ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/5/2019
Start Date:November 26, 2018
End Date:December 2021
Contact:Pol F Boudes, MD
Email:PBoudes@cymabay.com
Phone:510-293-8815

Use our guide to learn which trials are right for you!

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 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)

Primary:

• To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day
titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placebo

Key Secondary:

- To evaluate the effect of seladelpar on normalization of alkaline phosphatase (AP)
levels

- To evaluate the effect of seladelpar on pruritus

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
We found this trial at
38
sites
New York, New York 10016
Principal Investigator: Hillel Tobias, MD
Phone: 212-726-9472
?
mi
from
New York, NY
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Daniel Pratt, MD
Phone: 617-726-0161
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Alan Bonder, MD
Phone: 617-632-1086
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: John M Vierling, MD
Phone: 713-798-5242
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Michael Porayko, MD
Phone: 415-600-1627
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Jonathan C Huang, DO
Phone: 585-275-4711
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Asheville, North Carolina 28801
Principal Investigator: Adam S Zivony, MD
Phone: 828-254-0881
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia 30309
Principal Investigator: Michael R Galambos, MD
Phone: 678-686-5073
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Lisa Forman, MD
Phone: 303-724-1866
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18017
Principal Investigator: Adam Peyton, DO
Phone: 610-433-4100
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Boca Raton, Florida 33434
Principal Investigator: Seth J Baum, MD
Phone: 561-756-8206
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
1955 West Frye Road
Chandler, Arizona 85224
Principal Investigator: Anita Kohli, MD
Phone: 480-686-8874
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Gautham Reddy, MD
Phone: 773-702-2001
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Dallas, Texas 75203
Principal Investigator: Mangesh Pagadala, MD
Phone: 214-947-4452
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Fort Worth, Texas 76104
Principal Investigator: Apurva A Modi, MD
Phone: 817-310-4478
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Germantown, Tennessee 38138
Principal Investigator: Ziad Younes, MD
Phone: 901-682-6540
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Herston, Queensland
Principal Investigator: Barbara Leggett, MD
Phone: ??61 736 461757
?
mi
from
Herston,
Click here to add this to my saved trials
Indianapolis, Indiana 46237
Principal Investigator: David C Pound, MD
Phone: 317-865-2959
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jackson, Mississippi 39216
Principal Investigator: Brian B Borg, MD
Phone: 769-251-5674
?
mi
from
Jackson, MS
Click here to add this to my saved trials
425 Volker Boulevard
Kansas City, Missouri 64131
Principal Investigator: Bradley L Freilich, MD
Phone: 816-759-5274
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37909
Principal Investigator: Jason Huffman, MD
Phone: 865-558-0687
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lakewood Ranch, Florida 34211
Principal Investigator: Guy W Neff, MD
Phone: 941-727-7772
?
mi
from
Lakewood Ranch, FL
Click here to add this to my saved trials
Maplewood, Minnesota 55117
Principal Investigator: Donald L Zogg, MD
Phone: 612-870-5597
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
Miami, Florida 33136
Principal Investigator: Cynthia Levy, MD
Phone: 305-243-1501
?
mi
from
Miami, FL
Click here to add this to my saved trials
2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
Principal Investigator: John Lake, MD
Phone: 612-625-2695
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New Haven, Connecticut 06510
Principal Investigator: Marina Silveira, MD
Phone: 203-737-6839
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70112
Principal Investigator: Martin Moehlen, MD
Phone: 504-988-3048
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
462 1st Avenue
New York, New York 10010
Principal Investigator: Carmen Stanca, MD
Phone: 646-501-8468
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York
Principal Investigator: Elizabeth Verna, MD
Phone: 212-305-3839
?
mi
from
New York, NY
Click here to add this to my saved trials
Novi, Michigan 48377
Principal Investigator: Stuart Gordon, MD
Phone: 248-344-2350
?
mi
from
Novi, MI
Click here to add this to my saved trials
Redwood City, California 94063
Principal Investigator: Aparna Goel, MD
Phone: 650-721-4326
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
Richmond, Virginia 23226
Principal Investigator: Mitchell L Shiffman, MD
Phone: 804-977-8921
?
mi
from
Richmond, VA
Click here to add this to my saved trials
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Christopher Bowlus, MD
Phone: 916-734-8985
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas 78215
Principal Investigator: Eric J Lawitz, MD
Phone: 210-253-3426
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78265
Principal Investigator: Stephen Harrison, MD
Phone: 210-982-0320
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Kidst Yimam, MD
Phone: 415-600-1627
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Kris Kowdely, MD
Phone: 206-215-2126
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tupelo, Mississippi 38801
Principal Investigator: John Phillips, MD
Phone: 662-377-4630
?
mi
from
Tupelo, MS
Click here to add this to my saved trials