LOU064 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎12
53シェーグレン症候群8

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2071220034
02/08/202203/08/2022A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multipleA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib - Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinib. Relapsing Multiple SclerosisCore Part
-Remibrutinib(LOU064) tablet and matching placebo of teriflunomide capsule
-Teriflunomide capsule and matching placebo LOU064 tablet

Extension part
LOU064 tablet
Yamada HiroyukiNULLRecruiting>= 18age old<= 55age oldBoth30Phase 3US;Italy;Portugal;South Africa;France;Poland;Slovakia;Slovenia;Spain;Sweden;Turkey;Japan
2EUCTR2020-005929-89-GR
(EUCTR)
17/06/202216/12/2021Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extendedtreatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
3EUCTR2020-005899-36-LV
(EUCTR)
01/06/202205/04/2022Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Serbia;United States;Hong Kong;Slovakia;Spain;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Latvia;Netherlands;China;Czechia;Guatemala;Lithuania;United Kingdom;Hungary;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany
4EUCTR2020-005929-89-PL
(EUCTR)
26/04/202211/03/2022Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study,comparing the efficacy and safety of remibrutinib versus teriflunomide inparticipants with relapsing multiple sclerosis, followed by extendedtreatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
5EUCTR2020-005929-89-HR
(EUCTR)
15/04/202204/05/2022Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Bulgaria;Germany;Sweden
6EUCTR2020-005899-36-HR
(EUCTR)
15/04/202204/05/2022Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Hong Kong;Slovakia;Spain;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Latvia;Netherlands;China;Czechia;Guatemala;Lithuania;United Kingdom;Hungary;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany
7EUCTR2020-005929-89-SI
(EUCTR)
04/04/202204/01/2022Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Germany;Sweden
8EUCTR2020-005899-36-IT
(EUCTR)
09/03/202226/11/2021Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib 100 mg b.i.d. versus teriflunomide 14 mg q.d. in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib - - Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: [L04AA31]
INN or Proposed INN: Teriflunomide
Product Name: remibrutinib
Product Code: [LOU064C1]
INN or Proposed INN: Remibrutinib
Other descriptive name: LOU064C1
Product Name: colestiramina
Product Code: [-]
INN or Proposed INN: COLESTIRAMINA
Product Name: Carbone vegetale polvere
Product Code: [-]
INN or Proposed INN: CARBONE VEGETALE
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Hong Kong;Slovakia;Spain;Guatemala;Chile;Russian Federation;Colombia;Italy;Switzerland;United Kingdom;India;Argentina;Malaysia;China
9EUCTR2020-005899-36-SK
(EUCTR)
21/02/202222/11/2021Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Serbia;Hong Kong;Slovakia;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Latvia;Netherlands;China;Czechia;Guatemala;Lithuania;United Kingdom;Hungary;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany
10EUCTR2020-005929-89-ES
(EUCTR)
11/02/202222/12/2021Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study,comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Farmacéutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
11EUCTR2020-005899-36-ES
(EUCTR)
11/02/202229/12/2021Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Farmacéutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Slovakia;Spain
12EUCTR2020-005929-89-SE
(EUCTR)
01/02/202209/11/2021Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis, followed by long term treatment with remibrutinibA randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: remibrutinib
Product Code: LOU064
INN or Proposed INN: Remibrutinib
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: Teriflunomide
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Italy;India;France;South Africa;China;Czechia;Slovenia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Germany;Sweden

53. シェーグレン症候群


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
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