for an additional 6 months after the last dose of inebilizumab.
- 210 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.
- 227 Participants who are breastfeeding or who plan to breastfeed while on study through 6 months after the last dose of investigational product.
- 228 Participants planning to become pregnant while on study through 6 months after the last dose of investigational product.
- 203 Major surgery within 8 weeks before screening.
- 229 Participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
- 230 Participants with a partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of investigational product. Refer to Section 11.5 (Appendix 5) for additional contraceptive information.
- 231 Participants assigned male at birth with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 6 months after the last dose of investigational product.
- 232 Participants unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of investigational product.
- 233 Participant has known sensitivity to any of the products to be administered during dosing.
- 234 Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant’s and investigator’s knowledge.
- 235 History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant’s safety, or interfere with the study evaluation, procedures, or completion.
- 211 Positive test for chronic hepatitis B infection at screening, defined as either: (1) positive hepatitis B surface antigen (HBsAg); or (2) a 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.
- 204 Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before screening.
- 205 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) • 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)
- 206 Estimated glomerular filtration rate < 45 mL/min/1.73 m2.
- 207 B-cell counts < one-half of the lower limit of normal (LLN) for age according to the central laboratory.
- 208 Diagnosed with a concurrent autoimmune disease that is uncontrolled or requires any prohibited medication (unless approved by the medical monitor).
- 209 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.
- 212 History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV) unless the participant is considered to be cured following antiviral therapy and has an HCV viral load below the limit of detection at least 24 weeks after completion of treatment at site or central lab.
- 213 History of active or latent tuberculosis (TB), or a positive QuantiFERON-TB Gold test at screening, unless treatment for TB was completed per local guidelines.
- 214 Negative test for varicella zoster virus (VZV)-IgG.
- 215 Participants with any of the following abnormal liver function tests in the absence of hepatobiliary IgG4-RD activity: • AST > 2 × ULN • ALT > 2 × ULN • TBL > 2 × ULN unless AST, ALT, and hemoglobin are within central laboratory normal range and the participant has a known history of Gilbert syndrome
- 216 History of alcohol or drug abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits or interfere with safety or other study assessments
- 217 Known positive anti-neutrophil cytoplasmic antibodies targeted against proteinase 3 or myeloperoxidase if done based on participant records.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- China
- Brazil
- United States
- United Kingdom
- Japan
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; China; Brazil; United States; United Kingdom; Japan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.