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
A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: ARD-101
Eligibility
Inclusion Criteria:
- Male and female subjects, 17-65 years of age
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
participant); provide voluntary, written assent (participants, as appropriate)
- PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting
defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or
methylation studies
- BMI ≥ 18.5 kg/m²
- A HQ-CT score ≥ 10
- If a subject has a diagnosis of type 2 diabetes, the following criteria must be met:
1. Hemoglobin A1c (HbA1c) <7.5% not being managed with insulin. Patients taking
glucagon-like peptide (GLP)-1 analogues (exenatide or liraglutide) must have been
on stable dose for greater than 3 months.
2. Fasting plasma glucose <140 mg/dL during the Screening Period
3. No history of ketoacidosis or hyperosmolar coma
- Stable or well-controlled blood pressure (BP) and vital signs. Specifically: Vital
signs after 5 minutes resting in seated position (feet flat on floor, back supported):
1. 95 mmHg
2. 45 mmHg
3. 40 bpm
- Stable body weight for ~2 months (self or guardian-reported loss/gain within ± 10%)
prior to enrollment
- Standard 12-lead ECG parameters after 10 minutes resting in supine position in the
following ranges; 120 ms
be not clinically relevant.
- Parent or guardian is able to communicate well with the investigator, to understand
and comply with the requirements of the study, and be able to understand and sign the
written informed consent. Assent is to be provided for the patient who cannot consent
for himself or herself
- Results of screening clinical laboratory tests [complete blood count (CBC) with
differential and platelets and chemistry profile] and vital signs must be within
normal range or, if outside of the normal range, must be accepted by the investigator
and sponsor as not clinically significant
- Females of non-childbearing potential, defined as surgically sterile (status post
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal
for at least 12 months (and confirmed with a screening FSH level in the
post-menopausal lab range), do not require contraception during the study. This may
also apply to subjects with documented hypogonadism with and without estrogen
replacement therapy as per investigator judgement. All other females of child-bearing
potential must agree to use contraception as outlined in the protocol
- Males with female partners of childbearing potential must agree to a double barrier
method if they become sexually active during the study and for 90 days following the
study.
- Patients previously treated with ARD-101 may be re-enrolled based on investigator
decision and/if at least 3 months time has passed since the last dose.
- Patients must be on a stable dose of any allowed chronic concomitant medications while
participating in the study, as described in protocol. This is defined as no changes in
medication or dose for at least 30 days prior to Day 1 Stable concomitant usage (>3
months) of medications commonly used in PWS patients are allowed
Exclusion Criteria:
- Use of weight loss agents, including herbal medication, within 3 months prior to
enrollment
- Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other DSM-III
disorders which the investigator believes will interfere significantly with study
compliance
- A PHQ-9 score of ≥10
- Any suicidal ideation of type 4 or 5 on the C-SSRS
- Clinically significant illness in the 8 weeks prior to enrollment
- History of clinically significant bleeding disorders
- Current, clinically significant liver, renal, pulmonary, cardiac, oncologic, or
gastrointestinal (GI) disease
- Diagnosis of type 1 diabetes mellitus or other active endocrine disorders (e.g.,
Cushing syndrome, or thyroid dysfunction except if on stable adequate thyroid or
glucocorticoid replacement supplement)
- Liver disease or liver injury as indicated by abnormal liver function tests, SGOT
(aspartate aminotransferase (AST)), alkaline phosphatase, or serum bilirubin (> 1.5 x
