Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.
Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Tocilizumab (TCZ)
- drug: Placebo
- other: Standard of Care
Eligibility
Inclusion Criteria:
1. Male or female aged 6-45 years*
-*Current Institutional Review Board (IRB)-approved age eligibility criteria is
restricted to subjects 6 to 17 years of age at time of study enrollment
2. Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association
T1DM criteria, within 100 days of study enrollment
3. Positive for at least one diabetes-related autoantibody, including but not limited to:
1. Glutamate decarboxylase (GAD-65)
2. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
3. Insulinoma antigen-2 (IA-2)
4. Zinc transporter-8 (ZnT8)
4. Peak stimulated C-peptide level ≥ 0.2 pmol/mL following a mixed-meal tolerance test
(MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
(V0)
5. Signed informed consent (and informed assent of minor, if applicable).
Exclusion Criteria:
1. Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
2. History of malignancy or serious uncontrolled cardiovascular, nervous system,
pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
3. Any history of recent serious bacterial, viral, fungal, or other opportunistic
infections
4. Have serologic evidence of current or past HIV (Human immunodeficiency virus),
Hepatitis B, or Hepatitis C
5. Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
6. Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load ≥10,000
copies per mL of whole blood
7. Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥10,000
copies per mL of whole blood
8. Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine
aminotransferase (ALT), Aspartate aminotransferase (AST), or both > 1.5 x the upper
limit of age-determined normal (ULN) or total bilirubin > ULN
9. Current or prior treatment that is known to cause a significant, ongoing change in the
course of T1D or immunologic status
10. Current or prior (within last 30 days) use of drugs other than insulin to treat
hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
11. Current use of any medication known to significantly influence glucose tolerance
(e.g., atypical antipsychotics, diphenylhydantoin, niacin)
12. Any of the following hematologic abnormalities, confirmed by repeat tests:
1. White blood count <3,000/microL or >14,000/microL
2. Lymphocyte count <500/microL
3. Platelet count <150,000 /microL
4. Hemoglobin <8.5 g/dL
5. . Neutrophil count <2,000 cells/microL.
13. Females who are pregnant, lactating, or planning on pregnancy during the 2- year study
period
14. History or diagnoses of other autoimmune diseases with the exception of stable thyroid
or celiac disease
15. History of alcohol, drug or chemical abuse within 1 year prior to study eligibility
screening evaluation
16. Any medical or psychological condition that in the opinion of the principal
investigator would interfere with safe completion of the trial
17. Prior participation in a clinical trial that could increase risks associated with this
clinical trial
18. 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 randomization
19. High lipid levels (fasting Low-density lipoprotein (LDL) cholesterol ≥160 mg/dL)
20. History of significant allergy (e.g. anaphylaxis) to milk or soy proteins.
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey
650-498-4450
I'm interested
Psoriasis Clinical Trials
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.
Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Tocilizumab (TCZ)
- drug: Placebo
- other: Standard of Care
Eligibility
Inclusion Criteria:
1. Male or female aged 6-45 years*
-*Current Institutional Review Board (IRB)-approved age eligibility criteria is
restricted to subjects 6 to 17 years of age at time of study enrollment
2. Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association
T1DM criteria, within 100 days of study enrollment
3. Positive for at least one diabetes-related autoantibody, including but not limited to:
1. Glutamate decarboxylase (GAD-65)
2. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
3. Insulinoma antigen-2 (IA-2)
4. Zinc transporter-8 (ZnT8)
4. Peak stimulated C-peptide level ≥ 0.2 pmol/mL following a mixed-meal tolerance test
(MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
(V0)
