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STATUS Recruitment Complete

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

LAST UPDATED

May 05 2025

Clinicaltrials.gov ID

NCT06060665

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.

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Participation Requirements

Calendar

Age

18 Years - 75 Years

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Primary Biliary Cholangitis

Gender

N/A

Date

September 2023 - June 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Seladelpar 10 mg, Placebo

Eligibility Information

Inclusion

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.
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Exclusion

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.
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Locations

Locations (45)
Other

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

Chandler, Arizona, United States, 85224

Other

California Liver Research Institute

Pasadena, California, United States, 91105

Other

University of California (UC) Davis Medical Center

Sacramento, California, United States, 95817

Other

California Pacific Medical Center

San Francisco, California, United States, 94115

Other

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

Aurora, Colorado, United States, 80045

Other

South Denver Gastroenterology

Englewood, Colorado, United States, 80113

Other

Florida Research Institute

Lakewood Ranch, Florida, United States, 34211

Other

University of Miami - Schiff Center for Liver Diseases

Miami, Florida, United States, 33136

Other

Gastro Health Research

Miami, Florida, United States, 33176

Other

Covenant Metabolic Specialists, LLC

Sarasota, Florida, United States, 33912

Other

Covenant Metabolic Specialists, LLC

Tampa, Florida, United States, 33606

Other

Digestive Healthcare of Georgia

Atlanta, Georgia, United States, 30309

Other

Northwestern Medicine Clinical Research Unit (CRU)

Chicago, Illinois, United States, 60611

Other

Tulane University Medical Center

New Orleans, Louisiana, United States, 70112

Other

Louisiana Research Center, LLC

Shreveport, Louisiana, United States, 71105

Other

Mercy Medical Center - Baltimore, Maryland

Baltimore, Maryland, United States, 21202

Other

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Other

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Other

Henry Ford Health System

Novi, Michigan, United States, 48377

Other

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Other

Kansas City Research Institute

Kansas City, Missouri, United States, 64131

Other

New-York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States, 11215

Other

Northwell Health Center for Liver Disease and Transplantation

Manhasset, New York, United States, 11030

Other

New York University (NYU) Langone Medical Center

New York, New York, United States, 10016

Other

Weill Cornell Medicine

New York, New York, United States, 10065

Other

University of Rochester Medical Center - Strong Memorial Hospital

Rochester, New York, United States, 14642

Other

Gastro Health Research

Liberty Township, Ohio, United States, 45044

Other

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

Other

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Other

UPMC Center for Liver Health

Pittsburgh, Pennsylvania, United States, 15213

Other

OGI - Gastro One

Cordova, Tennessee, United States, 38018

Other

Galen Hepatology

Hixson, Tennessee, United States, 37343

Other

Gastrointestinal Associates of Northeast Tennessee, P.C.

Johnson City, Tennessee, United States, 37604

Other

American Research Corporation - San Antonio, TX

Austin, Texas, United States, 78757

Other

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States, 75203

Other

Liver Center of Texas

Dallas, Texas, United States, 75234

Other

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Other

Soma Clinical Trials, LLC

Denison, Texas, United States, 75020

Other

Baylor College of Medicine - Baylor Clinic

Houston, Texas, United States, 77030

Other

Liver Associates of Texas, P.A.

Houston, Texas, United States, 77030

Other

Bon Secours Liver Institute of Hampton Roads

Richmond, Virginia, United States, 23226

Other

Velocity Clinical Research - Seattle

Seattle, Washington, United States, 98105

Other

Stanford University

Seattle, Washington, United States, 98195

Other

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

Montreal, Canada, H2X3J4

Other

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

Vancouver, Canada, V6Z 2K5