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
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: seladelpar 5-10 mg
- drug: seladelpar 10 mg
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must have given written informed consent (signed and dated) and any authorizations
required by local law
2. 18 to 75 years old (inclusive)
3. Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months
- Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or
M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive
PBC-specific antinuclear antibodies
- Documented liver biopsy result consistent with PBC
4. On a stable and recommended dose of UDCA for the past twelve months OR intolerant to
UDCA (last dose of UDCA > 3 months prior to Screening)
5. AP ≥ 1.67 × ULN
6. Females of reproductive potential must use at least one barrier contraceptive and a
second effective birth control method during the study and for at least 90 days after
the last dose. Male subjects who are sexually active with female partners of
reproductive potential must use barrier contraception and their female partners must
use a second effective birth control method during the study and for at least 90 days
after the last dose
Exclusion Criteria:
1. Previous exposure to seladelpar (MBX-8025)
2. A medical condition, other than PBC, that in the investigator's opinion would preclude
full participation in the study or confound its results (e.g., cancer)
3. AST above 3 × ULN
4. ALT above 3 × ULN
5. Total bilirubin above 2.0 × ULN
6. Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total
bilirubin above 1 × ULN)
7. Creatine kinase (CK) above 1.0 × ULN
8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
9. International normalized ratio (INR) above 1.0 × ULN
10. Platelet count below 100 × 103/µL
11. Presence of clinically significant hepatic decompensation, including:
- History of liver transplantation, current placement on liver transplantation
list, or current MELD score ≥ 15
- Complications of portal hypertension, including known esophageal varices, history
of variceal bleeds or related interventions (e.g., transjugular intrahepatic
portosystemic shunt placement), relevant ascites, hepatic encephalopathy
- Cirrhosis with complications, including history or presence of spontaneous
bacterial peritonitis
12. Other chronic liver diseases:
- Current features of auto-immune hepatitis as determined by the investigator based
on immunoserology, liver biochemistry and histology
- Primary sclerosing cholangitis determined by presence of diagnostic
cholangiographic findings
- History or clinical evidence of alcoholic liver disease
- History or clinical evidence of alpha-1-antitrypsin deficiency
- Biopsy confirmed nonalcoholic steatohepatitis
- History or evidence of Gilbert' Syndrome with elevated total bilirubin
- History or evidence of hemochromatosis
- Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C defined as presence of HCV RNA
13. Known history of HIV
14. Evidence of significant alcohol consumption
15. Evidence of drug abuse
16. Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA
must be discontinued 30 days prior to Screening
17. Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids
(> 2 weeks) within two months prior to Screening
18. Use of fibrates within 30 days prior to Screening
19. Use of simvastatin within 7 days prior to Screening
20. Use of an experimental or unapproved treatment for PBC within 30 days prior to
Screening
21. Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
22. Treatment with any other investigational therapy or device within 30 days or within
five half-lives, whatever is longer, prior to Screening
23. For females, pregnancy or breast-feeding
24. Any other condition(s) that would compromise the safety of the subject or compromise
the quality of the clinical study, as judged by the investigator
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-721-4326
I'm interested
Psoriasis Clinical Trials
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: seladelpar 5-10 mg
- drug: seladelpar 10 mg
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must have given written informed consent (signed and dated) and any authorizations
required by local law
2. 18 to 75 years old (inclusive)
3. Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months
- Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or
M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive
PBC-specific antinuclear antibodies
- Documented liver biopsy result consistent with PBC
4. On a stable and recommended dose of UDCA for the past twelve months OR intolerant to
UDCA (last dose of UDCA > 3 months prior to Screening)
5. AP ≥ 1.67 × ULN
6. Females of reproductive potential must use at least one barrier contraceptive and a
second effective birth control method during the study and for at least 90 days after
the last dose. Male subjects who are sexually active with female partners of
reproductive potential must use barrier contraception and their female partners must
use a second effective birth control method during the study and for at least 90 days
after the last dose
Exclusion Criteria:
1. Previous exposure to seladelpar (MBX-8025)
2. A medical condition, other than PBC, that in the investigator's opinion would preclude
full participation in the study or confound its results (e.g., cancer)
3. AST above 3 × ULN
4. ALT above 3 × ULN
5. Total bilirubin above 2.0 × ULN
6. Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total
bilirubin above 1 × ULN)
7. Creatine kinase (CK) above 1.0 × ULN
8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
9. International normalized ratio (INR) above 1.0 × ULN
10. Platelet count below 100 × 103/µL
11. Presence of clinically significant hepatic decompensation, including:
- History of liver transplantation, current placement on liver transplantation
