94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details
臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
| 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 | EUCTR2019-002945-39-ES (EUCTR) | 20/01/2022 | 19/10/2021 | A study to look at how well study drug CM-101 works in people with disease of the liver and gallbladder characterized by inflammation and scarring of the bile ducts | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study | Primary Sclerosing Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CM-101 Product Code: CM-101 INN or Proposed INN: TBC Other descriptive name: Humanised IgG1 monoclonal antibody against human eotaxin-2 | ChemomAb Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | Spain;Israel;United Kingdom | ||
| 2 | NCT04595825 (ClinicalTrials.gov) | October 1, 2020 | 7/10/2020 | CM-101 in PSC Patients -The SPRING Study | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating The Safety And Efficacy Of CM-101 In Subjects With Primary Sclerosing Cholangitis- The SPRING Study | Primary Sclerosing Cholangitis | Biological: CM-101;Other: Placebo | ChemomAb Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 45 | Phase 2 | Germany;Israel;United Kingdom |
| 3 | EUCTR2019-002945-39-GB (EUCTR) | 15/04/2020 | 14/11/2019 | A study to look at how well study drug CM-101 works in people with disease of the liver and gallbladder characterized by inflammation and scarring of the bile ducts | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study | Primary Sclerosing Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CM-101 Product Code: CM-101 INN or Proposed INN: TBC Other descriptive name: Humanised IgG1 monoclonal antibody against human eotaxin-2 | ChemomAb Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | Israel;United Kingdom | ||
| 4 | EUCTR2018-004258-77-GB (EUCTR) | 05/02/2019 | 26/11/2018 | A phase 2 study being run in multiple centres to evaluate the safety, tolerability and efficacy of a study drug (called CM-101) which will be given to patients with primary sclerosing cholangitis for 12 weeks. | A Phase 2, Open Label, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of CM-101 Administered for 12 Weeks in Adult Subjects with Primary Sclerosing Cholangitis. - The SPRING Study | Treatment of Primary Sclerosing Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CM-101 | ChemomAb Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Israel;United Kingdom |