VAY736 antibody ( 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10

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
1EUCTR2016-003292-22-PL
(EUCTR)
28/09/201723/08/2017Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome Primary Sjogren’s syndrome
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 Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Germany;Netherlands;Japan
2EUCTR2016-003292-22-NL
(EUCTR)
25/07/201719/04/2017Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doserangingstudy to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primarySjogren's Syndrome Primary Sjogren’s syndrome
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 Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
3EUCTR2016-003292-22-BE
(EUCTR)
17/07/201726/04/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome. Primary Sjogren’s syndrome
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 Name: Ianalumab
Product Code: VAY736
INN or Proposed INN: Ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
4EUCTR2016-003292-22-HU
(EUCTR)
29/06/201720/04/2017Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome Primary Sjogren’s syndrome
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: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;United States;Portugal;Taiwan
5EUCTR2016-003292-22-AT
(EUCTR)
19/06/201717/05/2017A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome Primary Sjogren’s syndrome
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 Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
6EUCTR2016-003292-22-FR
(EUCTR)
09/06/201711/04/2017Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 19.1;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: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
7EUCTR2016-003292-22-DE
(EUCTR)
06/06/201706/03/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome Primary Sjogren’s syndrome
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 Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
8EUCTR2016-003292-22-PT
(EUCTR)
05/06/201720/03/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome Primary Sjogren’s syndrome
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 Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
9EUCTR2016-003292-22-GB
(EUCTR)
26/05/201720/03/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome Primary Sjogren’s syndrome
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 Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
10EUCTR2016-003292-22-ES
(EUCTR)
06/04/201710/03/2017Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 19.1;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: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan