Type 1 DiabetesEarly Phase 1NCT02641522
Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes
A Early Phase 1 study testing Siltuximab in people with Type 1 Diabetes, run by Carla Greenbaum, MD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of siltuximab on immune cell functions in patients with Type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Siltuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2016to 16 Mar 2017
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive for at least one diabetes-related autoantibody any time since diagnosis, including by not limited to: Glutamate decarboxylase (GAD-65) Insulin, if obtained within 10 days of the onset of exogenous insulin therapy; IA-2; ZnT8
- Peak stimulated C-peptide level ≥ 0.1 pmol/mL following a mixed meal tolerance test (MMTT) conducted within 60 days of enrollment
- Females of child-bearing potential must be willing to use effective birth control and refrain from donating eggs for the purposes of assisted reproduction for duration of study.
- A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at screening and prior to dosing.
- During the study, and for 3 months after receiving the study agent, a woman must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction.
- Willing and able to give informed consent for participation.
Who cannot join
- History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies;
- History of malignancy or serious uncontrolled cardiovascular disease or hypertension, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia despite therapy;
- Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections;
- History or serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C;
- Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection;
- Active infection with EBV ;
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- Active infection with CMV;
- Diagnosis of liver disease or elevated hepatic enzymes, confirmed by repeat tests, as defined by ALT, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > ULN;
- Any of the following hematologic abnormalities, confirmed by repeat tests:
- White blood count <3,000/μL or >14,000/μL
- Lymphocyte count <500/μL
- Platelet count <150,000 /μL
- Hemoglobin <8.5 g/dL or > or = to 17 g/dL
- Neutrophil count <2,000 cells/μL
- Females who are pregnant or lactating;
- Receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guérin, and small pox) in the 6 weeks before treatment;
- Receipt of non-live vaccine in the 4 weeks before treatment;
- Any medical or psychological condition that in the opinion of the Sponsor Investigator would interfere with the safe completion of the trial;
- Receipt of an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months or 5 half-lives before enrollment or is currently enrolled in the treatment stage of an investigational study;
- Receipt of any immune-modulating biologic drug within 3 months of enrolling in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Benaroya Research Institute
Seattle, Washington, 98101
About this study
The purpose of this study is to evaluate the effects of siltuximab on immune cell functions in patients with Type 1 diabetes (T1D).
Read the detailed description
This is an open-label (all people know the identity of the intervention), single center, non-randomized (patients are not assigned by chance to treatment groups), Mechanistic Study (a study that focuses on the biologic activity of the drug, rather than on disease treatment). Up to 10 patients with Type 1 diabetes (T1D) will be enrolled in the study. Participants will receive a single dose of siltuximab and blood samples will be obtained a total of 6 times until 12 weeks after dosing. Cells will be isolated from the blood samples and used to measure specific activities of cells in the immune system. Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. The end of study is the date of the last assessment for the last patient.
- Conditions
- Type 1 Diabetes
- Being tested
- Siltuximab
- Keywords
- T1D, Type 1 diabetes
- 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.
SiltuximabDrug
Also called Sylvant
Single infusion of siltuximab (11 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Post-Infusion | Experimental | Single infusion of siltuximab (11 mg/kg) Receives: Drug: Siltuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in IL-6 Stimulated Intracellular p-STAT3 at Week 12
Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline
Measured: 0-to-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start8 Mar 2016
- Primary completion16 Mar 2017
- Study completion16 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carla Greenbaum, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor-investigator, Carla Greenbaum, MD, Benaroya Research Institute
- Investigators
- Carla Greenbaum, MD, Principal investigator, Benaroya Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641522
- Sponsor's protocol ID
- EMU-002
- Status last verified
- Oct 2018
- First submitted
- 23 Dec 2015
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02641522
- Acronym / sponsor ID
- EMU-002
- Conditions
- Type 1 Diabetes
- Keywords
- T1D, Type 1 diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Carla Greenbaum, MDUniversity, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 9 Oct 2018
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 evaluate the effects of siltuximab on immune cell functions in patients with Type 1 diabetes (T1D).
Detailed description
This is an open-label (all people know the identity of the intervention), single center, non-randomized (patients are not assigned by chance to treatment groups), Mechanistic Study (a study that focuses on the biologic activity of the drug, rather than on disease treatment). Up to 10 patients with Type 1 diabetes (T1D) will be enrolled in the study. Participants will receive a single dose of siltuximab and blood samples will be obtained a total of 6 times until 12 weeks after dosing. Cells will be isolated from the blood samples and used to measure specific activities of cells in the immune system. Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. The end of study is the date of the last assessment for the last patient.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Infusion | Experimental | Drug: SiltuximabSingle infusion of siltuximab (11 mg/kg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Positive for at least one diabetes-related autoantibody any time since diagnosis, including by not limited to: Glutamate decarboxylase (GAD-65) Insulin, if obtained within 10 days of the onset of exogenous insulin therapy; IA-2; ZnT8
- Peak stimulated C-peptide level ≥ 0.1 pmol/mL following a mixed meal tolerance test (MMTT) conducted within 60 days of enrollment
- Females of child-bearing potential must be willing to use effective birth control and refrain from donating eggs for the purposes of assisted reproduction for duration of study.
- A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at screening and prior to dosing.
- During the study, and for 3 months after receiving the study agent, a woman must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction.
Key exclusion criteria (20 listed)
- History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies;
- History of malignancy or serious uncontrolled cardiovascular disease or hypertension, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia despite therapy;
- Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections;
- History or serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C;
- Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection;
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 |
|---|---|---|
| SiltuximabAlso: SylvantSingle infusion of siltuximab (11 mg/kg) | Drug | Post-Infusion |
Primary outcome
Percent Change From Baseline in IL-6 Stimulated Intracellular p-STAT3 at Week 12
Time frame: 0-to-12 weeks
Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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
1 site 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 Siltuximab in people with Type 1 Diabetes, run by Carla Greenbaum, MD at 1 site 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 6 inclusion and 20 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in IL-6 Stimulated Intracellular p-STAT3 at Week 12 (time frame: 0-to-12 weeks). 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 2 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.