Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
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ClinicalTrials.gov Identifier: NCT03301506 |
Recruitment Status :
Recruiting
First Posted : October 4, 2017
Last Update Posted : April 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Biliary Cirrhosis | Drug: Seladelpar 5 mg Capsule Drug: Seladelpar 10 mg Capsule | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) |
Actual Study Start Date : | December 12, 2017 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Seladelpar 5 mg Capsules |
Drug: Seladelpar 5 mg Capsule
Subjects will be assigned to a treatment group if tolerability issues noted in the previous study.
Other Name: MBX-8025 |
Experimental: Seladelpar 10 mg Capsule |
Drug: Seladelpar 10 mg Capsule
Subjects will be assigned to a treatment group unless there are tolerability issues.
Other Name: MBX-8025 |
- Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results [ Time Frame: Through study completion, up to 60 Months ]
- Death [ Time Frame: 60 Months ]Occurrence of overall death
- Liver transplantation [ Time Frame: 60 Months ]Occurrence of overall liver transplantation
- Change in MELD [ Time Frame: 60 Months ]MELD score ≥ 15 for at least 2 consecutive visits
- Ascites [ Time Frame: 60 Months ]Occurrence of overall ascites requiring treatment
- Hospitalization for variceal bleeding [ Time Frame: 60 Months ]Hospitalization for new onset, or recurrence, of variceal bleeding
- Hospitalization for hepatic encephalopathy [ Time Frame: 60 Months ]Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)
- Hospitalization for spontaneous bacterial peritonitis [ Time Frame: 60 Months ]Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
- Response on composite endpoint [ Time Frame: 60 Months ]Alkaline phosphate (ALP)
- Response on composite endpoint [ Time Frame: 60 Months ]Total bilirubin
- Normalization of ALP [ Time Frame: 60 Months ]Proportion of subjects with normalization of ALP
- Laboratory Value: Serum Alkaline Phosphatase (ALP) [ Time Frame: Through study completion, up to 60 Months ]Serum Alkaline Phosphatase (ALP)
- Laboratory Value: Aspartate Aminotransferase (AST) [ Time Frame: Through study completion, up to 60 Months ]Aspartate Aminotransferase (AST)
- Laboratory Value: Alanine Aminotransferase (ALT) [ Time Frame: Through study completion, up to 60 Months ]Alanine Aminotransferase (ALT)
- Laboratory Value: Gamma-glutamyl Transferase (GGT) [ Time Frame: Through study completion, up to 60 Months ]Gamma-glutamyl Transferase (GGT)
- Laboratory Value: Bilirubin - Total Bilirubin [ Time Frame: Through study completion, up to 60 Months ]Bilirubin - Total Bilirubin
- Laboratory Value: Bilirubin - Conjugated Bilirubin [ Time Frame: Through study completion, up to 60 Months ]Bilirubin - Conjugated Bilirubin
- Laboratory Value: Bilirubin - Unconjugated Bilirubin [ Time Frame: Through study completion, up to 60 Months ]Bilirubin - Unconjugated Bilirubin

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must have given written informed consent (signed and dated)
- Participated in a PBC study with seladelpar
- Females of reproductive potential must use at least one 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:
Exclusion criteria are only applicable for subjects with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption.
- Treatment-related adverse event (AE) leading to seladelpar discontinuation in a previous PBC study with seladelpar (MBX-8025)
- A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
- AST or ALT above 3 × the upper limit of normal (ULN)
- Total bilirubin above 2 × ULN
- MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
- Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
- eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
- Auto-immune hepatitis
- Primary sclerosing cholangitis
- Known history of alpha-1-antitrypsin deficiency
- Known history of chronic viral hepatitis
- For females, pregnancy or breast-feeding
- Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
- Current use of fibrates or use of fibrates within 3 months prior to Screening
- Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
- Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
- History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
- Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
- 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
- Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
- Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis
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Positive for:
- Hepatitis B, defined as the presence of hepatitis B surface antigen
- Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
- Human immunodeficiency virus (HIV) antibody
- Active COVID-19 infection during screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301506
Contact: Barry Crittenden, MD | 510-293-8800 | medinfo@cymabay.com |

Responsible Party: | CymaBay Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03301506 |
Other Study ID Numbers: |
CB8025-31731 |
First Posted: | October 4, 2017 Key Record Dates |
Last Update Posted: | April 18, 2023 |
Last Verified: | April 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
PBC Primary Biliary Cholangitis (PBC) |
Cholangitis Liver Cirrhosis, Biliary Fibrosis Pathologic Processes Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Cholestasis, Intrahepatic |
Cholestasis Liver Diseases Liver Cirrhosis Seladelpar Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |