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
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: AR101 powder provided in capsules & sachets
- biological: Placebo powder provided in capsules & sachets
Eligibility
Inclusion Criteria:
- Aged 1 to < 4 years at randomization.
- Written informed consent from the legal guardian/parent (or both parents where
required by local authorities). Provide assent where required and as appropriate per
local requirements.
- Sensitivity to peanut, defined as one of the following:
- No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within
12 months before randomization.
- Documented history of physician-diagnosed IgE-mediated peanut allergy that
includes the onset of characteristic* signs and symptoms of allergy within 2
hours of known oral exposure to peanut or peanut-containing food, and has a mean
wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than
the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained
within 12 months before randomization.
- Development of age-appropriate dose-limiting allergy symptoms after consuming single
doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
- A palatable vehicle food to which the subject is not allergic must be available for
administering study product.
Exclusion Criteria:
- History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC.
- History of hemodynamically significant cardiovascular or renovascular disease,
including uncontrolled or inadequately controlled hypertension.
- History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic,
recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia
(eg, difficulty swallowing, food "getting stuck").
- Recurrent GI symptoms considered clinically significant in the opinion of the
investigator.
- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold
urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
- Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and
Blood Institute [NHLBI], 2007).
- Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to
control based on NHLBI 2007 criteria.
- History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for >
3 days) by any route of administration as defined by any of the following:
- Steroid administered daily for > 1 month within 1 year before screening
- One steroid course within 6 months before screening
- More than 2 steroid courses ≥ 1 week in duration within 1 year before screening
- History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before
screening.
- Recurrent urticaria.
- History of failure to thrive or any other form of abnormal growth, or developmental or
speech delay that precludes age-appropriate communication.
- History of chronic disease (except mild intermittent asthma, mild persistent asthma
that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at
significant risk of becoming unstable or requiring a change in a chronic therapeutic
regimen.
- Unable to discontinue antihistamines and other medications that could interfere with
the assessment of an allergic reaction for 5 half-lives of the medication before the
screening SPT, first day of dose escalation, and DBPCFCs.
- Use or anticipated use of a prohibited medication (eg, beta blockers [oral],
angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium
channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other
immunomodulatory therapy (including immunosuppressive medications).
- Treatment with any form of immunotherapy for any food allergy anytime before
screening.
- Participation in another clinical trial within 30 days or 5 half-lives of the
investigational product, whichever is longer, before screening.
- Allergy to oat or rice.
- Hypersensitivity to epinephrine or any of the excipients in the epinephrine
auto-injector.
- Parent/caregiver unable or unwilling to use epinephrine auto-injectors.
- Unable to follow the protocol requirements.
- Any other condition (concurrent disease, infection, comorbidity, or psychiatric or
psychological disorders) or reason that may interfere with the ability to participate
in the study, cause undue risk, or complicate the interpretation of data, in the
opinion of the investigator or medical monitor.
- Resides at the same place as another subject in any AR101 interventional trial.
- Lives in the same household and/or is a family member of a sponsor employee or site
staff involved in conducting this study.
Ages Eligible for Study
1 Year - 3 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
Psoriasis Clinical Trials
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: AR101 powder provided in capsules & sachets
- biological: Placebo powder provided in capsules & sachets
Eligibility
Inclusion Criteria:
- Aged 1 to < 4 years at randomization.
- Written informed consent from the legal guardian/parent (or both parents where
required by local authorities). Provide assent where required and as appropriate per
local requirements.
- Sensitivity to peanut, defined as one of the following:
- No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within
12 months before randomization.
- Documented history of physician-diagnosed IgE-mediated peanut allergy that
includes the onset of characteristic* signs and symptoms of allergy within 2
hours of known oral exposure to peanut or peanut-containing food, and has a mean
wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than
the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained
within 12 months before randomization.
- Development of age-appropriate dose-limiting allergy symptoms after consuming single
doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
- A palatable vehicle food to which the subject is not allergic must be available for
administering study product.
Exclusion Criteria:
- History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC.
- History of hemodynamically significant cardiovascular or renovascular disease,
including uncontrolled or inadequately controlled hypertension.
- History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic,
recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia
(eg, difficulty swallowing, food "getting stuck").
- Recurrent GI symptoms considered clinically significant in the opinion of the
investigator.
- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold
urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
- Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and
Blood Institute [NHLBI], 2007).
- Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to
control based on NHLBI 2007 criteria.
- History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for >
3 days) by any route of administration as defined by any of the following:
- Steroid administered daily for > 1 month within 1 year before screening
- One steroid course within 6 months before screening
- More than 2 steroid courses ≥ 1 week in duration within 1 year before screening
- History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before
screening.