list, or current MELD score ≥ 15
- Complications of portal hypertension, including known esophageal varices, history
of variceal bleeds or related interventions (e.g., transjugular intrahepatic
portosystemic shunt placement), relevant ascites, hepatic encephalopathy
- Cirrhosis with complications, including history or presence of spontaneous
bacterial peritonitis
12. Other chronic liver diseases:
- Current features of auto-immune hepatitis as determined by the investigator based
on immunoserology, liver biochemistry and histology
- Primary sclerosing cholangitis determined by presence of diagnostic
cholangiographic findings
- History or clinical evidence of alcoholic liver disease
- History or clinical evidence of alpha-1-antitrypsin deficiency
- Biopsy confirmed nonalcoholic steatohepatitis
- History or evidence of Gilbert' Syndrome with elevated total bilirubin
- History or evidence of hemochromatosis
- Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C defined as presence of HCV RNA
13. Known history of HIV
14. Evidence of significant alcohol consumption
15. Evidence of drug abuse
16. Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA
must be discontinued 30 days prior to Screening
17. Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids
(> 2 weeks) within two months prior to Screening
18. Use of fibrates within 30 days prior to Screening
19. Use of simvastatin within 7 days prior to Screening
20. Use of an experimental or unapproved treatment for PBC within 30 days prior to
Screening
21. Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
22. Treatment with any other investigational therapy or device within 30 days or within
five half-lives, whatever is longer, prior to Screening
23. For females, pregnancy or breast-feeding
24. Any other condition(s) that would compromise the safety of the subject or compromise
the quality of the clinical study, as judged by the investigator
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-721-4326
I'm interested
Dermatology Clinical Trials
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: seladelpar 5-10 mg
- drug: seladelpar 10 mg
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must have given written informed consent (signed and dated) and any authorizations
required by local law
2. 18 to 75 years old (inclusive)
3. Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months
- Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or
M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive
PBC-specific antinuclear antibodies
- Documented liver biopsy result consistent with PBC
4. On a stable and recommended dose of UDCA for the past twelve months OR intolerant to
UDCA (last dose of UDCA > 3 months prior to Screening)
5. AP ≥ 1.67 × ULN
6. Females of reproductive potential must use at least one barrier contraceptive and a
second effective birth control method during the study and for at least 90 days after
the last dose. Male subjects who are sexually active with female partners of
reproductive potential must use barrier contraception and their female partners must
use a second effective birth control method during the study and for at least 90 days
after the last dose
Exclusion Criteria:
1. Previous exposure to seladelpar (MBX-8025)
2. A medical condition, other than PBC, that in the investigator's opinion would preclude
full participation in the study or confound its results (e.g., cancer)
3. AST above 3 × ULN
4. ALT above 3 × ULN
5. Total bilirubin above 2.0 × ULN
6. Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total
bilirubin above 1 × ULN)
7. Creatine kinase (CK) above 1.0 × ULN
8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
9. International normalized ratio (INR) above 1.0 × ULN
10. Platelet count below 100 × 103/µL
11. Presence of clinically significant hepatic decompensation, including:
- History of liver transplantation, current placement on liver transplantation
list, or current MELD score ≥ 15
- Complications of portal hypertension, including known esophageal varices, history
of variceal bleeds or related interventions (e.g., transjugular intrahepatic
portosystemic shunt placement), relevant ascites, hepatic encephalopathy
- Cirrhosis with complications, including history or presence of spontaneous
bacterial peritonitis
12. Other chronic liver diseases:
- Current features of auto-immune hepatitis as determined by the investigator based
on immunoserology, liver biochemistry and histology
- Primary sclerosing cholangitis determined by presence of diagnostic
cholangiographic findings
- History or clinical evidence of alcoholic liver disease
- History or clinical evidence of alpha-1-antitrypsin deficiency
- Biopsy confirmed nonalcoholic steatohepatitis
- History or evidence of Gilbert' Syndrome with elevated total bilirubin
- History or evidence of hemochromatosis
- Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C defined as presence of HCV RNA
13. Known history of HIV
14. Evidence of significant alcohol consumption
15. Evidence of drug abuse
16. Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA
must be discontinued 30 days prior to Screening
17. Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids
(> 2 weeks) within two months prior to Screening
18. Use of fibrates within 30 days prior to Screening
19. Use of simvastatin within 7 days prior to Screening
20. Use of an experimental or unapproved treatment for PBC within 30 days prior to
Screening
21. Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
22. Treatment with any other investigational therapy or device within 30 days or within
five half-lives, whatever is longer, prior to Screening
23. For females, pregnancy or breast-feeding
24. Any other condition(s) that would compromise the safety of the subject or compromise
the quality of the clinical study, as judged by the investigator
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-721-4326
I'm interested
Pediatric Dermatology Clinical Trials
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: seladelpar 5-10 mg
- drug: seladelpar 10 mg
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must have given written informed consent (signed and dated) and any authorizations
required by local law
2. 18 to 75 years old (inclusive)
3. Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months
- Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or
M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive
PBC-specific antinuclear antibodies
- Documented liver biopsy result consistent with PBC
4. On a stable and recommended dose of UDCA for the past twelve months OR intolerant to
UDCA (last dose of UDCA > 3 months prior to Screening)
5. AP ≥ 1.67 × ULN
6. Females of reproductive potential must use at least one barrier contraceptive and a
second effective birth control method during the study and for at least 90 days after
the last dose. Male subjects who are sexually active with female partners of
reproductive potential must use barrier contraception and their female partners must
use a second effective birth control method during the study and for at least 90 days
after the last dose
Exclusion Criteria:
1. Previous exposure to seladelpar (MBX-8025)
2. A medical condition, other than PBC, that in the investigator's opinion would preclude
full participation in the study or confound its results (e.g., cancer)
3. AST above 3 × ULN
4. ALT above 3 × ULN
5. Total bilirubin above 2.0 × ULN
6. Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total
bilirubin above 1 × ULN)
7. Creatine kinase (CK) above 1.0 × ULN
8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
9. International normalized ratio (INR) above 1.0 × ULN
10. Platelet count below 100 × 103/µL
11. Presence of clinically significant hepatic decompensation, including:
- History of liver transplantation, current placement on liver transplantation
list, or current MELD score ≥ 15
- Complications of portal hypertension, including known esophageal varices, history
of variceal bleeds or related interventions (e.g., transjugular intrahepatic
portosystemic shunt placement), relevant ascites, hepatic encephalopathy
- Cirrhosis with complications, including history or presence of spontaneous
bacterial peritonitis
12. Other chronic liver diseases:
- Current features of auto-immune hepatitis as determined by the investigator based
on immunoserology, liver biochemistry and histology
- Primary sclerosing cholangitis determined by presence of diagnostic
cholangiographic findings
- History or clinical evidence of alcoholic liver disease
- History or clinical evidence of alpha-1-antitrypsin deficiency
- Biopsy confirmed nonalcoholic steatohepatitis
- History or evidence of Gilbert' Syndrome with elevated total bilirubin
- History or evidence of hemochromatosis
- Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C defined as presence of HCV RNA
13. Known history of HIV
14. Evidence of significant alcohol consumption
15. Evidence of drug abuse
16. Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA
must be discontinued 30 days prior to Screening
17. Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids
(> 2 weeks) within two months prior to Screening
18. Use of fibrates within 30 days prior to Screening
19. Use of simvastatin within 7 days prior to Screening
20. Use of an experimental or unapproved treatment for PBC within 30 days prior to
Screening
21. Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
22. Treatment with any other investigational therapy or device within 30 days or within
five half-lives, whatever is longer, prior to Screening
23. For females, pregnancy or breast-feeding
24. Any other condition(s) that would compromise the safety of the subject or compromise
the quality of the clinical study, as judged by the investigator
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-721-4326
I'm interested
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: seladelpar 5-10 mg
- drug: seladelpar 10 mg
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must have given written informed consent (signed and dated) and any authorizations
required by local law
2. 18 to 75 years old (inclusive)
3. Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months
- Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or
M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive
PBC-specific antinuclear antibodies
- Documented liver biopsy result consistent with PBC
4. On a stable and recommended dose of UDCA for the past twelve months OR intolerant to
UDCA (last dose of UDCA > 3 months prior to Screening)
5. AP ≥ 1.67 × ULN
6. Females of reproductive potential must use at least one barrier contraceptive and a
second effective birth control method during the study and for at least 90 days after
the last dose. Male subjects who are sexually active with female partners of
reproductive potential must use barrier contraception and their female partners must
use a second effective birth control method during the study and for at least 90 days
after the last dose
Exclusion Criteria:
1. Previous exposure to seladelpar (MBX-8025)
2. A medical condition, other than PBC, that in the investigator's opinion would preclude
full participation in the study or confound its results (e.g., cancer)
3. AST above 3 × ULN
4. ALT above 3 × ULN
5. Total bilirubin above 2.0 × ULN
6. Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total
bilirubin above 1 × ULN)
7. Creatine kinase (CK) above 1.0 × ULN
8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
9. International normalized ratio (INR) above 1.0 × ULN
10. Platelet count below 100 × 103/µL
11. Presence of clinically significant hepatic decompensation, including:
- History of liver transplantation, current placement on liver transplantation
