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ACTIVE NOT RECRUITING

NCT06060665

PHASE3

Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-09-05

Completion Date

2026-06

Last Updated

2025-05-05

Healthy Volunteers

Conditions

Primary Biliary Cholangitis

Interventions

DRUG

Seladelpar 10 mg

Administered orally

DRUG

Placebo

Administered orally

Key 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. Key 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 (45)

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 Rch, Florida, United States

University of Miami - Schiff Center for Liver Diseases

Miami, Florida, United States

Gastro Health Research

Miami, Florida, United States

Covenant Metabolic Specialists, LLC

Sarasota, Florida, 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

Gastro Health Research

Liberty Township, Ohio, 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

Clinical Research Directory

Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (45)