- Recurrent urticaria.
- History of failure to thrive or any other form of abnormal growth, or developmental or
speech delay that precludes age-appropriate communication.
- History of chronic disease (except mild intermittent asthma, mild persistent asthma
that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at
significant risk of becoming unstable or requiring a change in a chronic therapeutic
regimen.
- Unable to discontinue antihistamines and other medications that could interfere with
the assessment of an allergic reaction for 5 half-lives of the medication before the
screening SPT, first day of dose escalation, and DBPCFCs.
- Use or anticipated use of a prohibited medication (eg, beta blockers [oral],
angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium
channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other
immunomodulatory therapy (including immunosuppressive medications).
- Treatment with any form of immunotherapy for any food allergy anytime before
screening.
- Participation in another clinical trial within 30 days or 5 half-lives of the
investigational product, whichever is longer, before screening.
- Allergy to oat or rice.
- Hypersensitivity to epinephrine or any of the excipients in the epinephrine
auto-injector.
- Parent/caregiver unable or unwilling to use epinephrine auto-injectors.
- Unable to follow the protocol requirements.
- Any other condition (concurrent disease, infection, comorbidity, or psychiatric or
psychological disorders) or reason that may interfere with the ability to participate
in the study, cause undue risk, or complicate the interpretation of data, in the
opinion of the investigator or medical monitor.
- Resides at the same place as another subject in any AR101 interventional trial.
- Lives in the same household and/or is a family member of a sponsor employee or site
staff involved in conducting this study.
Ages Eligible for Study
1 Year - 3 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
Dermatology Clinical Trials
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: AR101 powder provided in capsules & sachets
- biological: Placebo powder provided in capsules & sachets
Eligibility
Inclusion Criteria:
- Aged 1 to < 4 years at randomization.
- Written informed consent from the legal guardian/parent (or both parents where
required by local authorities). Provide assent where required and as appropriate per
local requirements.
- Sensitivity to peanut, defined as one of the following:
- No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within
12 months before randomization.
- Documented history of physician-diagnosed IgE-mediated peanut allergy that
includes the onset of characteristic* signs and symptoms of allergy within 2
hours of known oral exposure to peanut or peanut-containing food, and has a mean
wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than
the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained
within 12 months before randomization.
- Development of age-appropriate dose-limiting allergy symptoms after consuming single
doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
- A palatable vehicle food to which the subject is not allergic must be available for
administering study product.
Exclusion Criteria:
- History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC.
- History of hemodynamically significant cardiovascular or renovascular disease,
including uncontrolled or inadequately controlled hypertension.
- History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic,
recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia
(eg, difficulty swallowing, food "getting stuck").
- Recurrent GI symptoms considered clinically significant in the opinion of the
investigator.
- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold
urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
- Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and
Blood Institute [NHLBI], 2007).
- Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to
control based on NHLBI 2007 criteria.
- History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for >
3 days) by any route of administration as defined by any of the following:
- Steroid administered daily for > 1 month within 1 year before screening
- One steroid course within 6 months before screening
- More than 2 steroid courses ≥ 1 week in duration within 1 year before screening
- History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before
screening.
- Recurrent urticaria.
- History of failure to thrive or any other form of abnormal growth, or developmental or
speech delay that precludes age-appropriate communication.
- History of chronic disease (except mild intermittent asthma, mild persistent asthma
that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at
significant risk of becoming unstable or requiring a change in a chronic therapeutic
regimen.
- Unable to discontinue antihistamines and other medications that could interfere with
the assessment of an allergic reaction for 5 half-lives of the medication before the
screening SPT, first day of dose escalation, and DBPCFCs.
- Use or anticipated use of a prohibited medication (eg, beta blockers [oral],
angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium
channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other
immunomodulatory therapy (including immunosuppressive medications).
- Treatment with any form of immunotherapy for any food allergy anytime before
screening.
- Participation in another clinical trial within 30 days or 5 half-lives of the
investigational product, whichever is longer, before screening.
- Allergy to oat or rice.
- Hypersensitivity to epinephrine or any of the excipients in the epinephrine
auto-injector.
- Parent/caregiver unable or unwilling to use epinephrine auto-injectors.
- Unable to follow the protocol requirements.
- Any other condition (concurrent disease, infection, comorbidity, or psychiatric or
psychological disorders) or reason that may interfere with the ability to participate
in the study, cause undue risk, or complicate the interpretation of data, in the
opinion of the investigator or medical monitor.
- Resides at the same place as another subject in any AR101 interventional trial.
- Lives in the same household and/or is a family member of a sponsor employee or site
staff involved in conducting this study.
