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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (AFFIRM)

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ClinicalTrials.gov Identifier: NCT06051617
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : April 10, 2024
Sponsor:
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

Study Description
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Brief Summary:
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Drug: Seladelpar 10 mg Drug: Placebo Phase 3

Detailed Description:
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Actual Study Start Date : September 7, 2023
Estimated Primary Completion Date : July 2029
Estimated Study Completion Date : July 2029

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Seladelpar 10 mg Drug: Seladelpar 10 mg
Seladelpar 10 mg one capsule daily for up to 36 months.
Placebo Comparator: Placebo Drug: Placebo
One capsule daily for up to 36 months.


Outcome Measures
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Primary Outcome Measures :
  1. Event Free Survival (EFS) [ Time Frame: 36 months ]

    EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events:

    1. Death by any cause;
    2. Liver transplantation;
    3. MELD score ≥15;
    4. Ascites requiring treatment;
    5. Hospitalization for esophagus or stomach varices


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]
    Time from start of treatment to death from any cause.

  2. Liver transplant-free survival [ Time Frame: 36 months ]
    Time from start of treatment to the first occurrence of liver-related death or liver liver transplantation.

  3. Time to hospitalization [ Time Frame: 36 months ]
    Time from start of treatment for esophagus or stomach varices

  4. Time to Event Free Survival (EFS) [ Time Frame: 36 months ]
    1. MELD score ≥15
    2. Ascites requiring treatment
    3. progression to Child-Pugh-C (advanced hepatic dysfunction)


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:

Subjects must meet the following criteria to be eligible for study participation:

  1. Must be 18 to 75 years old (inclusive)
  2. Must have a confirmed prior diagnosis of PBC
  3. Evidence of cirrhosis
  4. CP Score A or B
  5. 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
  6. Subjects must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

Exclusion Criteria:

Subjects must not meet any of the following criteria to be eligible for study participation:

  1. Prior exposure to seladelpar
  2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
  3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
  4. Decompensated cirrhosis
  5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
  6. Hospitalization for liver-related complication within 12 weeks of Screening

  7. Laboratory parameters at Screening:

    1. ALP ≥10×ULN
    2. ALT or AST ≥5×ULN
    3. TB ≥5×ULN
    4. Platelet count ≤75×10^3/µL
    5. Albumin ≤2.8 g/dL
    6. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2
    7. MELD score >12. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
    8. Serum alpha-fetoprotein (AFP) >20 ng/mL
    9. INR >1.7
  8. CP-C cirrhosis
  9. History or presence of other concomitant liver diseases
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): NCT06051617


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: NCT06051617    
Other Study ID Numbers: CB8025-41837
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
Primary Biliary Cholangitis (PBC)
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