Type 1 Diabetes MellitusPhase 2TN40ANCT07216391
Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
A Phase 2 study testing Antithymocyte Globulin (ATG) and Teplizumab in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 6 sites in United States.
Trial summary
This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration… Read more about this study
- Who is it for?
- Ages 4 to 34 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Antithymocyte Globulin (ATG) and Teplizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Jul 2026to 30 May 2030
- 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 4 to 34 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is <18 years of age.
- Aged ≥4 to <35 years
- A history of at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this trial.
- Participants must meet ADA stage 2 T1D glycemic criteria* by TrialNet testing within 100 days of the baseline visit.
- The ADA definition of stage 2 T1D is characterized by glucose intolerance or dysglycemia in the presence of two or more islet autoantibodies, impaired fasting glucose (≥ 100mg/dL), impaired glucose tolerance (2-hour post 75g glucose load ≥ 140mg/dL), high glucose levels at intermediate time points on OGTT (30, 60, 90 min timepoints of ≥ 200 mg/dL), and/or HbA1c between 5.7% and 6.4% or ≥ 10% increase in HbA1c within a two year window, with the most recent HbA1c value obtained within 100 days of the baseline visit.
- Participants, regardless of serostatus, must meet all of the following:
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- Be EBV and CMV PCR negative prior to randomization
- Be EBV and CMV PCR negative within 2 weeks prior to the baseline visit
- Have no signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days prior to the baseline visit.
- Be at least 8 weeks from last live immunization at the time of the baseline visit.
- Be willing to forgo vaccines (other than non-live influenza and COVID-19) during the 3 months after study drug treatment period and forgo live vaccines for 12 months after study drug treatment period.
- Must meet TrialNet eligibility minimum immunization recommendations found in Appendix A of the manual of operations (MOO).
- With the exception of stage 2 T1D, participants must be healthy, as defined by absence of any other untreated diagnoses that the investigator deems to be a potential confounder.
- If a female participant with reproductive potential, willing to avoid pregnancy (abstinence or adequate contraceptive method) through the completion of the study infusions and up to 3 months after study drug administration and undergo pregnancy testing prior to each study visit.
- Must be residing or have accommodations within 1 hour of the infusion site during study drug infusions and must be within 1 hour of a medical care facility for 1 day after completion of infusions.
- Participants must live in a location with rapid access to emergency medical services.
Who cannot join
- Immunodeficiency or clinically significant chronic lymphopenia: (Leukopenia (<3,000 leukocytes/μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<1000 lymphocytes/μL), thrombocytopenia (<150,000 platelets/μL).
- Hemoglobin less than 13 g/dL for adult men and less than 11.5g/dL for adult females and less than 11 g/dL for participants under age 18.
- Active signs or symptoms of acute or chronic infection at the time of the baseline visit including SARS-Cov-2.
- Uncontrolled autoimmune thyroid disease and/or celiac disease (participants must be well controlled for the previous 6 months).
- Evidence of prior or current tuberculosis infection through any one or more of the following:
- A history of latent or active TB
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- Signs and/or symptoms of TB
- Recent close contact with a person with known or suspected active TB unless appropriate prophylaxis for TB was given
- A history of a chest X-ray consistent with active TB or old, inactive TB, or interferon gamma release assay IGRA (QuantiFERON) test
- A history of a positive purified protein derivative (PPD) skin test result (>10 mm induration), or positive/repeatedly indeterminate on an interferon-gamma release assay (IGRA; e.g., QuantiFERON-TB test).
- Currently pregnant or lactating or anticipate getting pregnant within the study period.
- Require use of other immunosuppressive agents including chronic use of oral or intravenous injectable steroids.
- Evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.
- Any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, COPD, sickle cell disease, Down syndrome, adrenal insufficiency, neurological disease, or blood count abnormalities.
- A history of malignancies other than of skin.
- Evidence of liver dysfunction with AST or ALT ≥ 2 times the upper limit of the reference range.
- Evidence of renal dysfunction with creatinine ≥ 1.5 times the upper limit of the reference range.
- Increased bilirubin ≥ 2 times (total) or ≥ 1.5 times (direct) the normal limit (Participants with documentation of Gilbert's Disease permitted).
- Vaccination with a live vaccine within the last 8 weeks or killed/inactivated vaccine within the last 2 weeks of the baseline visit.
- Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 14 days of screening.
- Prior treatment with Teplizumab or ATG (either in a previous clinical trial or clinically).
- Has previously participated in a clinical trial for diabetes prevention and received active study agent within 6 months of treatment.
- Known allergy to rabbits or rabbit derived products.
- Prior adverse reactions to heparin.
- Any condition that in the investigator's opinion may adversely affect study participation.
- Any screening/baseline laboratory result not otherwise stated out of normal reference range and/or medical history that may increase the risk of the participant's participation in this trial.
- Previously diagnosed with Stage 3 TID according to ADA criteria.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Barbara Davis Center
Aurora, Colorado, 80045
Leah Galvez Valencia, 303-724-4992, leah.galvezvalencia@ucdenver.edu
Lexie Chesshir, 303-724-8615, lexie.chesshir@CUANSCHUTZ.EDU
- Recruiting
University of Florida
Gainesville, Florida, 32610
Jennifer Hosford, (352) 294-5759, jennifer.hosford@medicine.ufl.edu
Danielle Poulton, 352-294-5761, Danielle.Poulton@medicine.ufl.edu
- Recruiting
Yale University
New Haven, Connecticut, 06511
Marcia DeSousa, 203-737-4805, marcia.desousa@yale.edu
Jennifer Sherr, MD
- Recruiting
Columbia University
New York, New York, 10032
Amy Doytchinov, 212-851-5494, as8064@cumc.columbia.edu
Cecelia Lim, 212-851-5494, cl4874@cumc.columbia.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Kelli DeLallo, 412-692-5210, kelli.delallo@chp.edu
Ingrid Libman, MD
- Recruiting
Benaroya Research Institute
Seattle, Washington, 98101
Arlene Colmenares, (206) 287-5627, AColmenares@benaroyaresearch.org
Kimberly Varner, 206-341-8934, kvarner@benaroyaresearch.org
About this study
Official title: Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A
This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstrates a positive signal and as decided by TrialNet, there is potential for a study extention. This would extend follow-up visits for a possible study duration of about 9 years among the earliest enrollees of the initial study.
Read the detailed description
This protocol will enroll 60 participants between the ages of 4 and 34 with Stage 2 Type 1 diabetes. Oral glucose tolerance testing will be done at the screening, baseline visit (V0) and at 3, 6 and 12 months in the first year after study drug administration. Eligible study participants will be randomized to recieve either 2 doses of ATG over 2-3 days or 14 doses of teplizumab given once daily over 14 consecutive days. Safety labs will also be done during select study visits to monitor the participant's health. Once the treatment phase has been completed, participants will have 3 in-person study visits in year one of the study with interim contact to assess adverse events and symptoms of diabetes. After year one of the study, participants will continue in-person follow-up visits every 6 months until the last enrolled participant completes the 12-month visit or develops Stage 3 Type 1 diabetes, whichever occurs first. The total initial study duration is expected to last 3-4 years. There is a possibility the study will be extended after the initial study duration, dependent upon the primary outcome (DPTRS at the month 6 visit) and as determined by TrialNet. If the study extension is done, participants would be presented an additional consent form to opt into additional follow-up visits which would increase total time in study to about 9 years.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Antithymocyte Globulin (ATG), Teplizumab
- Keywords
- TrialNet, T1D, Teplizumab, ATG
- 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.
Antithymocyte Globulin (ATG)Drug
Thymoglobulin
TeplizumabDrug
Intravenous infusions of teplizumab given for 14 consecutive days. For participants ages 8-34 each infusion will take a minimum of 30 minutes. For participants ages 4-7 each infusion will take a minimum of 2 hours. Each infusion will also be followed by an observation period of at least 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ATG | Experimental | Antithymocyte globulin (ATG) will be intravenously administered over two days, with a total of 2 infusion periods. The first dose (0.5mg/kg) will be infused over a minimum of 6 hours, and the second dose (2mg/kg) over a minimum of 4 hours with a maximum infusion time for each infusion of 10 hours. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion. Receives: Drug: Antithymocyte Globulin (ATG) |
| Teplizumab | Active comparator | Intravenous infusions of teplizumab will be given for 14 consecutive days. For participants between the ages of 8-34 each infusion will be given over a minimum of 30 minutes. For participants between the ages of 4-7 the infusion will be given over a minimum of 2 hours. Vital signs will be monitored for at least 30 minutes after each infusion. If reactions to the infusion occur participants may be monitored for at least 2 hours after the study drug infusion. The total dose for the 14-day course is approximately 11,240 µg/m². Receives: Drug: Teplizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DPTRS at six months
DPTRS is calculated as DPTRS = (1.569 x log-BMI) - (0.056 x age) + (0.813 x glucose sum from 30 to 120 min /100) - (0.848 x C-peptide sum from 30 to 120 min/10) + (0.476 x log-fasting C-peptide), where the units are years for age, kg/m2 for BMI, mg/dl for glucose, ng/ml for C-peptide
Measured: 6 months after completion of study drug administration
Secondary outcomes (7)
Progression to Stage 3 T1D
Elapsed time from study drug administration to the development of diabetes or time of last contact among those randomized
Measured: 6 months after study drug administration
OGTT glucose AUC
Mean area under the stimulated glucose curve (AUC) over the 2-hour oral glucose tolerance test.
