Status and phase
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Treatments
About
The purpose of this study is to evaluate the effects of siltuximab on immune cell functions in patients with Type 1 diabetes (T1D).
Full description
This is an open-label (all people know the identity of the intervention), single center, non-randomized (patients are not assigned by chance to treatment groups), Mechanistic Study (a study that focuses on the biologic activity of the drug, rather than on disease treatment). Up to 10 patients with Type 1 diabetes (T1D) will be enrolled in the study. Participants will receive a single dose of siltuximab and blood samples will be obtained a total of 6 times until 12 weeks after dosing. Cells will be isolated from the blood samples and used to measure specific activities of cells in the immune system. Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. The end of study is the date of the last assessment for the last patient.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies;
History of malignancy or serious uncontrolled cardiovascular disease or hypertension, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia despite therapy;
Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections;
History or serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C;
Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection;
Active infection with EBV ;
Active infection with CMV;
Diagnosis of liver disease or elevated hepatic enzymes, confirmed by repeat tests, as defined by ALT, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > ULN;
Any of the following hematologic abnormalities, confirmed by repeat tests:
Females who are pregnant or lactating;
Receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guérin, and small pox) in the 6 weeks before treatment;
Receipt of non-live vaccine in the 4 weeks before treatment;
Any medical or psychological condition that in the opinion of the Sponsor Investigator would interfere with the safe completion of the trial;
Receipt of an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months or 5 half-lives before enrollment or is currently enrolled in the treatment stage of an investigational study;
Receipt of any immune-modulating biologic drug within 3 months of enrolling in the study.
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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