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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)

Primary Purpose

Primary Biliary Cholangitis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Seladelpar 10 mg
Placebo
Sponsored by
CymaBay Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring Primary Biliary Cholangitis (PBC), PBC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must meet the following criteria to be eligible for study participation: 18 to 75 years old (inclusive) Male or female with a diagnosis of PBC based on history 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 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: 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 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 within 1 month prior to screening Immunosuppressant therapies within 6 months prior to screening 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 Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening Pregnancy or plans to become pregnant, or breastfeeding 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

Sites / Locations

  • The Institute for Liver Health II dba Arizona Liver HealthRecruiting
  • California Liver Research InstituteRecruiting
  • South Denver Gastroenterology, PCRecruiting
  • Digestive Healthcare of Georgia, P.C.Recruiting
  • Mercy Medical CenterRecruiting
  • Kansas City Research InstituteRecruiting
  • American Research CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Seladelpar 10 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects who achieve normalization of ALP (ALP ≤ ULN).

Secondary Outcome Measures

Full Information

First Posted
September 25, 2023
Last Updated
October 19, 2023
Sponsor
CymaBay Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06060665
Brief Title
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)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CymaBay Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis
Keywords
Primary Biliary Cholangitis (PBC), PBC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Seladelpar 10 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Seladelpar 10 mg
Intervention Description
Seladelpar 10 mg one capsule daily for up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One capsule daily for up to 52 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve normalization of ALP (ALP ≤ ULN).
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must meet the following criteria to be eligible for study participation: 18 to 75 years old (inclusive) Male or female with a diagnosis of PBC based on history 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 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: 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 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 within 1 month prior to screening Immunosuppressant therapies within 6 months prior to screening 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 Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening Pregnancy or plans to become pregnant, or breastfeeding 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barry Crittenden, MD
Phone
510-293-8800
Email
medinfo@cymabay.com
Facility Information:
Facility Name
The Institute for Liver Health II dba Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85524
Country
United States
Individual Site Status
Recruiting
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
South Denver Gastroenterology, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Healthcare of Georgia, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Recruiting
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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