upper limit of normal (ULN) for any of these tests) or history of hepatic cirrhosis
- History or presence of impaired renal function as indicated by clinically
significantly abnormal creatinine, blood urea nitrogen (BUN), or urinary constituents
(e.g., albuminuria) or moderate to severe renal dysfunction as defined by the Cockroft
Gault equation (< 50 mL/min)
- Significant history of abuse of drugs within 1 year prior to enrollment or a positive
Drugs of Abuse (DOA) test at screening
- History of alcohol abuse within 1 year prior to enrollment or currently drinks in
excess of 21 units per week (3 servings or units/day)
- Caffeine consumption exceeding 6 cups of caffeinated tea/coffee (or equivalent) per
day
- Participation in any clinical study with an investigational drug/device within 1 month
prior to enrollment
- Serious adverse reaction or significant hypersensitivity to any drug
- Clinically significant blood loss or blood donation > 500 mL within 3 months prior to
enrollment
- Inadequate venous access
- History of significant drug hypersensitivity or anaphylaxis
- Any condition that the investigator or primary physician believes may not be
appropriate for participating the study
Ages Eligible for Study
17 Years - 65 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Diane Stafford, MD
650-721-1811
I'm interested
Psoriasis Clinical Trials
A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: ARD-101
Eligibility
Inclusion Criteria:
- Male and female subjects, 17-65 years of age
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
participant); provide voluntary, written assent (participants, as appropriate)
- PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting
defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or
methylation studies
- BMI ≥ 18.5 kg/m²
- A HQ-CT score ≥ 10
- If a subject has a diagnosis of type 2 diabetes, the following criteria must be met:
1. Hemoglobin A1c (HbA1c) <7.5% not being managed with insulin. Patients taking
glucagon-like peptide (GLP)-1 analogues (exenatide or liraglutide) must have been
on stable dose for greater than 3 months.
2. Fasting plasma glucose <140 mg/dL during the Screening Period
3. No history of ketoacidosis or hyperosmolar coma
- Stable or well-controlled blood pressure (BP) and vital signs. Specifically: Vital
signs after 5 minutes resting in seated position (feet flat on floor, back supported):
1. 95 mmHg
2. 45 mmHg
3. 40 bpm
- Stable body weight for ~2 months (self or guardian-reported loss/gain within ± 10%)
prior to enrollment
- Standard 12-lead ECG parameters after 10 minutes resting in supine position in the
following ranges; 120 ms
be not clinically relevant.
- Parent or guardian is able to communicate well with the investigator, to understand
and comply with the requirements of the study, and be able to understand and sign the
written informed consent. Assent is to be provided for the patient who cannot consent
for himself or herself
- Results of screening clinical laboratory tests [complete blood count (CBC) with
differential and platelets and chemistry profile] and vital signs must be within
normal range or, if outside of the normal range, must be accepted by the investigator
and sponsor as not clinically significant
- Females of non-childbearing potential, defined as surgically sterile (status post
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal
for at least 12 months (and confirmed with a screening FSH level in the
post-menopausal lab range), do not require contraception during the study. This may
also apply to subjects with documented hypogonadism with and without estrogen
replacement therapy as per investigator judgement. All other females of child-bearing
potential must agree to use contraception as outlined in the protocol
- Males with female partners of childbearing potential must agree to a double barrier
method if they become sexually active during the study and for 90 days following the
study.
- Patients previously treated with ARD-101 may be re-enrolled based on investigator
decision and/if at least 3 months time has passed since the last dose.
