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

NCT06060665 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CB8025-322512024-517409-10-00
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 45

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.

Conditions

Primary Biliary Cholangitis

Keywords

Primary Biliary Cholangitis (PBC); PBC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

Seladelpar

EXPERIMENTAL

Participants will receive Seladelpar 10 mg one capsule daily for up to 52 weeks.

Drug: Seladelpar 10 mg

Placebo

EXPERIMENTAL

Participants will receive placebo-to-match one capsule daily for up to 52 weeks.

Drug: Placebo

Interventions

Seladelpar 10 mg DRUG

Administered orally

Seladelpar

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (45)

The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

University of California (UC) Davis Medical Center

Sacramento, California, 95817, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Colorado Denver - School of Medicine - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

South Denver Gastroenterology

Englewood, Colorado, 80113, United States

Location

Florida Research Institute

Lakewood Rch, Florida, 34211, United States

Location

University of Miami - Schiff Center for Liver Diseases

Miami, Florida, 33136, United States

Location

Gastro Health Research

Miami, Florida, 33176, United States

Location

Covenant Metabolic Specialists, LLC

Sarasota, Florida, 33912, United States

Location

Covenant Metabolic Specialists, LLC

Tampa, Florida, 33606, United States

Location

Digestive Healthcare of Georgia

Atlanta, Georgia, 30309, United States

Location

Northwestern Medicine Clinical Research Unit (CRU)

Chicago, Illinois, 60611, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Mercy Medical Center - Baltimore, Maryland

Baltimore, Maryland, 21202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

New-York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Northwell Health Center for Liver Disease and Transplantation

Manhasset, New York, 11030, United States

Location

New York University (NYU) Langone Medical Center

New York, New York, 10016, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

University of Rochester Medical Center - Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Gastro Health Research

Liberty Township, Ohio, 45044, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Center for Liver Health

Pittsburgh, Pennsylvania, 15213, United States

Location

OGI - Gastro One

Cordova, Tennessee, 38018, United States

Location

Galen Hepatology

Hixson, Tennessee, 37343, United States

Location

Gastrointestinal Associates of Northeast Tennessee, P.C.

Johnson City, Tennessee, 37604, United States

Location

American Research Corporation - San Antonio, TX

Austin, Texas, 78757, United States

Location

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Liver Center of Texas

Dallas, Texas, 75234, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Soma Clinical Trials, LLC

Denison, Texas, 75020, United States

Location

Baylor College of Medicine - Baylor Clinic

Houston, Texas, 77030, United States

Location

Liver Associates of Texas, P.A.

Houston, Texas, 77030, United States

Location

Bon Secours Liver Institute of Hampton Roads

Richmond, Virginia, 23226, United States

Location

Velocity Clinical Research - Seattle

Seattle, Washington, 98105, United States

Location

Stanford University

Seattle, Washington, 98195, United States

Location

Centre de Recherche du Centre Hospitallier de I'Universite de Montreal (CRCHUM)

Montreal, H2X3J4, Canada

Location

(G.I.R.I.) GI Research Institute Foundation

Vancouver, V6Z 2K5, Canada

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

seladelpar

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (43); CA (2)