53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188

  
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004387-54-BG
(EUCTR)
09/03/202124/07/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;United Kingdom;Switzerland;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
2EUCTR2018-004387-54-GB
(EUCTR)
02/12/201930/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;United Kingdom;Switzerland;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
3EUCTR2018-004387-54-DK
(EUCTR)
21/10/201916/07/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn 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
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Estonia;Taiwan;Slovakia;Spain;Russian Federation;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Czechia;Turkey;Lithuania;United Kingdom;Hungary;Belgium;Brazil;Romania;Bulgaria;Germany;Japan
4EUCTR2018-004387-54-BE
(EUCTR)
26/08/201901/07/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn 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
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Estonia;Taiwan;Slovakia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;China;Czechia;Turkey;Lithuania;United Kingdom;Hungary;Brazil;Belgium;Romania;Bulgaria;Germany;Japan
5EUCTR2018-004387-54-ES
(EUCTR)
21/08/201908/05/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn 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: Aún no establecido
Product Code: LOU064
INN or Proposed INN: Aún no establecido
Product Code: LOU064
INN or Proposed INN: Aún no establecido
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
252 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China
6NCT04035668
(ClinicalTrials.gov)
July 12, 20198/7/2019A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's SyndromeAn 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 SyndromeDrug: Remibrutinib;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years75 YearsAll73Phase 2United States;Australia;Belgium;Bulgaria;China;Denmark;Germany;Hungary;Spain;Switzerland;Taiwan;United Kingdom
7EUCTR2018-004387-54-HU
(EUCTR)
24/06/201929/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
8EUCTR2018-004387-54-DE
(EUCTR)
20/05/201903/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn 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
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Taiwan;Estonia;Slovakia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;China;Czechia;Turkey;Lithuania;United Kingdom;Hungary;Belgium;Brazil;Romania;Bulgaria;Germany;Japan