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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 : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

Study Description
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Brief Summary:
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Seladelpar 5 mg Capsule Drug: Seladelpar 10 mg Capsule Phase 3

Detailed Description:

Primary:

To evaluate the long-term safety and tolerability of seladelpar

Secondary:

  • To evaluate the long-term efficacy of seladelpar
  • To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 60 Months ]
    Occurrence of overall death

  2. Liver transplantation [ Time Frame: 60 Months ]
    Occurrence of overall liver transplantation

  3. Change in MELD [ Time Frame: 60 Months ]
    MELD score ≥ 15 for at least 2 consecutive visits

  4. Ascites [ Time Frame: 60 Months ]
    Occurrence of overall ascites requiring treatment

  5. Hospitalization for variceal bleeding [ Time Frame: 60 Months ]
    Hospitalization for new onset, or recurrence, of variceal bleeding

  6. Hospitalization for hepatic encephalopathy [ Time Frame: 60 Months ]
    Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)

  7. Hospitalization for spontaneous bacterial peritonitis [ Time Frame: 60 Months ]
    Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)

  8. Response on composite endpoint [ Time Frame: 60 Months ]
    Alkaline phosphate (ALP)

  9. Response on composite endpoint [ Time Frame: 60 Months ]
    Total bilirubin

  10. Normalization of ALP [ Time Frame: 60 Months ]
    Proportion of subjects with normalization of ALP

  11. Laboratory Value: Serum Alkaline Phosphatase (ALP) [ Time Frame: Through study completion, up to 60 Months ]
    Serum Alkaline Phosphatase (ALP)

  12. Laboratory Value: Aspartate Aminotransferase (AST) [ Time Frame: Through study completion, up to 60 Months ]
    Aspartate Aminotransferase (AST)

  13. Laboratory Value: Alanine Aminotransferase (ALT) [ Time Frame: Through study completion, up to 60 Months ]
    Alanine Aminotransferase (ALT)

  14. Laboratory Value: Gamma-glutamyl Transferase (GGT) [ Time Frame: Through study completion, up to 60 Months ]
    Gamma-glutamyl Transferase (GGT)

  15. Laboratory Value: Bilirubin - Total Bilirubin [ Time Frame: Through study completion, up to 60 Months ]
    Bilirubin - Total Bilirubin

  16. Laboratory Value: Bilirubin - Conjugated Bilirubin [ Time Frame: Through study completion, up to 60 Months ]
    Bilirubin - Conjugated Bilirubin

  17. Laboratory Value: Bilirubin - Unconjugated Bilirubin [ Time Frame: Through study completion, up to 60 Months ]
    Bilirubin - Unconjugated Bilirubin


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must have given written informed consent (signed and dated)
  2. Participated in a PBC study with seladelpar
  3. 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.

  1. Treatment-related adverse event (AE) leading to seladelpar discontinuation in a previous PBC study with seladelpar (MBX-8025)
  2. 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)
  3. AST or ALT above 3 × the upper limit of normal (ULN)
  4. Total bilirubin above 2 × ULN
  5. 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.
  6. 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)
  7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
  8. Auto-immune hepatitis
  9. Primary sclerosing cholangitis
  10. Known history of alpha-1-antitrypsin deficiency
  11. Known history of chronic viral hepatitis
  12. For females, pregnancy or breast-feeding
  13. 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
  14. Current use of fibrates or use of fibrates within 3 months prior to Screening
  15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
  16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
  17. 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
  18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
  19. 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
  20. Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
  21. 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

  22. Positive for:

    1. Hepatitis B, defined as the presence of hepatitis B surface antigen
    2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
    3. Human immunodeficiency virus (HIV) antibody
  23. Active COVID-19 infection during screening
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Barry Crittenden, MD 510-293-8800 medinfo@cymabay.com

Locations
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Sponsors and Collaborators
CymaBay Therapeutics, Inc.
More Information
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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: February 15, 2024
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CymaBay Therapeutics, Inc.:
PBC
Primary Biliary Cholangitis (PBC)
Additional relevant MeSH terms:
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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