Status:
TERMINATED
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Autoimmunity Centers of Excellence
Bristol-Myers Squibb
Conditions:
IgG4 Related Disease
IgG4-RD
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a two-part multi-center clinical trial in participants with active IgG4-RD. Part 1 (Cohort 1a and Cohort 1B) is an open-label, dose escalation phase to determine the safety of elotuzumab for ...
Detailed Description
Immunoglobulin G4-Related Disease (IgG4-RD) is a chronic fibro-inflammatory condition that can affect virtually every organ system, including the pancreas, biliary tract, salivary and lacrimal glands,...
Eligibility Criteria
Inclusion
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- Participant must be able to understand and provide informed consent and be willing to comply with study procedures and follow up.
- Are at least 18 years of age and not older than 70 years of age at screening.
- Meet the ACR/EULAR Classification Criteria for IgG4-RD \[30, 31\].
- Have active disease based at screening on an IgG4-RD RI ≥4, with disease manifestations in at least two organ systems.
- May have newly-diagnosed or relapsing disease at screening. Relapsing disease is defined as IgG4-RD that has previously been in remission but is now active again.
- May be on treatment or off treatment for IgG4-RD at the time of screening. If on treatment, must be willing to discontinue those other treatments before the baseline visit.
- No history of severe allergic reactions to monoclonal antibodies.
- Female participants of childbearing potential must have a negative pregnancy test upon study entry.
- Female participants of childbearing potential and male participants with a partner of childbearing potential must agree to consistently and correctly use FDA approved highly effective methods of birth control for the entire duration of the study and 6 months after last elotuzumab infusion.
- Immunization with one of the FDA authorized or licensed SARS-CoV-2 vaccines as per CDC recommendations at the time of informed consent is required for study entry. Vaccinations must have been completed at least 2 weeks prior to start of study therapy.
Exclusion
- Individuals who meet any of these criteria are not eligible for enrollment as study participants:
- Presence of a condition other than IgG4-RD that (e.g., asthma) is likely to require systemic Glucocorticoids (GC) for disease control during the period of the trial.
- Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin.)
- The following lab values as indicators of hepatic dysfunction:
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times the upper limit of normal (ULN)
- Total bilirubin \> two times the ULN unless caused by Gilbert's disease. Gilbert's disease with total bilirubin \> three times ULN.
- Serum albumin \< 2.5 gm/dL.
- Evidence of another uncontrolled condition which, in the judgment of the investigator, could interfere with participation in the trial according to the protocol.
- Active infection requiring hospitalization or treatment with systemic antimicrobial agents within the 30 days prior to treatment allocation/randomization.
- Prior use of rituximab or other B cell depleting agents within 9 months of enrollment unless B cells have been demonstrated to have repopulated.
- Use of any investigational agent or biologic and non-biologic DMARDs within 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment.
- Any of the following laboratory tests at the Screening Visit:
- White blood cell count (WBC) \< 3.0 x 103/µL.
- Absolute neutrophil count (ANC) \< 1.5 x 103/µL.
- Hemoglobin \< 10 g/dL.
- Platelet count \< 75 x 109/L.
- Estimated glomerular filtration rate (eGFR) ≤ 45 ml/minute/1.73 m2.
- The use of supplemental oxygen at baseline.
- At or within 90 days of screening: Positive Interferon-Gamma Release Assay (IGRA). Indeterminate IGRAs must be repeated (with same or other IGRA per local policy) and shown to be negative. Alternatively, if the assay remains indeterminant, a participant must have a negative PPD. Finally, if the participant has had the Bacille Calmette-Guerin (BCG) vaccine or has some other condition complicating the interpretation of TB testing, consultation with infectious disease specialist must be obtained before receipt of the first investigational infusion.
- a. Participants diagnosed with latent TB are eligible but must have received appropriate prophylaxis for 30 days before their first investigational infusion.
- Medical history or serologic evidence at Screening of chronic infections including:
- Human immunodeficiency virus infection.
- Hepatitis B as indicated by surface antigen or hepatitis B core antibody positivity
- Hepatitis C as indicated by anti-hepatitis C antibody positivity; if a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if he/she is negative for viral load at Screening.
- Live vaccines within 8 weeks of initiating study therapy.
- Participant is pregnant or breastfeeding, or planning a pregnancy while enrolled in the study.
- Substance use disorder, including the recurrent use of alcohol and/or drugs within the past year associated with clinically significant impairment associated with failure to meet major responsibilities at work, school, or home.
- IgG4-RD that is dominated primarily by advanced fibrotic lesions. Specifically, participants whose disease manifestations consist only of
- retroperitoneal fibrosis,
- fibrosing mediatinitis,
- sclerosing mesenteritis, or
- Riedel's thyroiditis. Participants with these disease manifestations can be included, however, only if they have disease in 2 organ systems that is not of an advanced fibrotic nature and otherwise meet the Inclusion and Exclusion Criteria.
- Evidence a SARS-CoV-2 (COVID-19) infection started within the 30 days prior to treatment allocation/randomization. Participants diagnosed with SARS-CoV-2 (COVID-19) infection more than 30 days prior to treatment allocation/randomization must have symptoms resolved and be deemed fit to participate in the trial.
Key Trial Info
Start Date :
October 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04918147
Start Date
October 13 2021
End Date
January 4 2024
Last Update
July 30 2025
Active Locations (3)
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1
Emory Healthcare
Atlanta, Georgia, United States, 30322
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Mayo Clinic: Pulmonary and Critical Care Medicine
Rochester, Minnesota, United States, 55905