- Patients must be on a stable dose of any allowed chronic concomitant medications while
participating in the study, as described in protocol. This is defined as no changes in
medication or dose for at least 30 days prior to Day 1 Stable concomitant usage (>3
months) of medications commonly used in PWS patients are allowed
Exclusion Criteria:
- Use of weight loss agents, including herbal medication, within 3 months prior to
enrollment
- Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other DSM-III
disorders which the investigator believes will interfere significantly with study
compliance
- A PHQ-9 score of ≥10
- Any suicidal ideation of type 4 or 5 on the C-SSRS
- Clinically significant illness in the 8 weeks prior to enrollment
- History of clinically significant bleeding disorders
- Current, clinically significant liver, renal, pulmonary, cardiac, oncologic, or
gastrointestinal (GI) disease
- Diagnosis of type 1 diabetes mellitus or other active endocrine disorders (e.g.,
Cushing syndrome, or thyroid dysfunction except if on stable adequate thyroid or
glucocorticoid replacement supplement)
- Liver disease or liver injury as indicated by abnormal liver function tests, SGOT
(aspartate aminotransferase (AST)), alkaline phosphatase, or serum bilirubin (> 1.5 x
upper limit of normal (ULN) for any of these tests) or history of hepatic cirrhosis
- History or presence of impaired renal function as indicated by clinically
significantly abnormal creatinine, blood urea nitrogen (BUN), or urinary constituents
(e.g., albuminuria) or moderate to severe renal dysfunction as defined by the Cockroft
Gault equation (< 50 mL/min)
- Significant history of abuse of drugs within 1 year prior to enrollment or a positive
Drugs of Abuse (DOA) test at screening
- History of alcohol abuse within 1 year prior to enrollment or currently drinks in
excess of 21 units per week (3 servings or units/day)
- Caffeine consumption exceeding 6 cups of caffeinated tea/coffee (or equivalent) per
day
- Participation in any clinical study with an investigational drug/device within 1 month
prior to enrollment
- Serious adverse reaction or significant hypersensitivity to any drug
- Clinically significant blood loss or blood donation > 500 mL within 3 months prior to
enrollment
- Inadequate venous access
- History of significant drug hypersensitivity or anaphylaxis
- Any condition that the investigator or primary physician believes may not be
appropriate for participating the study
Ages Eligible for Study
17 Years - 65 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Diane Stafford, MD
650-721-1811
I'm interested
Dermatology Clinical Trials
A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: ARD-101
Eligibility
Inclusion Criteria:
- Male and female subjects, 17-65 years of age
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
participant); provide voluntary, written assent (participants, as appropriate)
- PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting
defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or
methylation studies
- BMI ≥ 18.5 kg/m²
- A HQ-CT score ≥ 10
- If a subject has a diagnosis of type 2 diabetes, the following criteria must be met:
1. Hemoglobin A1c (HbA1c) <7.5% not being managed with insulin. Patients taking
glucagon-like peptide (GLP)-1 analogues (exenatide or liraglutide) must have been
on stable dose for greater than 3 months.
2. Fasting plasma glucose <140 mg/dL during the Screening Period
3. No history of ketoacidosis or hyperosmolar coma
- Stable or well-controlled blood pressure (BP) and vital signs. Specifically: Vital
signs after 5 minutes resting in seated position (feet flat on floor, back supported):
1. 95 mmHg
2. 45 mmHg
3. 40 bpm
- Stable body weight for ~2 months (self or guardian-reported loss/gain within ± 10%)
prior to enrollment
- Standard 12-lead ECG parameters after 10 minutes resting in supine position in the
following ranges; 120 ms
be not clinically relevant.
- Parent or guardian is able to communicate well with the investigator, to understand
and comply with the requirements of the study, and be able to understand and sign the
written informed consent. Assent is to be provided for the patient who cannot consent
for himself or herself
- Results of screening clinical laboratory tests [complete blood count (CBC) with
differential and platelets and chemistry profile] and vital signs must be within
normal range or, if outside of the normal range, must be accepted by the investigator
and sponsor as not clinically significant
- Females of non-childbearing potential, defined as surgically sterile (status post
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal
for at least 12 months (and confirmed with a screening FSH level in the
post-menopausal lab range), do not require contraception during the study. This may
also apply to subjects with documented hypogonadism with and without estrogen
replacement therapy as per investigator judgement. All other females of child-bearing
potential must agree to use contraception as outlined in the protocol
- Males with female partners of childbearing potential must agree to a double barrier
method if they become sexually active during the study and for 90 days following the
study.
- Patients previously treated with ARD-101 may be re-enrolled based on investigator
decision and/if at least 3 months time has passed since the last dose.
