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)

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Primary Biliary Cholangitis

Intervention / Treatment
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* Drug: Seladelpar 10 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seladelpar 10 mg<br> | Drug: Seladelpar 10 mg<br>* Seladelpar 10 mg one capsule daily for up to 52 weeks<br>|
| Experimental: Placebo<br> | Drug: Placebo<br>* One capsule daily for up to 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve normalization of ALP (ALP ≤ ULN). |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Biliary Cholangitis (PBC), PBC