5. Signed informed consent (and informed assent of minor, if applicable).
Exclusion Criteria:
1. Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
2. History of malignancy or serious uncontrolled cardiovascular, nervous system,
pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
3. Any history of recent serious bacterial, viral, fungal, or other opportunistic
infections
4. Have serologic evidence of current or past HIV (Human immunodeficiency virus),
Hepatitis B, or Hepatitis C
5. Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
6. Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load ≥10,000
copies per mL of whole blood
7. Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥10,000
copies per mL of whole blood
8. Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine
aminotransferase (ALT), Aspartate aminotransferase (AST), or both > 1.5 x the upper
limit of age-determined normal (ULN) or total bilirubin > ULN
9. Current or prior treatment that is known to cause a significant, ongoing change in the
course of T1D or immunologic status
10. Current or prior (within last 30 days) use of drugs other than insulin to treat
hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
11. Current use of any medication known to significantly influence glucose tolerance
(e.g., atypical antipsychotics, diphenylhydantoin, niacin)
12. Any of the following hematologic abnormalities, confirmed by repeat tests:
1. White blood count <3,000/microL or >14,000/microL
2. Lymphocyte count <500/microL
3. Platelet count <150,000 /microL
4. Hemoglobin <8.5 g/dL
5. . Neutrophil count <2,000 cells/microL.
13. Females who are pregnant, lactating, or planning on pregnancy during the 2- year study
period
14. History or diagnoses of other autoimmune diseases with the exception of stable thyroid
or celiac disease
15. History of alcohol, drug or chemical abuse within 1 year prior to study eligibility
screening evaluation
16. Any medical or psychological condition that in the opinion of the principal
investigator would interfere with safe completion of the trial
17. Prior participation in a clinical trial that could increase risks associated with this
clinical trial
18. 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 randomization
19. High lipid levels (fasting Low-density lipoprotein (LDL) cholesterol ≥160 mg/dL)
20. History of significant allergy (e.g. anaphylaxis) to milk or soy proteins.
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey
650-498-4450
I'm interested
Dermatology Clinical Trials
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.
Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Tocilizumab (TCZ)
- drug: Placebo
- other: Standard of Care
Eligibility
Inclusion Criteria:
1. Male or female aged 6-45 years*
-*Current Institutional Review Board (IRB)-approved age eligibility criteria is
restricted to subjects 6 to 17 years of age at time of study enrollment
2. Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association
T1DM criteria, within 100 days of study enrollment
3. Positive for at least one diabetes-related autoantibody, including but not limited to:
1. Glutamate decarboxylase (GAD-65)
2. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
3. Insulinoma antigen-2 (IA-2)
4. Zinc transporter-8 (ZnT8)
4. Peak stimulated C-peptide level ≥ 0.2 pmol/mL following a mixed-meal tolerance test
(MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
(V0)
5. Signed informed consent (and informed assent of minor, if applicable).
Exclusion Criteria:
1. Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
2. History of malignancy or serious uncontrolled cardiovascular, nervous system,
pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
3. Any history of recent serious bacterial, viral, fungal, or other opportunistic
infections
4. Have serologic evidence of current or past HIV (Human immunodeficiency virus),
Hepatitis B, or Hepatitis C
5. Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
6. Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load ≥10,000
copies per mL of whole blood
7. Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥10,000
copies per mL of whole blood
8. Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine
aminotransferase (ALT), Aspartate aminotransferase (AST), or both > 1.5 x the upper
limit of age-determined normal (ULN) or total bilirubin > ULN
9. Current or prior treatment that is known to cause a significant, ongoing change in the
course of T1D or immunologic status
10. Current or prior (within last 30 days) use of drugs other than insulin to treat
hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
11. Current use of any medication known to significantly influence glucose tolerance
(e.g., atypical antipsychotics, diphenylhydantoin, niacin)
12. Any of the following hematologic abnormalities, confirmed by repeat tests:
1. White blood count <3,000/microL or >14,000/microL
2. Lymphocyte count <500/microL
3. Platelet count <150,000 /microL
4. Hemoglobin <8.5 g/dL
5. . Neutrophil count <2,000 cells/microL.
13. Females who are pregnant, lactating, or planning on pregnancy during the 2- year study
period
14. History or diagnoses of other autoimmune diseases with the exception of stable thyroid
or celiac disease
15. History of alcohol, drug or chemical abuse within 1 year prior to study eligibility
screening evaluation
16. Any medical or psychological condition that in the opinion of the principal
investigator would interfere with safe completion of the trial
17. Prior participation in a clinical trial that could increase risks associated with this
clinical trial
18. 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 randomization
19. High lipid levels (fasting Low-density lipoprotein (LDL) cholesterol ≥160 mg/dL)
20. History of significant allergy (e.g. anaphylaxis) to milk or soy proteins.
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey
650-498-4450
I'm interested
Pediatric Dermatology Clinical Trials
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.
Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Tocilizumab (TCZ)
- drug: Placebo
- other: Standard of Care
Eligibility
Inclusion Criteria:
1. Male or female aged 6-45 years*
-*Current Institutional Review Board (IRB)-approved age eligibility criteria is
restricted to subjects 6 to 17 years of age at time of study enrollment
2. Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association
T1DM criteria, within 100 days of study enrollment
3. Positive for at least one diabetes-related autoantibody, including but not limited to:
1. Glutamate decarboxylase (GAD-65)
2. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
3. Insulinoma antigen-2 (IA-2)
4. Zinc transporter-8 (ZnT8)
4. Peak stimulated C-peptide level ≥ 0.2 pmol/mL following a mixed-meal tolerance test
(MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
(V0)
5. Signed informed consent (and informed assent of minor, if applicable).
Exclusion Criteria:
1. Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
2. History of malignancy or serious uncontrolled cardiovascular, nervous system,
pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
3. Any history of recent serious bacterial, viral, fungal, or other opportunistic
infections
4. Have serologic evidence of current or past HIV (Human immunodeficiency virus),
Hepatitis B, or Hepatitis C
5. Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
6. Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load ≥10,000
copies per mL of whole blood
7. Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥10,000
copies per mL of whole blood
8. Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine
aminotransferase (ALT), Aspartate aminotransferase (AST), or both > 1.5 x the upper
limit of age-determined normal (ULN) or total bilirubin > ULN
9. Current or prior treatment that is known to cause a significant, ongoing change in the
course of T1D or immunologic status
10. Current or prior (within last 30 days) use of drugs other than insulin to treat
hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
11. Current use of any medication known to significantly influence glucose tolerance
(e.g., atypical antipsychotics, diphenylhydantoin, niacin)
12. Any of the following hematologic abnormalities, confirmed by repeat tests:
1. White blood count <3,000/microL or >14,000/microL
2. Lymphocyte count <500/microL
3. Platelet count <150,000 /microL
4. Hemoglobin <8.5 g/dL
5. . Neutrophil count <2,000 cells/microL.
13. Females who are pregnant, lactating, or planning on pregnancy during the 2- year study
period
14. History or diagnoses of other autoimmune diseases with the exception of stable thyroid
or celiac disease
15. History of alcohol, drug or chemical abuse within 1 year prior to study eligibility
screening evaluation
16. Any medical or psychological condition that in the opinion of the principal
investigator would interfere with safe completion of the trial
17. Prior participation in a clinical trial that could increase risks associated with this
clinical trial
18. 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 randomization
19. High lipid levels (fasting Low-density lipoprotein (LDL) cholesterol ≥160 mg/dL)
20. History of significant allergy (e.g. anaphylaxis) to milk or soy proteins.
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey
650-498-4450
I'm interested
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.
Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Tocilizumab (TCZ)
- drug: Placebo
- other: Standard of Care
Eligibility
Inclusion Criteria:
1. Male or female aged 6-45 years*
-*Current Institutional Review Board (IRB)-approved age eligibility criteria is
restricted to subjects 6 to 17 years of age at time of study enrollment
2. Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association
T1DM criteria, within 100 days of study enrollment
3. Positive for at least one diabetes-related autoantibody, including but not limited to:
1. Glutamate decarboxylase (GAD-65)
2. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
3. Insulinoma antigen-2 (IA-2)
4. Zinc transporter-8 (ZnT8)
4. Peak stimulated C-peptide level ≥ 0.2 pmol/mL following a mixed-meal tolerance test
(MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
(V0)
5. Signed informed consent (and informed assent of minor, if applicable).
Exclusion Criteria:
1. Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
2. History of malignancy or serious uncontrolled cardiovascular, nervous system,
pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
3. Any history of recent serious bacterial, viral, fungal, or other opportunistic
infections
4. Have serologic evidence of current or past HIV (Human immunodeficiency virus),
Hepatitis B, or Hepatitis C
5. Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
6. Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load ≥10,000
copies per mL of whole blood
7. Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥10,000
copies per mL of whole blood
8. Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine
aminotransferase (ALT), Aspartate aminotransferase (AST), or both > 1.5 x the upper
limit of age-determined normal (ULN) or total bilirubin > ULN
9. Current or prior treatment that is known to cause a significant, ongoing change in the
course of T1D or immunologic status
10. Current or prior (within last 30 days) use of drugs other than insulin to treat
hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
11. Current use of any medication known to significantly influence glucose tolerance
(e.g., atypical antipsychotics, diphenylhydantoin, niacin)
12. Any of the following hematologic abnormalities, confirmed by repeat tests:
1. White blood count <3,000/microL or >14,000/microL
2. Lymphocyte count <500/microL
3. Platelet count <150,000 /microL
4. Hemoglobin <8.5 g/dL
5. . Neutrophil count <2,000 cells/microL.
13. Females who are pregnant, lactating, or planning on pregnancy during the 2- year study
period
14. History or diagnoses of other autoimmune diseases with the exception of stable thyroid
or celiac disease
15. History of alcohol, drug or chemical abuse within 1 year prior to study eligibility
screening evaluation
16. Any medical or psychological condition that in the opinion of the principal
investigator would interfere with safe completion of the trial
17. Prior participation in a clinical trial that could increase risks associated with this
clinical trial
18. 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 randomization
19. High lipid levels (fasting Low-density lipoprotein (LDL) cholesterol ≥160 mg/dL)
20. History of significant allergy (e.g. anaphylaxis) to milk or soy proteins.
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey
650-498-4450
I'm interested
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.
Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Tocilizumab (TCZ)
- drug: Placebo
- other: Standard of Care
Eligibility
Inclusion Criteria:
1. Male or female aged 6-45 years*
-*Current Institutional Review Board (IRB)-approved age eligibility criteria is
restricted to subjects 6 to 17 years of age at time of study enrollment
2. Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association
T1DM criteria, within 100 days of study enrollment
3. Positive for at least one diabetes-related autoantibody, including but not limited to:
1. Glutamate decarboxylase (GAD-65)
2. Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
3. Insulinoma antigen-2 (IA-2)
4. Zinc transporter-8 (ZnT8)
4. Peak stimulated C-peptide level ≥ 0.2 pmol/mL following a mixed-meal tolerance test
(MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
(V0)
5. Signed informed consent (and informed assent of minor, if applicable).
Exclusion Criteria:
1. Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
2. History of malignancy or serious uncontrolled cardiovascular, nervous system,
pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
3. Any history of recent serious bacterial, viral, fungal, or other opportunistic
infections
4. Have serologic evidence of current or past HIV (Human immunodeficiency virus),
Hepatitis B, or Hepatitis C
5. Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
6. Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load ≥10,000
copies per mL of whole blood
7. Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥10,000
copies per mL of whole blood
8. Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine
aminotransferase (ALT), Aspartate aminotransferase (AST), or both > 1.5 x the upper
limit of age-determined normal (ULN) or total bilirubin > ULN
9. Current or prior treatment that is known to cause a significant, ongoing change in the
course of T1D or immunologic status
10. Current or prior (within last 30 days) use of drugs other than insulin to treat
hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
11. Current use of any medication known to significantly influence glucose tolerance
(e.g., atypical antipsychotics, diphenylhydantoin, niacin)
12. Any of the following hematologic abnormalities, confirmed by repeat tests:
1. White blood count <3,000/microL or >14,000/microL
2. Lymphocyte count <500/microL
3. Platelet count <150,000 /microL
4. Hemoglobin <8.5 g/dL
5. . Neutrophil count <2,000 cells/microL.
13. Females who are pregnant, lactating, or planning on pregnancy during the 2- year study
period
14. History or diagnoses of other autoimmune diseases with the exception of stable thyroid
or celiac disease
15. History of alcohol, drug or chemical abuse within 1 year prior to study eligibility
screening evaluation
16. Any medical or psychological condition that in the opinion of the principal
investigator would interfere with safe completion of the trial
17. Prior participation in a clinical trial that could increase risks associated with this
clinical trial
18. 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 randomization
19. High lipid levels (fasting Low-density lipoprotein (LDL) cholesterol ≥160 mg/dL)
20. History of significant allergy (e.g. anaphylaxis) to milk or soy proteins.
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Trudy Esrey
650-498-4450
I'm interested