Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06060665
- Lead Sponsor
- CymaBay Therapeutics, Inc.
- Brief Summary
To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA).
The primary objective is to evaluate the effect of seladelpar treatment at Week 52 compared to placebo based on normalization of alkaline phosphatase (ALP) defined by a composite endpoint of ALP ≤ 1.0× upper limit of normal (ULN) and ≥ 15% decrease from baseline in PBC participants with an ALP value greater than ULN but less than 1.67× ULN.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
Individuals must meet the following criteria to be eligible for study participation:
- Male or female with a diagnosis of primary biliary cholangitis (PBC) based on history.
- Ursodeoxycholic acid (UDCA) for the 12 months prior to screening (with stable dose for > 3 months prior to screening) OR intolerant to UDCA (last dose of UDCA > 3 months prior to screening).
- ALP > 1× ULN and < 1.67× ULN.
- Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male participants 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.
Key
- Previous exposure to seladelpar (MBX-8025).
- A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study (eg, cancer) or confound its results.
- Advanced PBC as defined by the Rotterdam criteria.
- Laboratory parameters measured by the Central Laboratory at screening.
- Clinically important hepatic decompensation.
- Other chronic liver diseases.
- Known history of human immunodeficiency virus (HIV) or positive antibody test at screening.
- Clinically important alcohol consumption, defined as more than 2 drink units per day in women and 3 drink units per day in men, or inability to quantify alcohol intake reliably.
- History of malignancy diagnosed or treated, active or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening.
- History of drug abuse that would compromise the quality of the clinical study.
- Treatment with obeticholic acid or fibrates 6 weeks prior to screening.
- Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids within 2 months prior to screening.
- Initiation or dose adjustment of anti-pruritic drugs indicated for the treatment of pruritus within 1 month prior to screening.
- Immunosuppressant therapies within 6 months prior to screening.
- Other medications that affect liver or gastrointestinal functions, as well as the roux-en-y gastric bypass procedure, may be prohibited and should be discussed with the medical monitor on a case by-case basis.
- Treatment with any other investigational therapy or device within 30 days or within halflives, whichever is longer, prior to screening.
- Pregnancy or plans to become pregnant, or breastfeeding.
- Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the investigator.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Seladelpar Seladelpar 10 mg Participants will receive Seladelpar 10 mg one capsule daily for up to 52 weeks. Placebo Placebo Participants will receive placebo-to-match one capsule daily for up to 52 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Response defined as Alkaline phosphatase (ALP) ≤ 1.0× Upper Limit of Normal (ULN) AND ≥ 15% Decrease in ALP at Week 52. 52 weeks Type, Frequency, and Severity of Treatment-emergent Adverse Events. 52 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participant Response Defined as ALP ≤ 1.0× ULN. 52 weeks Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 4 Weeks. 4 weeks Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 12 Weeks. 12 weeks Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 26 Weeks. 26 weeks Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 39 Weeks. 39 weeks Absolute and Percent Change From Baseline in ALP. 52 weeks
Trial Locations
- Locations (43)
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
🇺🇸Chandler, Arizona, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
University of California (UC) Davis Medical Center
🇺🇸Sacramento, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
South Denver Gastroenterology
🇺🇸Englewood, Colorado, United States
Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
University of Miami - Schiff Center for Liver Diseases
🇺🇸Miami, Florida, United States
Gastro Health Research
🇺🇸Liberty Township, Ohio, United States
Covenant Metabolic Specialists, LLC
🇺🇸Tampa, Florida, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Northwestern Medicine Clinical Research Unit (CRU)
🇺🇸Chicago, Illinois, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Mercy Medical Center - Baltimore, Maryland
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
New-York-Presbyterian Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
Northwell Health Center for Liver Disease and Transplantation
🇺🇸Manhasset, New York, United States
New York University (NYU) Langone Medical Center
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
University of Rochester Medical Center - Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Center for Liver Health
🇺🇸Pittsburgh, Pennsylvania, United States
OGI - Gastro One
🇺🇸Cordova, Tennessee, United States
Galen Hepatology
🇺🇸Hixson, Tennessee, United States
Gastrointestinal Associates of Northeast Tennessee, P.C.
🇺🇸Johnson City, Tennessee, United States
American Research Corporation - San Antonio, TX
🇺🇸Austin, Texas, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Liver Center of Texas
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Soma Clinical Trials, LLC
🇺🇸Denison, Texas, United States
Baylor College of Medicine - Baylor Clinic
🇺🇸Houston, Texas, United States
Liver Associates of Texas, P.A.
🇺🇸Houston, Texas, United States
Bon Secours Liver Institute of Hampton Roads
🇺🇸Richmond, Virginia, United States
Velocity Clinical Research - Seattle
🇺🇸Seattle, Washington, United States
Stanford University
🇺🇸Seattle, Washington, United States
Centre de Recherche du Centre Hospitallier de I'Universite de Montreal (CRCHUM)
🇨🇦Montreal, Canada
(G.I.R.I.) GI Research Institute Foundation
🇨🇦Vancouver, Canada