10 completed, 5 terminated, 3 not yet recruiting, 3 recruiting. 23 Phase 2, 4 Phase 3, 2 Phase 1.
Follow Primary Biliary Cholangitis: new trials by email Literature Review of Primary Biliary Cholangitis trials Research Report on Primary Biliary Cholangitis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus Nemolizumab-ilto - Chronic Hepatic Pruritus, Cholestatic Liver Disease | Phase 2 | Not yet recruiting | Mayo Clinic | 15 | 2026-11-01 | 2026-09-28 |
| Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis Seladelpar, PTM Seladelpar, Cilofexor Dose B - Primary Biliary Cholangitis | Phase 2 | Recruiting | Gilead Sciences | 132 | 2026-10-01 | 2026-10-27 |
| Phase I/II Trial of Human Umbilical Cord Mesenchymal Stromal Cells for UDCA-Refractory Primary Biliary Cholangitis Standard background therapy, Placebo, hUC-MSC Dose Level 1 - Primary Biliary Cholangitis | Phase 1 / Phase 2 | Not yet recruiting | Beijing 302 Hospital | 68 | 2026-08-31 | 2026-08-31 |
| TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis Nalmefene, Placebo - Pruritus, Primary Biliary Cholangitis | Phase 2 | Not yet recruiting | Tharimmune Inc | 40 | 2026-06-01 | 2025-09-09 |
| Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment. K-808 (Dose A), K-808 (Dose B), Placebo - Primary Biliary Cholangitis | Phase 2 | Completed | Kowa Research Institute, Inc. | 46 | 2024-02-07 | 2026-10-07 |
| Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis Fenofibrate, Placebo, UDCA - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Active not recruiting | Han Ying | 184 | 2023-08-21 | 2026-10-29 |
| Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis Fenofibrate 200mg, Placebo, UDCA - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 104 | 2023-02-17 | 2026-01-08 |
| Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis ASC42 5 mg, ASC42 10 mg, ASC42 15 mg - Primary Biliary Cholangitis | Phase 2 | Completed | Gannex Pharma Co., Ltd. | 98 | 2022-04-06 | 2024-09-27 |
| Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Placebo - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Completed | Zydus Therapeutics Inc. | 196 | 2022-04-01 | 2026-09-17 |
| Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg - Primary Biliary Cholangitis | Phase 2 | Completed | Intercept Pharmaceuticals | 72 | 2022-03-21 | 2026-07-16 |
| A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness Setanaxib, Placebo - Primary Biliary Cholangitis, Liver Stiffness | Phase 2 | Completed | Calliditas Therapeutics Suisse SA | 76 | 2022-02-14 | 2025-04-24 |
| Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis CNP-104, Placebo - Primary Biliary Cholangitis | Phase 1 / Phase 2 | Completed | COUR Pharmaceutical Development Company, Inc. | 42 | 2022-01-25 | 2026-03-10 |
| A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Volixibat, Placebo - Primary Biliary Cholangitis, PBC | Phase 2 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 333 | 2021-09-22 | 2026-08-25 |
| Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis HTD1801 (BUDCA) - Primary Biliary Cholangitis, Primary Biliary Cirrhosis | Phase 2 | Completed | HighTide Therapeutics (Hong Kong) Limited | 24 | 2021-05-27 | 2026-08-25 |
| Combination Antiretroviral Therapy (cART) for PBC Emtricitabine (FTC)/Tenofovir Disoproxil (TDF), Raltegravir, Placebo Oral Capsule [CEBOCAP] - Primary Biliary Cholangitis | Phase 2 | Completed | University of Alberta | 37 | 2021-03-01 | 2024-02-16 |
| Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC Obeticholic acid, Bezafibrate 200 MG, OCA Placebo - Primary Biliary Cholangitis | Phase 2 | Terminated | Intercept Pharmaceuticals | 75 | 2019-10-02 | 2026-07-16 |
| A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA Baricitinib, Placebo - Primary Biliary Cholangitis | Phase 2 | Terminated | Eli Lilly and Company | 2 | 2019-03-28 | 2020-10-14 |
| Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis APD334 - Primary Biliary Cholangitis | Phase 2 | Terminated | Arena Pharmaceuticals | 2 | 2017-12-29 | 2022-03-24 |
| A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis EDP-305 1 mg, EDP-305 2.5 mg, Placebo - Primary Biliary Cholangitis | Phase 2 | Completed | Enanta Pharmaceuticals, Inc | 68 | 2017-12-27 | 2021-05-18 |
| Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid E6011, Placebo - Primary Biliary Cholangitis | Phase 2 | Terminated | EA Pharma Co., Ltd. | 29 | 2017-05-29 | 2019-01-04 |
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Liver Cirrhosis, Biliary (23) · Cholangitis (2) · Cholestasis (2) · Fibrosis (2) · Pruritus (2) · Biliary Tract Diseases (1) · Cholangitis, Sclerosing (1) · Digestive System Diseases (1)
Bile Duct Diseases (23) · Cholestasis, Intrahepatic (23) · Liver Cirrhosis (23) · Liver Diseases (23) · Pathologic Processes (23) · Pathological Conditions, Signs and Symptoms (23) · Biliary Tract Diseases (22) · Digestive System Diseases (22) · Cholestasis (21) · Fibrosis (21) · Signs and Symptoms (2) · Skin Diseases (2) · Skin Manifestations (2) · Skin and Connective Tissue Diseases (2) · Cholangitis (1)
Fenofibrate (3) · Bezafibrate (2) · obeticholic acid (2) · (R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid (1) · EDP-305 (1) · Emtricitabine (1) · Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (1) · Raltegravir Potassium (1) · baricitinib (1) · cilofexor (1) · etrasimod (1) · nalmefene (1) · quetmolimab (1) · saroglitazar (1) · seladelpar (1)
Gilead Sciences (2) · Intercept Pharmaceuticals (2) · Xijing Hospital of Digestive Diseases (2) · Arena Pharmaceuticals (1) · Beijing 302 Hospital (1) · COUR Pharmaceutical Development Company, Inc. (1) · Calliditas Therapeutics Suisse SA (1) · EA Pharma Co., Ltd. (1) · Eli Lilly and Company (1) · Enanta Pharmaceuticals, Inc (1) · Gannex Pharma Co., Ltd. (1) · Han Ying (1) · HighTide Therapeutics (Hong Kong) Limited (1) · Kowa Research Institute, Inc. (1) · Mayo Clinic (1)
United States (14) · Canada (8) · China (6) · United Kingdom (6) · Germany (5) · Australia (4) · Belgium (4) · France (4) · Spain (4) · Argentina (3) · Austria (3) · Israel (3) · Italy (3) · Japan (3) · Netherlands (3)
Adrian DiBisceglie, MD (1) · Andre Belous, MD, PhD (1) · Andrew Mason, MD (1) · Arena CT.gov Administrator (1) · Christopher Bowlus, MD (1) · Deven V Parmar, MD (1) · Fu-Sheng Wang, MD, PhD (1) · Jason Sluzevich, MD (1) · Lynda Szczech (1) · Lynda Szczech, M.D. (1) · Ying Han (1)
PMID 40439725, PMID 10102814, PMID 21810549, PMID 24561556, PMID 24835895, PMID 25329189, PMID 29859173, PMID 30193962, PMID 32274345, PMID 35119627, PMID 35933430, PMID 36076306, PMID 36267872, PMID 36809835, PMID 38419761, PMID 39982546, PMID 40050288, PMID 40341605, PMID 40721581
2015 (1), 2016 (1)