Lou064 (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 53 | Sjogren syndrome | 7 |
| 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-BE (EUCTR) | 26/08/2019 | 01/07/2019 | 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: 20.0;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: Not yet established Product Code: LOU064 INN or Proposed INN: Not yet established Product Code: LOU064 INN or Proposed INN: Not yet established | 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 | ||
| 4 | EUCTR2018-004387-54-ES (EUCTR) | 21/08/2019 | 08/05/2019 | 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: 20.0;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] | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China | |||
| 5 | NCT04035668 (ClinicalTrials.gov) | July 12, 2019 | 8/7/2019 | A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe 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 Syndrome | Drug: LOU064;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 252 | Phase 2 | United States;Australia;Belgium;Bulgaria;China;Denmark;Germany;Hungary;Spain;Switzerland;Taiwan;United Kingdom |
| 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 |
| 6 | EUCTR2018-004387-54-HU (EUCTR) | 24/06/2019 | 29/04/2019 | 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: 20.0;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: Not yet established Product Code: LOU064 INN or Proposed INN: Not yet established Product Code: LOU064 INN or Proposed INN: Not yet established | 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;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China | ||
| 7 | 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 |