- Patients must be on a stable dose of any allowed chronic concomitant medications while
participating in the study, as described in protocol. This is defined as no changes in
medication or dose for at least 30 days prior to Day 1 Stable concomitant usage (>3
months) of medications commonly used in PWS patients are allowed
Exclusion Criteria:
- Use of weight loss agents, including herbal medication, within 3 months prior to
enrollment
- Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other DSM-III
disorders which the investigator believes will interfere significantly with study
compliance
- A PHQ-9 score of ≥10
- Any suicidal ideation of type 4 or 5 on the C-SSRS
- Clinically significant illness in the 8 weeks prior to enrollment
- History of clinically significant bleeding disorders
- Current, clinically significant liver, renal, pulmonary, cardiac, oncologic, or
gastrointestinal (GI) disease
- Diagnosis of type 1 diabetes mellitus or other active endocrine disorders (e.g.,
Cushing syndrome, or thyroid dysfunction except if on stable adequate thyroid or
glucocorticoid replacement supplement)
- Liver disease or liver injury as indicated by abnormal liver function tests, SGOT
(aspartate aminotransferase (AST)), alkaline phosphatase, or serum bilirubin (> 1.5 x
upper limit of normal (ULN) for any of these tests) or history of hepatic cirrhosis
- History or presence of impaired renal function as indicated by clinically
significantly abnormal creatinine, blood urea nitrogen (BUN), or urinary constituents
(e.g., albuminuria) or moderate to severe renal dysfunction as defined by the Cockroft
Gault equation (< 50 mL/min)
- Significant history of abuse of drugs within 1 year prior to enrollment or a positive
Drugs of Abuse (DOA) test at screening
- History of alcohol abuse within 1 year prior to enrollment or currently drinks in
excess of 21 units per week (3 servings or units/day)
- Caffeine consumption exceeding 6 cups of caffeinated tea/coffee (or equivalent) per
day
- Participation in any clinical study with an investigational drug/device within 1 month
prior to enrollment
- Serious adverse reaction or significant hypersensitivity to any drug
- Clinically significant blood loss or blood donation > 500 mL within 3 months prior to
enrollment
- Inadequate venous access
- History of significant drug hypersensitivity or anaphylaxis
- Any condition that the investigator or primary physician believes may not be
appropriate for participating the study
Ages Eligible for Study
17 Years - 65 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Diane Stafford, MD
650-721-1811
I'm interested
Pediatric Dermatology Clinical Trials
A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: ARD-101
Eligibility
Inclusion Criteria:
- Male and female subjects, 17-65 years of age
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
participant); provide voluntary, written assent (participants, as appropriate)
- PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting
defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or
methylation studies
- BMI ≥ 18.5 kg/m²
- A HQ-CT score ≥ 10
- If a subject has a diagnosis of type 2 diabetes, the following criteria must be met:
1. Hemoglobin A1c (HbA1c) <7.5% not being managed with insulin. Patients taking
glucagon-like peptide (GLP)-1 analogues (exenatide or liraglutide) must have been
on stable dose for greater than 3 months.
2. Fasting plasma glucose <140 mg/dL during the Screening Period
3. No history of ketoacidosis or hyperosmolar coma
- Stable or well-controlled blood pressure (BP) and vital signs. Specifically: Vital
signs after 5 minutes resting in seated position (feet flat on floor, back supported):
1. 95 mmHg
2. 45 mmHg
3. 40 bpm
- Stable body weight for ~2 months (self or guardian-reported loss/gain within ± 10%)
prior to enrollment
- Standard 12-lead ECG parameters after 10 minutes resting in supine position in the
following ranges; 120 ms
be not clinically relevant.
- Parent or guardian is able to communicate well with the investigator, to understand
and comply with the requirements of the study, and be able to understand and sign the
written informed consent. Assent is to be provided for the patient who cannot consent
for himself or herself
- Results of screening clinical laboratory tests [complete blood count (CBC) with
differential and platelets and chemistry profile] and vital signs must be within
normal range or, if outside of the normal range, must be accepted by the investigator
and sponsor as not clinically significant
- Females of non-childbearing potential, defined as surgically sterile (status post
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal
for at least 12 months (and confirmed with a screening FSH level in the
post-menopausal lab range), do not require contraception during the study. This may
also apply to subjects with documented hypogonadism with and without estrogen
replacement therapy as per investigator judgement. All other females of child-bearing
potential must agree to use contraception as outlined in the protocol
- Males with female partners of childbearing potential must agree to a double barrier
method if they become sexually active during the study and for 90 days following the
study.
