Type 1 Diabetes MellitusPhase 2KIBOU-T1DNCT06791291
Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
A Phase 2 study testing Teplizumab in people with Type 1 Diabetes Mellitus, run by Sanofi at 11 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 34 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Teplizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 11 sitesJapan
- Study dates
- 25 Jul 2025to 6 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 34 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to 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 ethnic Japanese grandparents who were all born in Japan.
- 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 decarboxylase), anti-IA2 (insulinoma-associated antigen 2), anti-insulin, anti-ZnT8 (zinc transporter 8), and/or ICA (islet cell antibody).
- 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 Abbreviation \t "electrocardiogram" .
- Participant is up to date with routine age-appropriate immunizations according to current local specific guideline prior to randomization.
Show all 50Show fewer
- 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 one of the following conditions applies:
- 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 contraceptive method, from signing of the informed consent to at least 3 months and 2 weeks after randomization and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
- A WOCBP must have at least a negative highly sensitive pregnancy test within 48 hours before the administration of study intervention.
- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a blood pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Participants are excluded from the study if any of the following criteria apply:
- Any presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic (except Stage 2 T1D), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- 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 weeks prior to Screening. Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).
- 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 donation of any volume within 16 weeks before randomization; for any participant, blood transfusion (any volume) within 2 months before randomization.
- 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 components of the teplizumab injection (including sodium phosphate, sodium chloride, polysorbate 80).
- 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 screening.
- 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 carcinoma of the skin).
- 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 weeks before randomization; or with other frequent recurrent infections deemed unacceptable as per Investigator's judgement.
- 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 topical, or systemic glucocorticoids.
- 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, niacin etc.).
- 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 randomization.
- 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 according to applicable regulations (eg, having received an IMP of new active pharmaceutical ingredient (API) within 4 months or that of an approved API within 3 months before the administration of this study's IMP).
- 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 above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
11 sites in 1 country
Japan11 sites, 6 recruiting
- Active, not recruiting
Investigational Site Number : 3920010
Chūō, Yamanashi, 409-3898
- Recruiting
Investigational Site Number : 3920017
Fukuoka, 812-0025
- Active, not recruiting
Investigational Site Number : 3920001
Iruma, Saitama, 350-0495
- Active, not recruiting
Investigational Site Number : 3920018
Kobe, Hyōgo, 650-0017
- Active, not recruiting
Investigational Site Number : 3920016
Kyoto, 606-8507
- Active, not recruiting
Investigational Site Number : 3920014
Nagasaki, 852-8501
- Recruiting
Investigational Site Number : 3920004
Osaka, 545-8586
- Recruiting
Investigational Site Number : 3920006
Sapporo, Hokkaido, 060-8543
- Recruiting
Investigational Site Number : 3920020
Tokyo, 101-8309
- Recruiting
Investigational Site Number : 3920003
Tokyo, 162-8666
- Recruiting
Investigational Site Number : 3920019
Yokohama, Kanagawa, 222-0036
About this study
Official title: Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 1 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.
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. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA.
Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 1 to 34 years.
Read the detailed description
Total study duration is approximately 756 days.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Teplizumab
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeplizumabDrug
Also called SAR446681, TZIELD
Pharmaceutical form:Solution for injection-Route of administration:Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Teplizumab | Experimental | Participants will receive Teplizumab via IV infusion Receives: Drug: Teplizumab |
| Control | No intervention | Participants will receive no treatment in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria
Measured: From baseline up to Week 104
Change from baseline in area under the curve (AUC) of C-peptide
Measured: From baseline up to Week 104
Change from baseline in AUC of endogenous insulin
Measured: From baseline up to Week 104
Number of participants with TEAEs, SAEs, AEs leading to permanent study intervention- or study discontinuation; AEs of special interest; number of participants with clinically significant changes in vital signs, ECG, and/or safety laboratory test
TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event
Measured: Throughout the study, approximately 756 days
Secondary outcomes (6)
Change from baseline in fasting plasma glucose (FPG) from an oral glucose tolerance test
Measured: From baseline up to Week 104
Change from baseline in 2-hour plasma glucose from an oral glucose tolerance test
Measured: From baseline up to Week 104
Change from baseline of hemoglobin A1c (HbA1c)
Measured: From baseline up to Week 104
Serum concentration of teplizumab
Measured: From Day 1 to Day 28
Number of participants with anti-drug antibodies
Measured: From baseline up to Week 104
Number of participants with neutralizing antibodies
Measured: From baseline up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start25 Jul 2025
- Primary completion6 Mar 2028 (estimated)
- Study completion6 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791291
- Sponsor's protocol ID
- ACT18487
- Other IDs
- U1111-1308-1324, jRCT2031240637
- Acronym
- KIBOU-T1D
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 1 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.
- ClinicalTrials.gov ID
- NCT06791291
- Acronym / sponsor ID
- KIBOU-T1D / ACT18487
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 6 Mar 2028 (estimated)
- Study completion
- 6 Mar 2028 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA.
Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 1 to 34 years.
Detailed description
Total study duration is approximately 756 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teplizumab | Experimental | Drug: TeplizumabParticipants will receive Teplizumab via IV infusion |
| Control | No intervention | –Participants will receive no treatment in the control group |
Who may qualify
- Ages
- 1 year to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (50 listed)
- 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 ethnic Japanese grandparents who were all born in Japan.
- 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 decarboxylase), anti-IA2 (insulinoma-associated antigen 2), anti-insulin, anti-ZnT8 (zinc transporter 8), and/or ICA (islet cell antibody).
- 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 Abbreviation \t "electrocardiogram" .
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeplizumabAlso: SAR446681, TZIELDPharmaceutical form:Solution for injection-Route of administration:Intravenous infusion | Drug | Teplizumab |
Primary outcome
Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria
Time frame: From baseline up to Week 104
Change from baseline in area under the curve (AUC) of C-peptide
Time frame: From baseline up to Week 104
Change from baseline in AUC of endogenous insulin
Time frame: From baseline up to Week 104
Number of participants with TEAEs, SAEs, AEs leading to permanent study intervention- or study discontinuation; AEs of special interest; number of participants with clinically significant changes in vital signs, ECG, and/or safety laboratory test
Time frame: Throughout the study, approximately 756 days
TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event
6 secondary outcomes
Change from baseline in fasting plasma glucose (FPG) from an oral glucose tolerance test
Time frame: From baseline up to Week 104
Change from baseline in 2-hour plasma glucose from an oral glucose tolerance test
Time frame: From baseline up to Week 104
Change from baseline of hemoglobin A1c (HbA1c)
Time frame: From baseline up to Week 104
Serum concentration of teplizumab
Time frame: From Day 1 to Day 28
Number of participants with anti-drug antibodies
Time frame: From baseline up to Week 104
Number of participants with neutralizing antibodies
Time frame: From baseline up to Week 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- ACT18487 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teplizumab in people with Type 1 Diabetes Mellitus, run by Sanofi at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 50 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria (time frame: From baseline up to Week 104). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.