Testing Teplizumab against a placebo for type 1 diabetes mellitus

Exclusion

• −At screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
• −Participants are excluded from the study if any of the following criteria apply:
• −Participant has an active serious infection and/or fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.
• −At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).
• −Participant has evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
• −Has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease (at discretion of InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →).
• −Any clinically significant abnormality identified either in medical/surgical history or during screening evaluation (eg, physical examination, laboratory tests, vital signs), or any adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AE) during screening period which, in the judgment of the investigator, would preclude safe completion of the study or constrains efficacy assessment.
• −Participant has recent or planned vaccinations as follows:
• −Live-attenuated (live) vaccines (eg, varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) within the 8 weeks before first dose of the investigational medicinal product (IMP) or planned/required administration during treatment or up to 26 weeks after last IMP administration in any treatment course
• −Inactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.
• −Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin
• −Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including but not limited to systemic corticosteroids (ie, oral, high doses of inhaled or injectable) with duration \>14 days, adrenocorticotropic hormone, verapamil).
• −Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.
• −Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).
• −Participant has previously received teplizumab or other anti-CD3 treatment.
• −Other medications not compatible or interfering with IMP at discretion of Investigator.
• −Current enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 8 weeks or 5 half-lifes, whichever is longer, prior to screening.
• −Participant has any of the following laboratory parameters, at screening prior to first dose:
• −Lymphocyte count: \<1000/µL,
• −Neutrophil count: \<1500/µL (\< 1000 /µL in participants with documented Duffy-null genotype),
• −Platelet count: \<150,000 platelets/µL,
• −Hemoglobin: \<10 g/dL,
• −Aspartate aminotransferase (AST) \>2.0 × upper limit of normal (ULN),
• −Alanine aminotransferase (ALT) \>2.0 × ULN,
• −Total bilirubin \>1.5 × ULN with the exception of participants with the diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to hyperbilirubinemia
• −The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
• −Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.