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STATUS Recruiting

IDEAL: 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)

LAST UPDATED

November 22 2024

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)

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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 - December 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Seladelpar 10 mg, Placebo

Eligibility Information

Inclusion

Inclusion Criteria

  • Subjects must meet the following criteria to be eligible for study participation:
  • 1. 18 to 75 years old (inclusive)
  • 2. Male or female with a diagnosis of PBC based on history
  • 3. 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)
  • 4. ALP >1×ULN and <1.67×ULN
  • 5. 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 subjects 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

  • Subjects must not meet any of the following criteria to be eligible for study participation:
  • 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
  • 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 within 1 month prior to screening
  • 14. Immunosuppressant therapies within 6 months prior to screening
  • 15. Other medications that affect liver or GI 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 5 half-lives, 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 subject or compromise the quality of the clinical study, as judged by the Investigator
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Locations

Locations (35)
Recruitment Complete

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

Chandler, Arizona, United States, 85224

Recruiting

California Liver Research Institute

Pasadena, California, United States, 91105

Recruiting

University of California (UC) Davis Medical Center

Sacramento, California, United States, 95817

Recruiting

California Pacific Medical Center

San Francisco, California, United States, 94115

Recruiting

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

Aurora, Colorado, United States, 80045

Recruiting

South Denver Gastroenterology

Englewood, Colorado, United States, 80113

Will Be Recruiting

Florida Research Institute

Lakewood Ranch, Florida, United States, 34211

Recruitment Complete

University of Miami - Schiff Center for Liver Diseases

Miami, Florida, United States, 33136

Recruiting

Covenant Metabolic Specialists, LLC

Sarasota, Florida, United States, 33912

Recruitment Complete

Covenant Metabolic Specialists, LLC

Tampa, Florida, United States, 33606

Recruiting

Digestive Healthcare of Georgia

Atlanta, Georgia, United States, 30309

Recruiting

Tulane University Medical Center

New Orleans, Louisiana, United States, 70112

Recruitment Complete

Louisiana Research Center, LLC

Shreveport, Louisiana, United States, 71105

Recruiting

Mercy Medical Center - Baltimore, Maryland

Baltimore, Maryland, United States, 21202

Recruiting

OGI - Gastro One

Germantown, Maryland, United States, 38138

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Recruitment Complete

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Recruitment Complete

Henry Ford Health System

Novi, Michigan, United States, 48377

Will Be Recruiting

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Recruitment Complete

Kansas City Research Institute

Kansas City, Missouri, United States, 64131

Recruiting

New-York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States, 11215

Recruiting

Northwell Health Center for Liver Disease and Transplantation

Manhasset, New York, United States, 11030

Recruiting

New York University (NYU) Langone Medical Center

New York, New York, United States, 10016

Will Be Recruiting

Weill Cornell Medicine

New York, New York, United States, 10065

Recruitment Complete

University of Rochester Medical Center - Strong Memorial Hospital

Rochester, New York, United States, 14642

Recruiting

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

Recruiting

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Recruiting

UPMC Center for Liver Health

Pittsburgh, Pennsylvania, United States, 15213

Recruiting

Galen Hepatology

Hixson, Tennessee, United States, 37343

Recruiting

American Research Corporation - San Antonio, TX

Austin, Texas, United States, 78757

Recruiting

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States, 75203

Recruiting

Liver Associates of Texas, P.A.

Houston, Texas, United States, 77030

Recruiting

Bon Secours Liver Institute of Hampton Roads

Richmond, Virginia, United States, 23226

Recruiting

Velocity Clinical Research - Seattle

Seattle, Washington, United States, 98105

Recruitment Complete

Stanford University

Seattle, Washington, United States, 98195