Trial Summary
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)
Status
Recruiting
Condition
Primary Biliary Cholangitis
Actual Start Date
September 05, 2023
Estimated Primary Completion Date
December 2025
About the Trial
The IDEAL trial is designed to evaluate the potential benefit of seladelpar in a population that has a persistent elevation of ALP, but whose ALP levels are not above the 1.67 times upper-limit-of-normal that are typically used for entering clinical trials of new second-line investigational drugs.The IDEAL trial aims to enroll 150 patients with PBC who have an incomplete response or intolerance to ursodeoxycholic acid (UDCA), in each case with ALP greater than the upper limit of normal (ULN) but less than 1.67xULN, and total bilirubin less than or equal to 2xULN. Patients will be randomly assigned using a 2:1 ratio to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the normalization of ALP at 52 weeks. Hence, the IDEAL trial is an opportunity to study this additional PBC patient population with unmet need.
Detailed Info
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)
ClinicalTrials.gov ID
NCT06060665
Study Phase
Phase 3
Estimated Enrollment
150
Estimated Primary Completion Date
December 2025
Study Type
Interventional
Interventions
- DRUG: Seladelpar 10 mg
- Seladelpar 10 mg one capsule daily for up to 52 weeks
- DRUG: Placebo
- One capsule daily for up to 52 weeks
Sponsor
CymaBay Therapeutics, Inc.
Eligibility
Inclusion Criteria
Qualities or factors you must have to be included in the trial. The trial site may advise you on additional factors.
Gender
Male or female with a diagnosis of PBC based on history
Age
18 to 75 years old (inclusive)
- 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
Qualities or factors that would not allow you to participate in the trial. The trial site may advise you on additional factors.
- 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
Locations
The following cities have Seladelpar clinical trial sites. Please check back often as locations will be updated.
Enrollment
For more information on enrollment into our current clinical trials, please contact us or visit clinicaltrials.gov for location information.
About Primary Biliary Cholangitis (PBC)?
PBC is a rare, chronic, autoimmune liver disease that progressively destroys the liver’s bile ducts.
Read More About PBCFrequently Asked Questions
What is a clinical trial?
A Clinical Trial is a type of research study that examines how well a potential therapy works in humans.
Why is this trial being done?
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)
How do I know if I can participate in this trial?
This clinical trial has certain criteria that a person has to meet to determine if they can participate. After you have discussed the trial with your doctor, specific tests will be done to see if you qualify for this study.
Who is sponsoring this trial?
CymaBay Therapeutics, Inc. is sponsoring this clinical trial.
How many people will participate in this trial?
There will be a total of 75 patients enrolled in this clinical trial.
Where do I go to participate in this clinical trial?
After you have discussed the trial with your doctor, contact CymaBay Therapeutics, Inc. to coordinate with the study site closest to where you live.
The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.