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

Gilead Sciences

Status and phase: Enrolling; Phase 3

Conditions: Primary Biliary Cholangitis

Treatments: Drug: Seladelpar; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06051617

2024-516525-31 (Other Identifier)

CB8025-41837

Details and patient eligibility

About

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

Full description

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

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

1. Must be at least 18 years old.
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 ≤50×10^3/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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 2 patient groups, including a placebo group

Seladelpar

Experimental group

Treatment:

Drug: Seladelpar

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo