93. Primary biliary cholangitis Clinical trials / Disease details
Clinical trials : 298 / Drugs : 252 - (DrugBank : 59) / Drug target genes : 35 - Drug target pathways : 115
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003365-34-GB (EUCTR) | 02/05/2019 | 11/02/2019 | A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA | A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA | Primary Biliary Cholangitis MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 52 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Italy;United Kingdom | ||
| 2 | EUCTR2018-003365-34-IT (EUCTR) | 18/04/2019 | 03/08/2021 | A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA. | A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA. - na | Primary Biliary Cholangitis MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] Other descriptive name: baricitinib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | United States;United Kingdom;Italy | ||
| 3 | NCT03742973 (ClinicalTrials.gov) | March 28, 2019 | 14/11/2018 | A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA | A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Primary Biliary Cholangitis Who Have an Inadequate Response or Are Intolerant to UDCA | Primary Biliary Cholangitis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 2 | United States;Puerto Rico;Italy;United Kingdom |