- Patients previously treated with ARD-101 may be re-enrolled based on investigator
decision and/if at least 3 months time has passed since the last dose.
- Patients must be on a stable dose of any allowed chronic concomitant medications while
participating in the study, as described in protocol. This is defined as no changes in
medication or dose for at least 30 days prior to Day 1 Stable concomitant usage (>3
months) of medications commonly used in PWS patients are allowed
Exclusion Criteria:
- Use of weight loss agents, including herbal medication, within 3 months prior to
enrollment
- Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other DSM-III
disorders which the investigator believes will interfere significantly with study
compliance
- A PHQ-9 score of ≥10
- Any suicidal ideation of type 4 or 5 on the C-SSRS
- Clinically significant illness in the 8 weeks prior to enrollment
- History of clinically significant bleeding disorders
- Current, clinically significant liver, renal, pulmonary, cardiac, oncologic, or
gastrointestinal (GI) disease
- Diagnosis of type 1 diabetes mellitus or other active endocrine disorders (e.g.,
Cushing syndrome, or thyroid dysfunction except if on stable adequate thyroid or
glucocorticoid replacement supplement)
- Liver disease or liver injury as indicated by abnormal liver function tests, SGOT
(aspartate aminotransferase (AST)), alkaline phosphatase, or serum bilirubin (> 1.5 x
upper limit of normal (ULN) for any of these tests) or history of hepatic cirrhosis
- History or presence of impaired renal function as indicated by clinically
significantly abnormal creatinine, blood urea nitrogen (BUN), or urinary constituents
(e.g., albuminuria) or moderate to severe renal dysfunction as defined by the Cockroft
Gault equation (< 50 mL/min)
- Significant history of abuse of drugs within 1 year prior to enrollment or a positive
Drugs of Abuse (DOA) test at screening
- History of alcohol abuse within 1 year prior to enrollment or currently drinks in
excess of 21 units per week (3 servings or units/day)
- Caffeine consumption exceeding 6 cups of caffeinated tea/coffee (or equivalent) per
day
- Participation in any clinical study with an investigational drug/device within 1 month
prior to enrollment
- Serious adverse reaction or significant hypersensitivity to any drug
- Clinically significant blood loss or blood donation > 500 mL within 3 months prior to
enrollment
- Inadequate venous access
- History of significant drug hypersensitivity or anaphylaxis
- Any condition that the investigator or primary physician believes may not be
appropriate for participating the study
Ages Eligible for Study
17 Years - 65 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Diane Stafford, MD
650-721-1811
I'm interested
A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: ARD-101
Eligibility
Inclusion Criteria:
- Male and female subjects, 17-65 years of age
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
participant); provide voluntary, written assent (participants, as appropriate)
- PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting
defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or
methylation studies
- BMI ≥ 18.5 kg/m²
- A HQ-CT score ≥ 10
- If a subject has a diagnosis of type 2 diabetes, the following criteria must be met:
1. Hemoglobin A1c (HbA1c) <7.5% not being managed with insulin. Patients taking
glucagon-like peptide (GLP)-1 analogues (exenatide or liraglutide) must have been
on stable dose for greater than 3 months.
2. Fasting plasma glucose <140 mg/dL during the Screening Period
3. No history of ketoacidosis or hyperosmolar coma
- Stable or well-controlled blood pressure (BP) and vital signs. Specifically: Vital
signs after 5 minutes resting in seated position (feet flat on floor, back supported):
1. 95 mmHg
2. 45 mmHg
3. 40 bpm
- Stable body weight for ~2 months (self or guardian-reported loss/gain within ± 10%)
prior to enrollment
- Standard 12-lead ECG parameters after 10 minutes resting in supine position in the
following ranges; 120 ms
be not clinically relevant.
- Parent or guardian is able to communicate well with the investigator, to understand
and comply with the requirements of the study, and be able to understand and sign the
written informed consent. Assent is to be provided for the patient who cannot consent
for himself or herself
- Results of screening clinical laboratory tests [complete blood count (CBC) with
differential and platelets and chemistry profile] and vital signs must be within
normal range or, if outside of the normal range, must be accepted by the investigator
and sponsor as not clinically significant
- Females of non-childbearing potential, defined as surgically sterile (status post
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal
for at least 12 months (and confirmed with a screening FSH level in the
post-menopausal lab range), do not require contraception during the study. This may
also apply to subjects with documented hypogonadism with and without estrogen
replacement therapy as per investigator judgement. All other females of child-bearing
potential must agree to use contraception as outlined in the protocol
- Males with female partners of childbearing potential must agree to a double barrier
method if they become sexually active during the study and for 90 days following the
study.
- Patients previously treated with ARD-101 may be re-enrolled based on investigator
decision and/if at least 3 months time has passed since the last dose.
- Patients must be on a stable dose of any allowed chronic concomitant medications while
participating in the study, as described in protocol. This is defined as no changes in
medication or dose for at least 30 days prior to Day 1 Stable concomitant usage (>3
months) of medications commonly used in PWS patients are allowed
Exclusion Criteria:
- Use of weight loss agents, including herbal medication, within 3 months prior to
enrollment
- Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other DSM-III
disorders which the investigator believes will interfere significantly with study
compliance
- A PHQ-9 score of ≥10
- Any suicidal ideation of type 4 or 5 on the C-SSRS
- Clinically significant illness in the 8 weeks prior to enrollment
- History of clinically significant bleeding disorders
- Current, clinically significant liver, renal, pulmonary, cardiac, oncologic, or
gastrointestinal (GI) disease
- Diagnosis of type 1 diabetes mellitus or other active endocrine disorders (e.g.,
Cushing syndrome, or thyroid dysfunction except if on stable adequate thyroid or
glucocorticoid replacement supplement)
- Liver disease or liver injury as indicated by abnormal liver function tests, SGOT
(aspartate aminotransferase (AST)), alkaline phosphatase, or serum bilirubin (> 1.5 x
upper limit of normal (ULN) for any of these tests) or history of hepatic cirrhosis
- History or presence of impaired renal function as indicated by clinically
significantly abnormal creatinine, blood urea nitrogen (BUN), or urinary constituents
(e.g., albuminuria) or moderate to severe renal dysfunction as defined by the Cockroft
Gault equation (< 50 mL/min)
- Significant history of abuse of drugs within 1 year prior to enrollment or a positive
Drugs of Abuse (DOA) test at screening
- History of alcohol abuse within 1 year prior to enrollment or currently drinks in
excess of 21 units per week (3 servings or units/day)
- Caffeine consumption exceeding 6 cups of caffeinated tea/coffee (or equivalent) per
day
- Participation in any clinical study with an investigational drug/device within 1 month
prior to enrollment
- Serious adverse reaction or significant hypersensitivity to any drug
- Clinically significant blood loss or blood donation > 500 mL within 3 months prior to
enrollment
- Inadequate venous access
- History of significant drug hypersensitivity or anaphylaxis
- Any condition that the investigator or primary physician believes may not be
appropriate for participating the study
Ages Eligible for Study
17 Years - 65 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Diane Stafford, MD
650-721-1811
I'm interested
A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: ARD-101
Eligibility
Inclusion Criteria:
- Male and female subjects, 17-65 years of age
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
participant); provide voluntary, written assent (participants, as appropriate)
- PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting
defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or
methylation studies
- BMI ≥ 18.5 kg/m²
- A HQ-CT score ≥ 10
- If a subject has a diagnosis of type 2 diabetes, the following criteria must be met:
1. Hemoglobin A1c (HbA1c) <7.5% not being managed with insulin. Patients taking
glucagon-like peptide (GLP)-1 analogues (exenatide or liraglutide) must have been
on stable dose for greater than 3 months.
2. Fasting plasma glucose <140 mg/dL during the Screening Period
3. No history of ketoacidosis or hyperosmolar coma
- Stable or well-controlled blood pressure (BP) and vital signs. Specifically: Vital
signs after 5 minutes resting in seated position (feet flat on floor, back supported):
1. 95 mmHg
2. 45 mmHg
3. 40 bpm
- Stable body weight for ~2 months (self or guardian-reported loss/gain within ± 10%)
prior to enrollment
- Standard 12-lead ECG parameters after 10 minutes resting in supine position in the
following ranges; 120 ms
be not clinically relevant.
- Parent or guardian is able to communicate well with the investigator, to understand
and comply with the requirements of the study, and be able to understand and sign the
written informed consent. Assent is to be provided for the patient who cannot consent
for himself or herself
- Results of screening clinical laboratory tests [complete blood count (CBC) with
differential and platelets and chemistry profile] and vital signs must be within
normal range or, if outside of the normal range, must be accepted by the investigator
and sponsor as not clinically significant
- Females of non-childbearing potential, defined as surgically sterile (status post
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal
for at least 12 months (and confirmed with a screening FSH level in the
post-menopausal lab range), do not require contraception during the study. This may
also apply to subjects with documented hypogonadism with and without estrogen
replacement therapy as per investigator judgement. All other females of child-bearing
potential must agree to use contraception as outlined in the protocol
- Males with female partners of childbearing potential must agree to a double barrier
method if they become sexually active during the study and for 90 days following the
study.
- Patients previously treated with ARD-101 may be re-enrolled based on investigator
decision and/if at least 3 months time has passed since the last dose.
- Patients must be on a stable dose of any allowed chronic concomitant medications while
participating in the study, as described in protocol. This is defined as no changes in
medication or dose for at least 30 days prior to Day 1 Stable concomitant usage (>3
months) of medications commonly used in PWS patients are allowed
Exclusion Criteria:
- Use of weight loss agents, including herbal medication, within 3 months prior to
enrollment
- Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other DSM-III
disorders which the investigator believes will interfere significantly with study
compliance
- A PHQ-9 score of ≥10
- Any suicidal ideation of type 4 or 5 on the C-SSRS
- Clinically significant illness in the 8 weeks prior to enrollment
- History of clinically significant bleeding disorders
- Current, clinically significant liver, renal, pulmonary, cardiac, oncologic, or
gastrointestinal (GI) disease
- Diagnosis of type 1 diabetes mellitus or other active endocrine disorders (e.g.,
Cushing syndrome, or thyroid dysfunction except if on stable adequate thyroid or
glucocorticoid replacement supplement)
- Liver disease or liver injury as indicated by abnormal liver function tests, SGOT
(aspartate aminotransferase (AST)), alkaline phosphatase, or serum bilirubin (> 1.5 x
upper limit of normal (ULN) for any of these tests) or history of hepatic cirrhosis
- History or presence of impaired renal function as indicated by clinically
significantly abnormal creatinine, blood urea nitrogen (BUN), or urinary constituents
(e.g., albuminuria) or moderate to severe renal dysfunction as defined by the Cockroft
Gault equation (< 50 mL/min)
- Significant history of abuse of drugs within 1 year prior to enrollment or a positive
Drugs of Abuse (DOA) test at screening
- History of alcohol abuse within 1 year prior to enrollment or currently drinks in
excess of 21 units per week (3 servings or units/day)
- Caffeine consumption exceeding 6 cups of caffeinated tea/coffee (or equivalent) per
day
- Participation in any clinical study with an investigational drug/device within 1 month
prior to enrollment
- Serious adverse reaction or significant hypersensitivity to any drug
- Clinically significant blood loss or blood donation > 500 mL within 3 months prior to
enrollment
- Inadequate venous access
- History of significant drug hypersensitivity or anaphylaxis
- Any condition that the investigator or primary physician believes may not be
appropriate for participating the study
Ages Eligible for Study
17 Years - 65 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Diane Stafford, MD
650-721-1811
I'm interested