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
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: fenebrutinib
- drug: teriflunomide
- drug: placebo
Eligibility
Inclusion Criteria:
- Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
- A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
- Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
- Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria:
- Disease duration of > 10 years from the onset of symptoms and an EDSS score at
screening < 2.0.
- Female participants who are pregnant or breastfeeding, or intending to become
pregnant.
- Male participants who intend to father a child during the study.
- A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS
(SPMS).
- Any known or suspected active infection at screening, including but not limited to a
positive screening tests for Hepatitis B and C, an active or latent or inadequately
treated infection with tuberculosis (TB), a confirmed or suspected progressive
multifocal leukoencephalopathy (PML).
- History of cancer including hematologic malignancy and solid tumors within 10 years of
screening.
- Known presence of other neurological disorders, that could interfere with the
diagnosis of MS or assessments of efficacy or safety during the study and clinically
significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine,
metabolic or gastrointestinal disease.
- Rare hereditary problems of galactose intolerance, total lactase deficiency, or
glucose-galactose malabsorption.
- Hypoproteinemia.
- Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
- Participants with significantly impaired bone marrow function or significant anemia,
leukopenia, neutropenia or thrombocytopenia.
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study.
- History of alcohol or other drug abuse within 12 months prior to screening.
- History of or currently active primary or secondary (non-drug-related)
immunodeficiency, including known history of human immunodeficiency virus (HIV)
infection.
- Inability to complete an MRI scan.
- Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to
screening (inhaled and topical corticosteroids are allowed).
- Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
- Any previous treatment with immunomodulatory or immunosuppressive medication without
an appropriate washout period.
OLE Inclusion Criteria:
- Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study
treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the
opinion of the investigator, may benefit from treatment with fenebrutinib.
- Participants randomized to the teriflunomide treatment arm during the DBT phase must
undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first
administration of open-label fenebrutinib.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Psoriasis Clinical Trials
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: fenebrutinib
- drug: teriflunomide
- drug: placebo
Eligibility
Inclusion Criteria:
- Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
- A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
- Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
- Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria:
- Disease duration of > 10 years from the onset of symptoms and an EDSS score at
screening < 2.0.
- Female participants who are pregnant or breastfeeding, or intending to become
pregnant.
- Male participants who intend to father a child during the study.
- A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS
(SPMS).
- Any known or suspected active infection at screening, including but not limited to a
positive screening tests for Hepatitis B and C, an active or latent or inadequately
treated infection with tuberculosis (TB), a confirmed or suspected progressive
multifocal leukoencephalopathy (PML).
- History of cancer including hematologic malignancy and solid tumors within 10 years of
screening.
- Known presence of other neurological disorders, that could interfere with the
diagnosis of MS or assessments of efficacy or safety during the study and clinically
significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine,
metabolic or gastrointestinal disease.
- Rare hereditary problems of galactose intolerance, total lactase deficiency, or
glucose-galactose malabsorption.
- Hypoproteinemia.
- Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
- Participants with significantly impaired bone marrow function or significant anemia,
leukopenia, neutropenia or thrombocytopenia.
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study.
- History of alcohol or other drug abuse within 12 months prior to screening.
- History of or currently active primary or secondary (non-drug-related)
immunodeficiency, including known history of human immunodeficiency virus (HIV)
infection.
- Inability to complete an MRI scan.
- Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to
screening (inhaled and topical corticosteroids are allowed).
- Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
- Any previous treatment with immunomodulatory or immunosuppressive medication without
an appropriate washout period.
OLE Inclusion Criteria:
- Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study
treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the
opinion of the investigator, may benefit from treatment with fenebrutinib.
- Participants randomized to the teriflunomide treatment arm during the DBT phase must
undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first
administration of open-label fenebrutinib.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Dermatology Clinical Trials
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: fenebrutinib
- drug: teriflunomide
- drug: placebo
Eligibility
Inclusion Criteria:
- Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
- A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
- Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
- Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria:
- Disease duration of > 10 years from the onset of symptoms and an EDSS score at
screening < 2.0.
- Female participants who are pregnant or breastfeeding, or intending to become
pregnant.
- Male participants who intend to father a child during the study.
- A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS
(SPMS).
- Any known or suspected active infection at screening, including but not limited to a
positive screening tests for Hepatitis B and C, an active or latent or inadequately
treated infection with tuberculosis (TB), a confirmed or suspected progressive
multifocal leukoencephalopathy (PML).
- History of cancer including hematologic malignancy and solid tumors within 10 years of
screening.
- Known presence of other neurological disorders, that could interfere with the
diagnosis of MS or assessments of efficacy or safety during the study and clinically
significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine,
metabolic or gastrointestinal disease.
- Rare hereditary problems of galactose intolerance, total lactase deficiency, or
glucose-galactose malabsorption.
- Hypoproteinemia.
- Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
- Participants with significantly impaired bone marrow function or significant anemia,
leukopenia, neutropenia or thrombocytopenia.
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study.
- History of alcohol or other drug abuse within 12 months prior to screening.
- History of or currently active primary or secondary (non-drug-related)
immunodeficiency, including known history of human immunodeficiency virus (HIV)
infection.
- Inability to complete an MRI scan.
- Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to
screening (inhaled and topical corticosteroids are allowed).
- Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
- Any previous treatment with immunomodulatory or immunosuppressive medication without
an appropriate washout period.
OLE Inclusion Criteria:
- Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study
treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the
opinion of the investigator, may benefit from treatment with fenebrutinib.
- Participants randomized to the teriflunomide treatment arm during the DBT phase must
undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first
administration of open-label fenebrutinib.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Pediatric Dermatology Clinical Trials
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: fenebrutinib
- drug: teriflunomide
- drug: placebo
Eligibility
Inclusion Criteria:
- Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
- A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
- Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
- Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria:
- Disease duration of > 10 years from the onset of symptoms and an EDSS score at
screening < 2.0.
