Completed PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT05104853

Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis

A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA

Sponsor: COUR Pharmaceutical Development Company, Inc.

Conditions Primary Biliary Cholangitis

Interventions CNP-104 Placebo

Updated 20 times since 2021 Last updated: Mar 6, 2026 Started: Jan 25, 2022 Primary completion: Jan 30, 2026 Completion: Jan 30, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05104853, this PHASE1/PHASE2 trial focuses on Primary Biliary Cholangitis and remains completed. Sponsored by COUR Pharmaceutical Development Company, Inc., it has been updated 20 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

20 versions recorded

Mar 2026 — Present [monthly]

Completed PHASE1/PHASE2

Status: Active Not Recruiting → Completed
Sep 2025 — Mar 2026 [monthly]

Active Not Recruiting PHASE1/PHASE2
Dec 2024 — Sep 2025 [monthly]

Active Not Recruiting PHASE1/PHASE2
Nov 2024 — Dec 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2
Sep 2024 — Nov 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2

▶ Show 15 earlier versions

Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Apr 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Recruiting → Active Not Recruiting
Feb 2024 — Apr 2024 [monthly]

Recruiting PHASE1_PHASE2
Nov 2023 — Feb 2024 [monthly]

Recruiting PHASE1_PHASE2
Oct 2023 — Nov 2023 [monthly]

Recruiting PHASE1_PHASE2
Aug 2023 — Oct 2023 [monthly]

Recruiting PHASE1_PHASE2
Feb 2023 — Aug 2023 [monthly]

Recruiting PHASE1_PHASE2
Dec 2022 — Feb 2023 [monthly]

Recruiting PHASE1_PHASE2
Nov 2022 — Dec 2022 [monthly]

Recruiting PHASE1_PHASE2
Sep 2022 — Nov 2022 [monthly]

Recruiting PHASE1_PHASE2
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE1_PHASE2
May 2022 — Jul 2022 [monthly]

Recruiting PHASE1_PHASE2
Mar 2022 — May 2022 [monthly]

Recruiting PHASE1_PHASE2

Status: Not Yet Recruiting → Recruiting
Feb 2022 — Mar 2022 [monthly]

Not Yet Recruiting PHASE1_PHASE2
Dec 2021 — Feb 2022 [monthly]

Not Yet Recruiting PHASE1_PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

COUR Pharmaceutical Development Company, Inc.

Data source: COUR Pharmaceutical Development Company, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Boston, United States , Charlottesville, United States , Chicago, United States , Colorado Springs, United States , Coronado, United States , Durham, United States , Gainesville, United States , Jacksonville, United States , Lakewood Rch, United States and 9 more locations