Type 1 DiabetesEarly Phase 1NCT04118153
Early Markers of Disease and Response to Therapy
A Early Phase 1 study testing Abatacept in people with Type 1 Diabetes, run by Sandra Lord, MD at 2 sites in United States.
Trial summary
The purpose of this study is to identify early immune markers associated with response to treatment with abatacept in individuals with Type 1 diabetes (T1D). In this open label mechanistic study, participants who were recently diagnosed with T1D (males or females, ages 6-45 and <7months from T1D diagnosis) will be… Read more about this study
- Who is it for?
- Ages 6 to 55 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Mar 2021to 24 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 6 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≤ 7 months from type 1 diabetes diagnosis based on ADA criteria
- > 21 days from type 1 diabetes diagnosis or metabolically stable per study physician assessment
- Males and females 6-55 years of age, inclusive, at time of screening visit
- Peak MMTT stimulated C-peptide ≥ 0.2 pmol/ml
- Females of child-bearing age must be willing to use effective birth control for 1 year (which may include abstinence) from screening visit and undergo regular pregnancy testing
- Up to date for clinically recommended immunizations prior to screening
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- Willing to forgo live vaccines 3 months prior to the screening visit until three months following last study drug administration
- Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is < 18 years of age
- Weight ≥ 20 kg at baseline visit
- HbA1c ≤ 8.5% at baseline visit
- Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy)
Who cannot join
- Concurrent or recent (within the past 30 days of screening MMTT (visit -1)) use of non-insulin therapies aimed to control hyperglycemia
- Females who are pregnant or lactating
- Immunodeficiency or clinically significant chronic lymphopenia
- Have an active infection at time of screening or baseline visit
- Recent exposure, or possible or known active SARS-CoV-2 infection as defined by public health guidelines
- Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection
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- Active infection with EBV or CMV, defined by real-time PCR
- History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac disease and stable thyroid disease
- Require use of other immunosuppressive agents for any other condition
- Use of medications known to influence glucose tolerance
- Have any complicating medical or psychological issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. These include pre-existing cardiac disease, COPD, neurological, or clinically significant blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia).
- Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection.
- Have a history of malignancies
- Receipt of live vaccine (MMR, intranasal influenza, varicella, rotatvirus) in 3 months before treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Benaroya Research Institute
Seattle, Washington, 98101
About this study
The purpose of this study is to identify early immune markers associated with response to treatment with abatacept in individuals with Type 1 diabetes (T1D). In this open label mechanistic study, participants who were recently diagnosed with T1D (males or females, ages 6-45 and <7months from T1D diagnosis) will be treated with a short-course of abatacept (weekly subcutaneous injections for 3 months). Participants will undergo baseline and repeated mixed meal tolerance testing (MMTT) to assess disease progression and blood samples will be obtained at frequent intervals to measure changes in immune markers.
- Conditions
- Type 1 Diabetes
- Being tested
- Abatacept
- 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.
AbataceptDrug
Also called ORENCIA
Abatacept will be administered by subcutaneous injections weekly for 3 months. Dosing is according to body weight at screening visit and will be administered as follows: up to 25 kg receive 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL) per dose.
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | Abatacept will be given by a subcutaneous (SC) formulation weekly for three months. Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin antibody titers (NIDDK units/mL)
Insulin antibody titers
Measured: 0 to 2 weeks
Change in frequency of B cells within total PBMC (%)
% of B cells
Measured: 0 to 2 weeks
Change in inflammatory Index by serum transcriptional exposure assay (composite score)
Inflammatory Index (359). This is an inflammatory index based on transcription of 359 probe sets (I.I.359) calculated by dividing the average signal intensity of the 103 probe sets generally annotated as 'inflammatory' by the average signal intensity of the 256 probe sets generally annotated as 'regulatory'
Measured: 0 to 2 weeks
Change in B-cell transcriptional module (CD19.mod) (composite score)
CD19 mod is composite score of B cell transcripts.