Ages Eligible for Study
1 Year - 3 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
Pediatric Dermatology Clinical Trials
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: AR101 powder provided in capsules & sachets
- biological: Placebo powder provided in capsules & sachets
Eligibility
Inclusion Criteria:
- Aged 1 to < 4 years at randomization.
- Written informed consent from the legal guardian/parent (or both parents where
required by local authorities). Provide assent where required and as appropriate per
local requirements.
- Sensitivity to peanut, defined as one of the following:
- No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within
12 months before randomization.
- Documented history of physician-diagnosed IgE-mediated peanut allergy that
includes the onset of characteristic* signs and symptoms of allergy within 2
hours of known oral exposure to peanut or peanut-containing food, and has a mean
wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than
the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained
within 12 months before randomization.
- Development of age-appropriate dose-limiting allergy symptoms after consuming single
doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
- A palatable vehicle food to which the subject is not allergic must be available for
administering study product.
Exclusion Criteria:
- History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC.
- History of hemodynamically significant cardiovascular or renovascular disease,
including uncontrolled or inadequately controlled hypertension.
- History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic,
recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia
(eg, difficulty swallowing, food "getting stuck").
- Recurrent GI symptoms considered clinically significant in the opinion of the
investigator.
- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold
urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
- Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and
Blood Institute [NHLBI], 2007).
- Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to
control based on NHLBI 2007 criteria.
- History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for >
3 days) by any route of administration as defined by any of the following:
- Steroid administered daily for > 1 month within 1 year before screening
- One steroid course within 6 months before screening
- More than 2 steroid courses ≥ 1 week in duration within 1 year before screening
- History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before
screening.
- Recurrent urticaria.
- History of failure to thrive or any other form of abnormal growth, or developmental or
speech delay that precludes age-appropriate communication.
- History of chronic disease (except mild intermittent asthma, mild persistent asthma
that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at
significant risk of becoming unstable or requiring a change in a chronic therapeutic
regimen.
- Unable to discontinue antihistamines and other medications that could interfere with
the assessment of an allergic reaction for 5 half-lives of the medication before the
screening SPT, first day of dose escalation, and DBPCFCs.
- Use or anticipated use of a prohibited medication (eg, beta blockers [oral],
angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium
channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other
immunomodulatory therapy (including immunosuppressive medications).
- Treatment with any form of immunotherapy for any food allergy anytime before
screening.
- Participation in another clinical trial within 30 days or 5 half-lives of the
investigational product, whichever is longer, before screening.
- Allergy to oat or rice.
- Hypersensitivity to epinephrine or any of the excipients in the epinephrine
auto-injector.
- Parent/caregiver unable or unwilling to use epinephrine auto-injectors.
- Unable to follow the protocol requirements.
- Any other condition (concurrent disease, infection, comorbidity, or psychiatric or
psychological disorders) or reason that may interfere with the ability to participate
in the study, cause undue risk, or complicate the interpretation of data, in the
opinion of the investigator or medical monitor.
- Resides at the same place as another subject in any AR101 interventional trial.
- Lives in the same household and/or is a family member of a sponsor employee or site
staff involved in conducting this study.
Ages Eligible for Study
1 Year - 3 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: AR101 powder provided in capsules & sachets
- biological: Placebo powder provided in capsules & sachets
Eligibility
Inclusion Criteria:
- Aged 1 to < 4 years at randomization.
- Written informed consent from the legal guardian/parent (or both parents where
required by local authorities). Provide assent where required and as appropriate per
local requirements.
- Sensitivity to peanut, defined as one of the following:
- No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within
12 months before randomization.
- Documented history of physician-diagnosed IgE-mediated peanut allergy that
includes the onset of characteristic* signs and symptoms of allergy within 2
hours of known oral exposure to peanut or peanut-containing food, and has a mean
wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than
the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained
within 12 months before randomization.
- Development of age-appropriate dose-limiting allergy symptoms after consuming single
doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
- A palatable vehicle food to which the subject is not allergic must be available for
administering study product.
Exclusion Criteria:
- History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC.
- History of hemodynamically significant cardiovascular or renovascular disease,
including uncontrolled or inadequately controlled hypertension.
- History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic,
recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia
(eg, difficulty swallowing, food "getting stuck").
- Recurrent GI symptoms considered clinically significant in the opinion of the
investigator.
- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold
urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
- Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and
Blood Institute [NHLBI], 2007).
- Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to
control based on NHLBI 2007 criteria.
- History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for >
3 days) by any route of administration as defined by any of the following:
- Steroid administered daily for > 1 month within 1 year before screening
- One steroid course within 6 months before screening
- More than 2 steroid courses ≥ 1 week in duration within 1 year before screening
- History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before
screening.
