BridgeMD
Tests treatment safety and results for Type 1 Diabetes Mellitus
Official title Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
ClinicalTrials.gov ID: NCT06791291
What this study is testing
What is Teplizumab?
Teplizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for type 1 diabetes mellitus.
Also referred to as SAR446681, TZIELD.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment. Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 34
You may be able to join if
- Male or female Japanese participant, 1 (inclusive) to 34 years (inclusive) of age, at the time of signing the informed consent. Japanese: born in...
- Confirmed diagnosis of Stage 2 T1D based on following criteria:
- Participant is positive for 2 or more T1D related auto-antibodies (confirmed by written medical history and/or obtained at study screening). The...
- Oral glucose tolerance test (OGTT) or blood HbA1c confirms the participant has dysglycemia without overt hyperglycemia.
- Participant must be in good health (except for being Stage 2 T1D) as determined by medical e)valuation including medical history, physical...
See the full eligibility criteria
Who can join
- Male or female Japanese participant, 1 (inclusive) to 34 years (inclusive) of age, at the time of signing the informed consent. Japanese: born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4...
- Confirmed diagnosis of Stage 2 T1D based on following criteria:
- Participant is positive for 2 or more T1D related auto-antibodies (confirmed by written medical history and/or obtained at study screening). The autoantibodies that are to be confirmed are anti-GAD (glutamic acid...
- Oral glucose tolerance test (OGTT) or blood HbA1c confirms the participant has dysglycemia without overt hyperglycemia.
- Participant must be in good health (except for being Stage 2 T1D) as determined by medical e)valuation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) XE " ECG " \\f...
- Participant is up to date with routine age-appropriate immunizations according to current local specific guideline prior to randomization.
- Female participants should use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A female participant is considered fertile (woman of childbearing potential - WOCBP) from the time of menarche until becoming postmenopausal unless permanently sterile. Female participants are eligible to participate if...
- Is a woman of nonchildbearing potential (WONCBP) OR
- Is a WOCBP and agrees to keep abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or use other highly effective...
- Any presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic (except Stage 2 T1D), hematological, neurological, osteomuscular, articular, psychiatric...
- Participant has clinical signs and symptoms consistent with COVID19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4...
- For participant ≥18 years, blood donation of 400 mL within 12 weeks (male) or 16 weeks (female), 200 mL within 4 weeks or apheresis donation within 2 weeks before randomization; for participant \<18 years, blood...
- Presence or history of drug hypersensitivity to any biologic medication, or clinically significant allergic disease as diagnosed and treated by a physician. Participants with known hypersensitivity to teplizumab or...
- Participants with a history of active or latent or inactive tuberculosis (TB), including chest X-ray consistent with TB, regardless of treatment, or have a positive QuantiFERON-TB Gold test or T-SPOT TB test at...
- At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein Barr virus (EBV), or history of infectious mononucleosis within 3 months before enrollment.
- At screening, participant has laboratory or clinical evidence of acute or clinically active infection with cytomegalovirus (CMV).
- Participants with a history of invasive opportunistic infections, such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis, irrespective of resolution.
- Participants have other autoimmune diseases, except clinically stable autoimmune thyroid disease, or celiac disease.
- Participants with a history of malignancy occurring within 5 years before randomization (except successfully treated carcinoma in situ of the cervix, or adequately treated nonmetastatic squamous cell or basal cell...
- Participants with fever (temperature ≥38.0°C) within 48 hours before randomization; or with chronic persistent or recurring infection(s) requiring active treatment with antibiotics, antiviral or antifungals within 4...
- If female, pregnancy (defined as positive blood or urine pregnancy test) or breast-feeding.
- Participant has recent or planned vaccinations as follows:
- Live vaccines: within 8 weeks before randomization, and/or within 54 weeks after randomization.
- Non-live vaccines: any initial non-live vaccination within 2 weeks before randomization, and/or within 8 weeks after randomization.
- Participant has a current or prior (within 30 days before randomization) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including high dose, inhaled, extensive...
- Participant has a current or prior (within 30 days before randomization) treatment that is known to significantly influence glucose tolerance (anti-hyperglycemic agents, atypical antipsychotics, diphenylhydantoin...
- Participant has received any anti-CD3 (cluster of differentiation 3) antibody treatment (including teplizumab) before randomization.
- Participant who has received any biologic therapy within five half-lives of the therapy or within 6 months before randomization whichever is longer, or plan to receive any biologic therapy within 6 weeks after...
- Any participant enrolled or having participated, in this or any other clinical study involving an investigational medicinal product (IMP) or in any other type of medical research and is still in the exclusion period...
- Participant has any of the following hematologic parameters before randomization:
- Lymphocyte count \<1.0 ×109/L.
- Neutrophil count \<1.5 ×109/L.
- Platelet count \<150 ×109/L.
- Hemoglobin \<100 g/L.
- Participant has any of the following liver function test abnormalities before randomization:
- AST \>2 × ULN (upper limit normal).
- ALT \>2 × 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.
- Positive result on any of the following tests:
- Hepatitis B surface antigen or hepatitis B core antibody confirmed by positive HBV-DNA (hepatitis B virus DNA).
- Anti-hepatitis C virus antibody confirmed by positive HCV-RNA (hepatitis C virus RNA).
- Human immunodeficiency virus antigen/ antibodies.
- Positive SARS-CoV-2 test.
- Participant who has contraindications or known allergy to both nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, or anti-histamines and in the opinion of the Investigator, cannot participate in the study.
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. The...
The study team makes the final eligibility decision.
Where it's taking place
- Ichikawa, Chiba, Japan
- Sapporo, Hokkaido, Japan
- Kobe, Hyōgo, Japan
- Yahaba, Iwate, Japan
- Yokohama, Kanagawa, Japan
- Iruma, Saitama, Japan
- Chūō, Yamanashi, Japan
- Fukuoka, Japan
- Kyoto, Japan
- Osaka, Japan
- Tokyo, Japan
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, 1 year to 34 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ichikawa, Chiba, Japan; Sapporo, Hokkaido, Japan; Kobe, Hyōgo, Japan; Yahaba, Iwate, Japan; Yokohama, Kanagawa, Japan; Iruma, Saitama, Japan and 5 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 ClinicalTrials.gov; the study team decides eligibility.