Type 1 Diabetes study: High Dose SAB-142 vs Low Dose SAB-142
Official title SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes
ClinicalTrials.gov ID: NCT07187531
What this study is testing
What is High Dose SAB-142?
This is an investigational medicine being studied to see if it helps people with new onset Type 1 Diabetes.
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 study aims to find out if the drug SAB 142 is safe and if it can help stop Type 1 Diabetes from getting worse right after diagnosis.
- Who it's for
- The study is looking for people who have just been diagnosed with Type 1 Diabetes.
- What's involved
- Participants will receive either the new drug SAB 142 or a placebo (a fake treatment with no active ingredients) and undergo regular health checks to monitor their condition.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 40
You may be able to join if
- Participant and/or appropriate legal guardian for participants below the legal age of consent must have given written informed consent and/or assent...
- Males and females 15-40 years old at the time of randomisation in Part A.
- Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) from 16 to 32 (inclusive).
- Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization.
- Participant has random C-peptide levels of ≥0.2 nmol/L, measured during Screening. One random C-peptide retest during screening period is allowed.
You likely can't join if
- Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies...
- Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.
- Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening...
- Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.
- Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic...
- Participant has any autoimmune disease other than T1D (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis...
See the full eligibility criteria
Who can join
- Participant and/or appropriate legal guardian for participants below the legal age of consent must have given written informed consent and/or assent according to local, regional and/or country specific guidance before...
- Males and females 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old\ , inclusive, at the time of randomisation in Part B.
- Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) from 16 to 32 (inclusive).
- Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization.
- Participant has random C-peptide levels of ≥0.2 nmol/L, measured during Screening. One random C-peptide retest during screening period is allowed.
- Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.
- Glutamic acid decarboxylase 65 (GAD65)
- Islet antigen 2 (IA-2)
- Zinc transporter 8 (ZnT8)
- Insulin autoantibodies (if testing within the first 14 days of insulin treatment)
- Female participants: a. Must be of nonchildbearing potential, i.e., pre-pubertal\ , surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or...
- Agree not to donate sperm from the time of signing the consent form until EOS.
- If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from...
- If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until EOS.
- Prior to receiving study drug, participant must agree to receive locally, regionally and/or country-specific required age-appropriate immunisations.
- Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and/or...
- Participant has suitable venous access for blood sampling.
- Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
- Part C: Participant has completed Month 12 assessments for Part A and Part B and meets all applicable eligibility requirements for participation in Part C.
What rules you out
- Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of...
- Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.
- Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV) 2 (Parts A and B) or 28 days prior to Day 1, TP3 (Part C)
- Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.
- Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the...
- Participant has any autoimmune disease other than T1D (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus...
- Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or...
- Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.
- 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.
- Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalization or IV anti-infective treatments or significant acute or chronic viral (including history of...
- Participant has a diagnosis of significant liver disease or at screening ALT and/or AST \>2× or total bilirubin of \>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the central laboratory and...
- Lymphocyte count: \<1000/μL
- Neutrophil count: \<1500/μL
- Platelet count: \<100 000 platelets/μL
- Haemoglobin: \<10 g/dL Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and/or is heretofore unrecognised should be considered in individuals who have one or...
- Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic...
- Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides...
- Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of any medication known to significantly influence glucose tolerance (e.g., atypical...
- Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact to investigational drug.
- Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): From 30 days before dosing through 6 months following administration or SAB-142 for each TP.
- Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing
- Recombinant, inactivated or otherwise "non-live" vaccines: Within the 30 days before dosing before dosing or within 30 days following dosing; or planned/required within 30 days prior to or 30 days following Day 1 of TP.
- Female is lactating and/or plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.
- An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and/or country...
- An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.
- An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site.
- An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI, or if participation in the study may place the participant at risk.
- An individual who has been placed in an institute by official or court order.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Aurora, Colorado, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- Albuquerque, New Mexico, United States
- Buffalo, New York, United States
- Asheville, North Carolina, United States
- Chapel Hill, North Carolina, United States
- Fargo, North Dakota, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
+ 42 more site(s).
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, but 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, 5 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Aurora, Colorado, United States; Gainesville, Florida, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States and 56 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.