- Female participants who are pregnant or breastfeeding, or intending to become
pregnant.
- Male participants who intend to father a child during the study.
- A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS
(SPMS).
- Any known or suspected active infection at screening, including but not limited to a
positive screening tests for Hepatitis B and C, an active or latent or inadequately
treated infection with tuberculosis (TB), a confirmed or suspected progressive
multifocal leukoencephalopathy (PML).
- History of cancer including hematologic malignancy and solid tumors within 10 years of
screening.
- Known presence of other neurological disorders, that could interfere with the
diagnosis of MS or assessments of efficacy or safety during the study and clinically
significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine,
metabolic or gastrointestinal disease.
- Rare hereditary problems of galactose intolerance, total lactase deficiency, or
glucose-galactose malabsorption.
- Hypoproteinemia.
- Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
- Participants with significantly impaired bone marrow function or significant anemia,
leukopenia, neutropenia or thrombocytopenia.
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study.
- History of alcohol or other drug abuse within 12 months prior to screening.
- History of or currently active primary or secondary (non-drug-related)
immunodeficiency, including known history of human immunodeficiency virus (HIV)
infection.
- Inability to complete an MRI scan.
- Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to
screening (inhaled and topical corticosteroids are allowed).
- Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
- Any previous treatment with immunomodulatory or immunosuppressive medication without
an appropriate washout period.
OLE Inclusion Criteria:
- Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study
treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the
opinion of the investigator, may benefit from treatment with fenebrutinib.
- Participants randomized to the teriflunomide treatment arm during the DBT phase must
undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first
administration of open-label fenebrutinib.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: fenebrutinib
- drug: teriflunomide
- drug: placebo
Eligibility
Inclusion Criteria:
- Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
- A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
- Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
- Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria:
- Disease duration of > 10 years from the onset of symptoms and an EDSS score at
screening < 2.0.
- Female participants who are pregnant or breastfeeding, or intending to become
pregnant.
- Male participants who intend to father a child during the study.
- A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS
(SPMS).
- Any known or suspected active infection at screening, including but not limited to a
positive screening tests for Hepatitis B and C, an active or latent or inadequately
treated infection with tuberculosis (TB), a confirmed or suspected progressive
multifocal leukoencephalopathy (PML).
- History of cancer including hematologic malignancy and solid tumors within 10 years of
screening.
- Known presence of other neurological disorders, that could interfere with the
diagnosis of MS or assessments of efficacy or safety during the study and clinically
significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine,
metabolic or gastrointestinal disease.
- Rare hereditary problems of galactose intolerance, total lactase deficiency, or
glucose-galactose malabsorption.
- Hypoproteinemia.
- Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
- Participants with significantly impaired bone marrow function or significant anemia,
leukopenia, neutropenia or thrombocytopenia.
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study.
- History of alcohol or other drug abuse within 12 months prior to screening.
- History of or currently active primary or secondary (non-drug-related)
immunodeficiency, including known history of human immunodeficiency virus (HIV)
infection.
- Inability to complete an MRI scan.
- Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to
screening (inhaled and topical corticosteroids are allowed).
- Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
- Any previous treatment with immunomodulatory or immunosuppressive medication without
an appropriate washout period.
OLE Inclusion Criteria:
- Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study
treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the
opinion of the investigator, may benefit from treatment with fenebrutinib.
- Participants randomized to the teriflunomide treatment arm during the DBT phase must
undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first
administration of open-label fenebrutinib.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: fenebrutinib
- drug: teriflunomide
- drug: placebo
Eligibility
Inclusion Criteria:
- Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
- A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
- Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
- Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Exclusion Criteria:
- Disease duration of > 10 years from the onset of symptoms and an EDSS score at
screening < 2.0.
- Female participants who are pregnant or breastfeeding, or intending to become
pregnant.
- Male participants who intend to father a child during the study.
- A diagnosis of primary progressive MS (PPMS) or non-active secondary progressive MS
(SPMS).
- Any known or suspected active infection at screening, including but not limited to a
positive screening tests for Hepatitis B and C, an active or latent or inadequately
treated infection with tuberculosis (TB), a confirmed or suspected progressive
multifocal leukoencephalopathy (PML).
- History of cancer including hematologic malignancy and solid tumors within 10 years of
screening.
- Known presence of other neurological disorders, that could interfere with the
diagnosis of MS or assessments of efficacy or safety during the study and clinically
significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine,
metabolic or gastrointestinal disease.
- Rare hereditary problems of galactose intolerance, total lactase deficiency, or
glucose-galactose malabsorption.
- Hypoproteinemia.
- Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome.
- Participants with significantly impaired bone marrow function or significant anemia,
leukopenia, neutropenia or thrombocytopenia.
- Any concomitant disease that may require chronic treatment with systemic
corticosteroids or immunosuppressants during the course of the study.
- History of alcohol or other drug abuse within 12 months prior to screening.
- History of or currently active primary or secondary (non-drug-related)
immunodeficiency, including known history of human immunodeficiency virus (HIV)
infection.
- Inability to complete an MRI scan.
- Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to
screening (inhaled and topical corticosteroids are allowed).
- Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
- Any previous treatment with immunomodulatory or immunosuppressive medication without
an appropriate washout period.
OLE Inclusion Criteria:
- Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study
treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the
opinion of the investigator, may benefit from treatment with fenebrutinib.
- Participants randomized to the teriflunomide treatment arm during the DBT phase must
undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first
administration of open-label fenebrutinib.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use contraceptive measures, and refrain
from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive measures, and refrain from donating sperm.
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting