Remibrutinib (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 53 | シェーグレン症候群 | 3 |
| 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 | EUCTR2018-004387-54-GB (EUCTR) | 02/12/2019 | 30/04/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) | Sjögren’s Syndrome (SjS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Switzerland;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China | ||
| 2 | EUCTR2018-004387-54-DK (EUCTR) | 21/10/2019 | 16/07/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) | Sjögren’s Syndrome (SjS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Denmark;Australia;Bulgaria;Germany;China | ||
| 3 | EUCTR2018-004387-54-DE (EUCTR) | 20/05/2019 | 03/04/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) | Sjögren’s Syndrome (SjS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Other descriptive name: LOU064 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China |