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
| 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 | NCT05349214 (ClinicalTrials.gov) | August 4, 2022 | 8/4/2022 | Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome | A Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-2) | Sjogren Syndrome | Biological: VAY736;Other: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 489 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;China;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Lebanon;Mexico;Poland;Romania;Slovakia;Spain;Sweden;Taiwan;United Kingdom |
| 2 | EUCTR2021-005687-22-SK (EUCTR) | 01/08/2022 | 12/05/2022 | A clinical study to investigate ianalumab is effective and safe in the treatment of active Sjögren`s syndrome | A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2) - NEPTUNUS-2 | Active Sjögren’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 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 489 | Phase 3 | United States;Taiwan;Slovakia;Greece;Spain;Lebanon;Israel;Chile;Colombia;Italy;India;France;Australia;Peru;South Africa;China;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 3 | NCT05350072 (ClinicalTrials.gov) | July 28, 2022 | 7/4/2022 | Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome | A Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1) | Sjogren Syndrome | Biological: VAY736;Other: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 285 | Phase 3 | United States;Austria;Brazil;China;Czechia;France;Germany;Guatemala;Korea, Republic of;Lithuania;Poland;Portugal;Singapore;Spain;Turkey |
| 4 | EUCTR2021-005687-22-HU (EUCTR) | 24/05/2022 | 11/04/2022 | A clinical study to investigate ianalumab is effective and safe in the treatment of active Sjögren`s syndrome | A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2) - NEPTUNUS-2 | Active Sjögren’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 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 489 | Phase 3 | United States;Taiwan;Slovakia;Greece;Spain;Lebanon;Israel;Chile;Colombia;Italy;India;France;Australia;Peru;South Africa;China;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 5 | EUCTR2020-005055-20-FR (EUCTR) | 25/04/2022 | 10/11/2021 | A clinical study with biopsy to investigate how ianalumab works in Sjögren`s and how safe it is | An open-label, non-randomized, biopsy-based mechanistic study on efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome - Biopsy-based mechanistic study | Sjögren'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 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | France | ||
| 6 | EUCTR2016-003292-22-IT (EUCTR) | 20/11/2017 | 25/05/2021 | Study 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. - Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) | 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 | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Germany;Netherlands;Japan | ||
| 7 | EUCTR2016-003292-22-PL (EUCTR) | 28/09/2017 | 23/08/2017 | Study 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Germany;Netherlands;Japan | ||
| 8 | EUCTR2016-003292-22-NL (EUCTR) | 25/07/2017 | 19/04/2017 | Study 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 9 | EUCTR2016-003292-22-BE (EUCTR) | 17/07/2017 | 26/04/2017 | Study 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 10 | EUCTR2016-003292-22-HU (EUCTR) | 29/06/2017 | 20/04/2017 | Study 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;United States;Portugal;Taiwan | ||
| 11 | NCT02962895 (ClinicalTrials.gov) | June 27, 2017 | 3/11/2016 | Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS) | Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS) | Primary Sjogren Syndrome | Biological: VAY736;Other: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 192 | Phase 2 | United States;Argentina;Austria;Belgium;Chile;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Taiwan;United Kingdom |
| 12 | EUCTR2016-003292-22-AT (EUCTR) | 19/06/2017 | 17/05/2017 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 13 | EUCTR2016-003292-22-FR (EUCTR) | 09/06/2017 | 11/04/2017 | Study 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 14 | EUCTR2016-003292-22-DE (EUCTR) | 06/06/2017 | 06/03/2017 | Study 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 15 | EUCTR2016-003292-22-PT (EUCTR) | 05/06/2017 | 20/03/2017 | Study 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 16 | EUCTR2016-003292-22-GB (EUCTR) | 26/05/2017 | 20/03/2017 | Study 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 17 | EUCTR2016-003292-22-ES (EUCTR) | 06/04/2017 | 10/03/2017 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 18 | NCT02495129 (ClinicalTrials.gov) | December 2015 | 8/7/2015 | Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome | A Three-part, Partially Open Label and Double-blind, Randomized Study to Assess the Pharmacodynamic Effects, Safety, Tolerability and Preliminary Efficacy of VAY736 in Patients With Primary Sjögren's Syndrome Using [Zr-89]-Rituximab PET/CT | Primary Sjögren's Syndrome | Drug: VAY736 lower dose;Drug: VAY736 higher dose | Novartis Pharmaceuticals | NULL | Withdrawn | N/A | N/A | All | 0 | Phase 1/Phase 2 | Netherlands |
| 19 | NCT02149420 (ClinicalTrials.gov) | May 23, 2014 | 9/9/2013 | PD of VAY736 in Patients With Primary Sjögren's Syndrome | A Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 27 | Phase 2 | Germany;France;Netherlands;United States |
| 20 | EUCTR2013-000250-22-DE (EUCTR) | 11/04/2014 | 16/10/2013 | A single dose study to assess the effect of VAY736 in patients with primary Sjögren’s syndrome | A single dose, double-blind, placebo-controlled, parallel study to assess the pharmacodynamics, pharmacokinetics and safety and tolerability of VAY736 in patients with primary Sjögren’s syndrome - CVAY736X2201 | Seropositive primary Sjögren’s syndrome MedDRA version: 19.0;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: VAY736 Other descriptive name: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Germany |