OVERVIEW
IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 Study Intended 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) (IDEAL)
PROTOCOL 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.
View moreParticipation requirements
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Age
18 years - 75 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Primary Biliary Cholangitis
Gender
N/A
Date
September 2023 - May 2026
Study Type
Interventional
Study Phase
Phase 3
Product
Seladelpar 10 mg, Placebo
Eligibility information
Inclusion criteria
- Individuals must meet the following criteria to be eligible for study participation:
- 1. Male or female with a diagnosis of primary biliary cholangitis (PBC) based on history.
- 2. 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).
- 3. ALP > 1× ULN and < 1.67× ULN.
- 4. 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.
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 (eg, cancer) or confound its results.
- 3. Advanced PBC as defined by the Rotterdam criteria.
- 4. Laboratory parameters measured by the Central Laboratory at screening.
- 5. Clinically important hepatic decompensation.
- 6. Other chronic liver diseases.
- 7. Known history of human immunodeficiency virus (HIV) or positive antibody test at screening.
- 8. 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.
- 9. 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.
- 10. History of drug abuse that would compromise the quality of the clinical study.
- 11. Treatment with obeticholic acid or fibrates 6 weeks prior to screening.
- 12. Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids within 2 months prior to screening.
- 13. Initiation or dose adjustment of anti-pruritic drugs indicated for the treatment of pruritus within 1 month prior to screening.
- 14. Immunosuppressant therapies within 6 months prior to screening.
- 15. 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.
- 16. Treatment with any other investigational therapy or device within 30 days or within halflives, whichever is longer, prior to screening.
- 17. Pregnancy or plans to become pregnant, or breastfeeding.
- 18. 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.
Locations
Locations (45)
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
Chandler, Arizona, United States, 85224
California Liver Research Institute
Pasadena, California, United States, 91105
University of California (UC) Davis Medical Center
Sacramento, California, United States, 95817
California Pacific Medical Center
San Francisco, California, United States, 94115
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
South Denver Gastroenterology
Englewood, Colorado, United States, 80113
Florida Research Institute
Lakewood Rch, Florida, United States, 34211
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
Covenant Metabolic Specialists, LLC
Sarasota, Florida, United States, 33912
Covenant Metabolic Specialists, LLC
Tampa, Florida, United States, 33606
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
Northwestern Medicine Clinical Research Unit (CRU)
Chicago, Illinois, United States, 60611
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71105
Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland, United States, 21202
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
New-York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States, 11030
New York University (NYU) Langone Medical Center
New York, New York, United States, 10016
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, New York, United States, 14642
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
UPMC Center for Liver Health
Pittsburgh, Pennsylvania, United States, 15213
Gastrointestinal Associates of Northeast Tennessee, P.C.
Johnson City, Tennessee, United States, 37604
American Research Corporation - San Antonio, TX
Austin, Texas, United States, 78757
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine - Baylor Clinic
Houston, Texas, United States, 77030
Bon Secours Liver Institute of Hampton Roads
Richmond, Virginia, United States, 23226
Velocity Clinical Research - Seattle
Seattle, Washington, United States, 98105
Centre de Recherche du Centre Hospitallier de I'Universite de Montreal (CRCHUM)
Montreal, Canada, H2X3J4
(G.I.R.I.) GI Research Institute Foundation
Vancouver, Canada, V6Z 2K5
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