Measured: 6 months after study drug administration
M120 score
This is an aggregated score from multiple measurements calculated as follows:
M120 = 0.448×(sex) + 0.631×(IA-2A) - 0.0302×(age) + 0.0605×(BMI)
+ 1.380×(HbA1c) + 0.0265×(120 min glucose) - 0.191×(120 min C-peptide), where the units for BMI, age, glucose, C-peptide and HbA1c are, respectively, kg/m2, years, mg/dl, ng/ml and percentage units. Sex was assigned a score of 1 for male and 2 for female, and IA-2A status assigned 0 for absent and 1 for present. Glucose is converted from mmol/l to mg/dl by multiplying by 18; C-peptide is converted from nmol/l to ng/ml by dividing by 3.00; and HbA1c is converted from mmol/mol to percentage units by adding 23.5 and then dividing by 10.93.
Measured: 6 months after study drug administration
Index 60
This is an aggregated score from multiple measurements calculated as follows:
Index60 = 0.3695×loge(fasting C-peptide) + 0.0165×(60 min glucose) - 0.3644×(60 min C-peptide), where the units for glucose and C-peptide are, respectively, mg/dl and ng/ml. Glucose is converted from mmol/l to mg/dl by multiplying by 18; C-peptide is converted from nmol/l to ng/ml by dividing by 3.00.
Measured: 6 months after study drug administration
OGTT C-peptide AUC
Mean area under the stimulated C-peptide curve (AUC) over the 2-hour oral glucose tolerance test
Measured: 6 months after study drug administration
HbA1c
Measured as a percentage of total hemoglobin
Measured: 6 months after study drug administration
Continuous Glucose Monitoring (CGM)
Measures of CGM glucose range and variability
Measured: 6 months after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start29 Jul 2026
- Primary completion30 Nov 2029 (estimated)
- Study completion30 May 2030 (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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial will enroll 60 participants who will be randomly assigned in a 2:1 allocation to the following treatment arms: 40 participants will be randomized to ATG and 20 participants will be randomized to teplizumab.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael Haller, MD, Study director, TrialNet ChairmanDavid Baidal, MD, Study chair, TrialNetVandana Raman, MD, MBBS, Study chair, TrialNet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216391
- Sponsor's protocol ID
- TN40A
- Acronym
- TN40A
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available at the NIDDK Central Repository
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A
- ClinicalTrials.gov ID
- NCT07216391
- Acronym / sponsor ID
- TN40A / TN40A
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- TrialNet, T1D, Teplizumab, ATG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 14 Oct 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 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstrates a positive signal and as decided by TrialNet, there is potential for a study extention. This would extend follow-up visits for a possible study duration of about 9 years among the earliest enrollees of the initial study.
Detailed description
This protocol will enroll 60 participants between the ages of 4 and 34 with Stage 2 Type 1 diabetes. Oral glucose tolerance testing will be done at the screening, baseline visit (V0) and at 3, 6 and 12 months in the first year after study drug administration. Eligible study participants will be randomized to recieve either 2 doses of ATG over 2-3 days or 14 doses of teplizumab given once daily over 14 consecutive days. Safety labs will also be done during select study visits to monitor the participant's health. Once the treatment phase has been completed, participants will have 3 in-person study visits in year one of the study with interim contact to assess adverse events and symptoms of diabetes. After year one of the study, participants will continue in-person follow-up visits every 6 months until the last enrolled participant completes the 12-month visit or develops Stage 3 Type 1 diabetes, whichever occurs first. The total initial study duration is expected to last 3-4 years. There is a possibility the study will be extended after the initial study duration, dependent upon the primary outcome (DPTRS at the month 6 visit) and as determined by TrialNet. If the study extension is done, participants would be presented an additional consent form to opt into additional follow-up visits which would increase total time in study to about 9 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial will enroll 60 participants who will be randomly assigned in a 2:1 allocation to the following treatment arms: 40 participants will be randomized to ATG and 20 participants will be randomized to teplizumab.