Measured: 0 to 2 weeks
Change in islet-specific exhausted CD8 T cells (%)
% of CD8+ T cells (CD8+PD-1+KLRG1+CD57-)
Measured: 0 to 2 weeks
Change in EOMES CD8 whole blood gene expression signature (composite score)
Gene transcript score for EOMES module
Measured: 0 to 2 weeks
Change in frequency of TfH within total CD4 T cells (%)
% of TfH cells within CD4+ T cells
Measured: 0 to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start5 Mar 2021
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandra Lord, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Medical College of Wisconsin
- Responsible party
- Sponsor-investigator, Sandra Lord, MD, Benaroya Research Institute
- Investigators
- Carla Greenbaum, MD, Principal investigator, Benaroya Research Institute at Virginia Mason
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118153
- Sponsor's protocol ID
- DREAMT V1.0
- Status last verified
- May 2024
- First submitted
- 2 Oct 2019
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Markers of Disease and Response to Therapy
- ClinicalTrials.gov ID
- NCT04118153
- Acronym / sponsor ID
- DREAMT V1.0
- Conditions
- Type 1 Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sandra Lord, MDUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Medical College of Wisconsin
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 8 Oct 2019 (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.
The purpose of this study is to identify early immune markers associated with response to treatment with abatacept in individuals with Type 1 diabetes (T1D). In this open label mechanistic study, participants who were recently diagnosed with T1D (males or females, ages 6-45 and <7months from T1D diagnosis) will be treated with a short-course of abatacept (weekly subcutaneous injections for 3 months). Participants will undergo baseline and repeated mixed meal tolerance testing (MMTT) to assess disease progression and blood samples will be obtained at frequent intervals to measure changes in immune markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Drug: AbataceptAbatacept will be given by a subcutaneous (SC) formulation weekly for three months. |
Who may qualify
- Ages
- 6 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- ≤ 7 months from type 1 diabetes diagnosis based on ADA criteria
- > 21 days from type 1 diabetes diagnosis or metabolically stable per study physician assessment
- Males and females 6-55 years of age, inclusive, at time of screening visit
- Peak MMTT stimulated C-peptide ≥ 0.2 pmol/ml
- Females of child-bearing age must be willing to use effective birth control for 1 year (which may include abstinence) from screening visit and undergo regular pregnancy testing
Key exclusion criteria (14 listed)
- Concurrent or recent (within the past 30 days of screening MMTT (visit -1)) use of non-insulin therapies aimed to control hyperglycemia
- Females who are pregnant or lactating
- Immunodeficiency or clinically significant chronic lymphopenia
- Have an active infection at time of screening or baseline visit
- Recent exposure, or possible or known active SARS-CoV-2 infection as defined by public health guidelines
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 |
|---|---|---|
| AbataceptAlso: ORENCIAAbatacept will be administered by subcutaneous injections weekly for 3 months. Dosing is according to body weight at screening visit and will be administered as follows: up to 25 kg receive 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL) per dose. | Drug | Abatacept |
Primary outcome
Change in insulin antibody titers (NIDDK units/mL)
Time frame: 0 to 2 weeks
Insulin antibody titers
Change in frequency of B cells within total PBMC (%)
Time frame: 0 to 2 weeks
% of B cells
Change in inflammatory Index by serum transcriptional exposure assay (composite score)
Time frame: 0 to 2 weeks
Inflammatory Index (359). This is an inflammatory index based on transcription of 359 probe sets (I.I.359) calculated by dividing the average signal intensity of the 103 probe sets generally annotated as 'inflammatory' by the average signal intensity of the 256 probe sets generally annotated as 'regulatory'
Change in B-cell transcriptional module (CD19.mod) (composite score)
Time frame: 0 to 2 weeks
CD19 mod is composite score of B cell transcripts.
Change in islet-specific exhausted CD8 T cells (%)
Time frame: 0 to 2 weeks
% of CD8+ T cells (CD8+PD-1+KLRG1+CD57-)
Change in EOMES CD8 whole blood gene expression signature (composite score)
Time frame: 0 to 2 weeks
Gene transcript score for EOMES module
Change in frequency of TfH within total CD4 T cells (%)
Time frame: 0 to 2 weeks
% of TfH cells within CD4+ T cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Carla Greenbaum, MD principal investigator
Benaroya Research Institute at Virginia Mason
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Abatacept in people with Type 1 Diabetes, run by Sandra Lord, MD at 2 sites in United States.
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 11 inclusion and 14 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: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin antibody titers (NIDDK units/mL) (time frame: 0 to 2 weeks). The study lists 7 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 4 Jun 2024.