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)

Primary Biliary Cholangitis Clinical Trial

— IDEAL  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060665
• Other study ID #: CB8025-32251
• Status: Recruiting
• Phase: Phase 3
• Start date: September 5, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: CymaBay Therapeutics, Inc.
• Contact: Barry Crittenden, MD
• Phone: 510-293-8800
• Email: medinfo[@]cymabay.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• Seladelpar 10 mg
Seladelpar 10 mg one capsule daily for up to 52 weeks
• Placebo
One capsule daily for up to 52 weeks

Locations

Country	Name	City	State
United States	Digestive Healthcare of Georgia, P.C.	Atlanta	Georgia
United States	University of Colorado Anschultz Medical Campus	Aurora	Colorado
United States	Mercy Medical Center	Baltimore	Maryland
United States	Beth Israel Deconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Institute for Liver Health II dba Arizona Liver Health	Chandler	Arizona
United States	Gastro One	Cordova	Tennessee
United States	The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas
United States	South Denver Gastroenterology, PC	Englewood	Colorado
United States	Covenant Metabolic Specialists, LLC	Fort Myers	Florida
United States	Kansas City Research Institute	Kansas City	Missouri
United States	Schiff Center for Liver Diseases/University of Miami	Miami	Florida
United States	Tulane Medical Center	New Orleans	Louisiana
United States	NYU Langone Health	New York	New York
United States	Mayview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads	Newport News	Virginia
United States	Henry Ford Columbus Center	Novi	Michigan
United States	California Liver Reasearch Institute	Pasadena	California
United States	California Liver Research Institute	Pasadena	California
United States	UPMC Center for Liver Diseases	Pittsburgh	Pennsylvania
United States	Stanford Medicine Outpatient Center	Redwood City	California
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California, Davis Medical Center	Sacramento	California
United States	University of California, Davis Medical Center (Study Visits)	Sacramento	California
United States	American Research Corporation	San Antonio	Texas
United States	California Pacific Medical Center - Sutter Pacific Medical Foundation	San Francisco	California
United States	Covenant Metabolic Specialists, LLC	Sarasota	Florida
United States	Velocity Clinical Research, Seattle (Pharmacy)	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
CymaBay Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve normalization of ALP (ALP = ULN) and = 15% decrease.		52 weeks
Primary	Type and frequency of treatment-emergent adverse events in seladelpar vs placebo treated subjects.		52 weeks