| Arm | Type | Receives |
|---|---|---|
| ATG | Experimental | Drug: Antithymocyte Globulin (ATG)Antithymocyte globulin (ATG) will be intravenously administered over two days, with a total of 2 infusion periods. The first dose (0.5mg/kg) will be infused over a minimum of 6 hours, and the second dose (2mg/kg) over a minimum of 4 hours with a maximum infusion time for each infusion of 10 hours. Infusions may be administered either in a hospital or outpatient setting at the investigator's or institutions discretion. |
| Teplizumab | Active comparator | Drug: TeplizumabIntravenous infusions of teplizumab will be given for 14 consecutive days. For participants between the ages of 8-34 each infusion will be given over a minimum of 30 minutes. For participants between the ages of 4-7 the infusion will be given over a minimum of 2 hours. Vital signs will be monitored for at least 30 minutes after each infusion. If reactions to the infusion occur participants may be monitored for at least 2 hours after the study drug infusion. The total dose for the 14-day course is approximately 11,240 µg/m². |
Who may qualify
- Ages
- 4 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is <18 years of age.
- Aged ≥4 to <35 years
- A history of at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this trial.
- Participants must meet ADA stage 2 T1D glycemic criteria* by TrialNet testing within 100 days of the baseline visit.
- The ADA definition of stage 2 T1D is characterized by glucose intolerance or dysglycemia in the presence of two or more islet autoantibodies, impaired fasting glucose (≥ 100mg/dL), impaired glucose tolerance (2-hour post 75g glucose load ≥ 140mg/dL), high glucose levels at intermediate time points on OGTT (30, 60, 90 min timepoints of ≥ 200 mg/dL), and/or HbA1c between 5.7% and 6.4% or ≥ 10% increase in HbA1c within a two year window, with the most recent HbA1c value obtained within 100 days of the baseline visit.
Key exclusion criteria (27 listed)
- Immunodeficiency or clinically significant chronic lymphopenia: (Leukopenia (<3,000 leukocytes/μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<1000 lymphocytes/μL), thrombocytopenia (<150,000 platelets/μL).
- Hemoglobin less than 13 g/dL for adult men and less than 11.5g/dL for adult females and less than 11 g/dL for participants under age 18.
- Active signs or symptoms of acute or chronic infection at the time of the baseline visit including SARS-Cov-2.
- Uncontrolled autoimmune thyroid disease and/or celiac disease (participants must be well controlled for the previous 6 months).
- Evidence of prior or current tuberculosis infection through any one or more of the following:
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 |
|---|---|---|
| Antithymocyte Globulin (ATG)Thymoglobulin | Drug | ATG |
| TeplizumabIntravenous infusions of teplizumab given for 14 consecutive days. For participants ages 8-34 each infusion will take a minimum of 30 minutes. For participants ages 4-7 each infusion will take a minimum of 2 hours. Each infusion will also be followed by an observation period of at least 30 minutes. | Drug | Teplizumab |
Primary outcome
Change in DPTRS at six months
Time frame: 6 months after completion of study drug administration
DPTRS is calculated as DPTRS = (1.569 x log-BMI) - (0.056 x age) + (0.813 x glucose sum from 30 to 120 min /100) - (0.848 x C-peptide sum from 30 to 120 min/10) + (0.476 x log-fasting C-peptide), where the units are years for age, kg/m2 for BMI, mg/dl for glucose, ng/ml for C-peptide
7 secondary outcomes
Progression to Stage 3 T1D
Time frame: 6 months after study drug administration
OGTT glucose AUC
Time frame: 6 months after study drug administration
M120 score
Time frame: 6 months after study drug administration
Index 60
Time frame: 6 months after study drug administration
OGTT C-peptide AUC
Time frame: 6 months after study drug administration
HbA1c
Time frame: 6 months after study drug administration
Continuous Glucose Monitoring (CGM)
Time frame: 6 months after study drug administration
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 9 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available at the NIDDK Central Repository
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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.
Michael Haller, MD study director
TrialNet Chairman
David Baidal, MD study chair
TrialNet
Vandana Raman, MD, MBBS study chair
TrialNet
6 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 Antithymocyte Globulin (ATG) and Teplizumab in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 6 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 16 inclusion and 27 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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 Melissa Parker (813-396-9378, melissa.parker@epi.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DPTRS at six months (time frame: 6 months after completion of study drug administration). 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 9 Sep 2026.