list, or current MELD score ≥ 15
- Complications of portal hypertension, including known esophageal varices, history
of variceal bleeds or related interventions (e.g., transjugular intrahepatic
portosystemic shunt placement), relevant ascites, hepatic encephalopathy
- Cirrhosis with complications, including history or presence of spontaneous
bacterial peritonitis
12. Other chronic liver diseases:
- Current features of auto-immune hepatitis as determined by the investigator based
on immunoserology, liver biochemistry and histology
- Primary sclerosing cholangitis determined by presence of diagnostic
cholangiographic findings
- History or clinical evidence of alcoholic liver disease
- History or clinical evidence of alpha-1-antitrypsin deficiency
- Biopsy confirmed nonalcoholic steatohepatitis
- History or evidence of Gilbert' Syndrome with elevated total bilirubin
- History or evidence of hemochromatosis
- Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C defined as presence of HCV RNA
13. Known history of HIV
14. Evidence of significant alcohol consumption
15. Evidence of drug abuse
16. Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA
must be discontinued 30 days prior to Screening
17. Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids
(> 2 weeks) within two months prior to Screening
18. Use of fibrates within 30 days prior to Screening
19. Use of simvastatin within 7 days prior to Screening
20. Use of an experimental or unapproved treatment for PBC within 30 days prior to
Screening
21. Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
22. Treatment with any other investigational therapy or device within 30 days or within
five half-lives, whatever is longer, prior to Screening
23. For females, pregnancy or breast-feeding
24. Any other condition(s) that would compromise the safety of the subject or compromise
the quality of the clinical study, as judged by the investigator
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-721-4326
I'm interested
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: seladelpar 5-10 mg
- drug: seladelpar 10 mg
- drug: Placebo
Eligibility
Inclusion Criteria:
1. Must have given written informed consent (signed and dated) and any authorizations
required by local law
2. 18 to 75 years old (inclusive)
3. Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months
- Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or
M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive
PBC-specific antinuclear antibodies
- Documented liver biopsy result consistent with PBC
4. On a stable and recommended dose of UDCA for the past twelve months OR intolerant to
UDCA (last dose of UDCA > 3 months prior to Screening)
5. AP ≥ 1.67 × ULN
6. Females of reproductive potential must use at least one barrier contraceptive and a
second effective birth control method during the study and for at least 90 days after
the last dose. Male subjects who are sexually active with female partners of
reproductive potential must use barrier contraception and their female partners must
use a second effective birth control method during the study and for at least 90 days
after the last dose
Exclusion Criteria:
1. Previous exposure to seladelpar (MBX-8025)
2. A medical condition, other than PBC, that in the investigator's opinion would preclude
full participation in the study or confound its results (e.g., cancer)
3. AST above 3 × ULN
4. ALT above 3 × ULN
5. Total bilirubin above 2.0 × ULN
6. Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total
bilirubin above 1 × ULN)
7. Creatine kinase (CK) above 1.0 × ULN
8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
9. International normalized ratio (INR) above 1.0 × ULN
10. Platelet count below 100 × 103/µL
11. Presence of clinically significant hepatic decompensation, including:
- History of liver transplantation, current placement on liver transplantation
list, or current MELD score ≥ 15
- Complications of portal hypertension, including known esophageal varices, history
of variceal bleeds or related interventions (e.g., transjugular intrahepatic
portosystemic shunt placement), relevant ascites, hepatic encephalopathy
- Cirrhosis with complications, including history or presence of spontaneous
bacterial peritonitis
12. Other chronic liver diseases:
- Current features of auto-immune hepatitis as determined by the investigator based
on immunoserology, liver biochemistry and histology
- Primary sclerosing cholangitis determined by presence of diagnostic
cholangiographic findings
- History or clinical evidence of alcoholic liver disease
- History or clinical evidence of alpha-1-antitrypsin deficiency
- Biopsy confirmed nonalcoholic steatohepatitis
- History or evidence of Gilbert' Syndrome with elevated total bilirubin
- History or evidence of hemochromatosis
- Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C defined as presence of HCV RNA
13. Known history of HIV
14. Evidence of significant alcohol consumption
15. Evidence of drug abuse
16. Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA
must be discontinued 30 days prior to Screening
17. Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids
(> 2 weeks) within two months prior to Screening
18. Use of fibrates within 30 days prior to Screening
19. Use of simvastatin within 7 days prior to Screening
20. Use of an experimental or unapproved treatment for PBC within 30 days prior to
Screening
21. Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
22. Treatment with any other investigational therapy or device within 30 days or within
five half-lives, whatever is longer, prior to Screening
23. For females, pregnancy or breast-feeding
24. Any other condition(s) that would compromise the safety of the subject or compromise
the quality of the clinical study, as judged by the investigator
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-721-4326
I'm interested