A Confirmatory Study (Phase 3) of KC-8025 in Patients with Primary Biliary Cholangitis and Inadequate Response to or Intolerance of Ursodeoxycholic Acid

JRCT ID: jRCT2071240075

Registered date:06/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Primary Biliary Cholangitis
• Date of first enrollment: 01/02/2025
• Target sample size: 29
• Study type: Interventional
• Intervention(s): KC-8025 10 mg will be taken orally once daily, and one capsule will be taken per dose for 52 weeks. Administration of UDCA will be continued at the dosage and administration which was continued for at least 3 months prior to screening until 52 weeks are performed (except in patients with UDCA intolerance).

Outcome(s)

• Primary Outcome: Achievement of the composite endpoint (ALP < 1.67 * ULN, ALP reduction of at least 15% from baseline, and total bilirubin <= ULN) (at Week 52)

Secondary Outcome

- Amount and percent change from baseline in ALP
- Change from baseline in the mean Itch NRS score
- Achievement of the composite endpoint (at Week 4, 12, 26, 39)
- Other secondary endpoints defined in the clinical study protocol

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patients who meet 2 of the following 3 diagnostic criteria and have been diagnosed with PBC
1. It can be confirmed based on the following records that ALP was above ULN for at least 6 months
2. Positive anti-mitochondrial antibody or positive PBC-specific antinuclear antibody test at screening
3. Findings consistent with PBC are observed on liver biopsy
- Patients with the laboratory test values defined in the clinical study protocol at screening
- Patients who are at least 18 years old at the time when informed consent is obtained
- Meet all other Inclusion criteria defined in the clinical study protocol

Exclude criteria

- Patients with other chronic liver diseases as defined in the clinical study protocol
- Patients who used a fibrate (bezafibrate, pemafibrate, etc.) or obeticholic acid within 42 days prior to screening
- Female patients who are pregnant, breastfeeding, or may be pregnant, or who wish to become pregnant after providing informed consent until 90 days after the last dose of the investigational product, or male patients who wish to father a child. Female patients of childbearing potential with a positive pregnancy test at screening
- Meet any other exclusion criteria defined in the clinical study protocol

Related Information

• Primary Sponsor: Kawabata Hideki