- Recurrent urticaria.
- History of failure to thrive or any other form of abnormal growth, or developmental or
speech delay that precludes age-appropriate communication.
- History of chronic disease (except mild intermittent asthma, mild persistent asthma
that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at
significant risk of becoming unstable or requiring a change in a chronic therapeutic
regimen.
- Unable to discontinue antihistamines and other medications that could interfere with
the assessment of an allergic reaction for 5 half-lives of the medication before the
screening SPT, first day of dose escalation, and DBPCFCs.
- Use or anticipated use of a prohibited medication (eg, beta blockers [oral],
angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium
channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other
immunomodulatory therapy (including immunosuppressive medications).
- Treatment with any form of immunotherapy for any food allergy anytime before
screening.
- Participation in another clinical trial within 30 days or 5 half-lives of the
investigational product, whichever is longer, before screening.
- Allergy to oat or rice.
- Hypersensitivity to epinephrine or any of the excipients in the epinephrine
auto-injector.
- Parent/caregiver unable or unwilling to use epinephrine auto-injectors.
- Unable to follow the protocol requirements.
- Any other condition (concurrent disease, infection, comorbidity, or psychiatric or
psychological disorders) or reason that may interfere with the ability to participate
in the study, cause undue risk, or complicate the interpretation of data, in the
opinion of the investigator or medical monitor.
- Resides at the same place as another subject in any AR101 interventional trial.
- Lives in the same household and/or is a family member of a sponsor employee or site
staff involved in conducting this study.
Ages Eligible for Study
1 Year - 3 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: AR101 powder provided in capsules & sachets
- biological: Placebo powder provided in capsules & sachets
Eligibility
Inclusion Criteria:
- Aged 1 to < 4 years at randomization.
- Written informed consent from the legal guardian/parent (or both parents where
required by local authorities). Provide assent where required and as appropriate per
local requirements.
- Sensitivity to peanut, defined as one of the following:
- No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within
12 months before randomization.
- Documented history of physician-diagnosed IgE-mediated peanut allergy that
includes the onset of characteristic* signs and symptoms of allergy within 2
hours of known oral exposure to peanut or peanut-containing food, and has a mean
wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than
the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained
within 12 months before randomization.
- Development of age-appropriate dose-limiting allergy symptoms after consuming single
doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
- A palatable vehicle food to which the subject is not allergic must be available for
administering study product.
Exclusion Criteria:
- History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC.
- History of hemodynamically significant cardiovascular or renovascular disease,
including uncontrolled or inadequately controlled hypertension.
- History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic,
recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia
(eg, difficulty swallowing, food "getting stuck").
- Recurrent GI symptoms considered clinically significant in the opinion of the
investigator.
- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold
urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
- Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and
Blood Institute [NHLBI], 2007).
- Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to
control based on NHLBI 2007 criteria.
- History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for >
3 days) by any route of administration as defined by any of the following:
- Steroid administered daily for > 1 month within 1 year before screening
- One steroid course within 6 months before screening
- More than 2 steroid courses ≥ 1 week in duration within 1 year before screening
- History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before
screening.
- Recurrent urticaria.
- History of failure to thrive or any other form of abnormal growth, or developmental or
speech delay that precludes age-appropriate communication.
- History of chronic disease (except mild intermittent asthma, mild persistent asthma
that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at
significant risk of becoming unstable or requiring a change in a chronic therapeutic
regimen.
- Unable to discontinue antihistamines and other medications that could interfere with
the assessment of an allergic reaction for 5 half-lives of the medication before the
screening SPT, first day of dose escalation, and DBPCFCs.
- Use or anticipated use of a prohibited medication (eg, beta blockers [oral],
angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium
channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other
immunomodulatory therapy (including immunosuppressive medications).
- Treatment with any form of immunotherapy for any food allergy anytime before
screening.
- Participation in another clinical trial within 30 days or 5 half-lives of the
investigational product, whichever is longer, before screening.
- Allergy to oat or rice.
- Hypersensitivity to epinephrine or any of the excipients in the epinephrine
auto-injector.
- Parent/caregiver unable or unwilling to use epinephrine auto-injectors.
- Unable to follow the protocol requirements.
- Any other condition (concurrent disease, infection, comorbidity, or psychiatric or
psychological disorders) or reason that may interfere with the ability to participate
in the study, cause undue risk, or complicate the interpretation of data, in the
opinion of the investigator or medical monitor.
- Resides at the same place as another subject in any AR101 interventional trial.
- Lives in the same household and/or is a family member of a sponsor employee or site
staff involved in conducting this study.
Ages Eligible for Study
1 Year - 3 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting