IANALUMAB ( DrugBank: Ianalumab )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 35 | 天疱瘡 | 1 |
| 46 | 悪性関節リウマチ | 1 |
| 49 | 全身性エリテマトーデス | 4 |
| 53 | シェーグレン症候群 | 9 |
| 95 | 自己免疫性肝炎 | 7 |
35. 天疱瘡
臨床試験数 : 98 / 薬物数 : 126 - (DrugBank : 41) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 168
| 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 | EUCTR2013-001217-33-AT (EUCTR) | 25/11/2013 | 03/10/2013 | Study of efficacy and safety of VAY736 in patients with Pemphigus vulgaris | A randomized, partial-blind, placebo-controlled trial evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of VAY736 in the treatment of patients with pemphigus vulgaris | Pemphigus vulgaris MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Austria;Bulgaria |
46. 悪性関節リウマチ
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| 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 | NCT03574545 (ClinicalTrials.gov) | December 19, 2018 | 21/6/2018 | Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: ianalumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 1 | Germany;Jordan |
49. 全身性エリテマトーデス
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | EUCTR2018-001508-12-FR (EUCTR) | 05/02/2019 | 13/11/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Korea, Republic of;Japan;China;Germany;Australia;Poland;Argentina;Hungary;Czech Republic;France;Israel;Russian Federation;Thailand;Spain;Taiwan | ||
| 2 | EUCTR2018-001508-12-ES (EUCTR) | 12/12/2018 | 09/10/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 3 | EUCTR2018-001508-12-DE (EUCTR) | 05/12/2018 | 28/08/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2 | United States;Czechia;Taiwan;Thailand;Spain;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 4 | EUCTR2018-001508-12-CZ (EUCTR) | 02/11/2018 | 28/08/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of |
53. シェーグレン症候群
臨床試験数 : 283 / 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
| 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 | NCT05124925 (ClinicalTrials.gov) | January 26, 2022 | 8/11/2021 | Biopsy Study in Patients With Sjogren's Disease to Investigate Safety and Effect of Ianalumab on Salivary Glands | An Open-label, Non-randomized, Biopsy-based Mechanistic Study on Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ianalumab in Patients With Sjögren's Syndrome | Sjogren Syndrome | Biological: Ianalumab | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | N/A | All | 24 | Phase 2 | NULL |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 |
95. 自己免疫性肝炎
臨床試験数 : 52 / 薬物数 : 68 - (DrugBank : 28) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 112
| 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 | EUCTR2017-001555-32-DK (EUCTR) | 08/06/2018 | 08/06/2018 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER) - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Sweden;Switzerland;United Kingdom;Japan;Germany;Netherlands;Denmark;Spain;Belgium;Canada;Czech Republic;United States | ||
| 2 | EUCTR2017-001555-32-NL (EUCTR) | 26/04/2018 | 18/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2;Phase 3 | Sweden;Japan;Switzerland;United Kingdom;Netherlands;Germany;Denmark;Belgium;Spain;Canada;Czech Republic;United States | ||
| 3 | EUCTR2017-001555-32-BE (EUCTR) | 19/03/2018 | 18/12/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czechia;Spain;Switzerland;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 4 | EUCTR2017-001555-32-DE (EUCTR) | 01/02/2018 | 12/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czechia;Spain;Switzerland;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 5 | EUCTR2017-001555-32-GB (EUCTR) | 16/01/2018 | 20/11/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 6 | EUCTR2017-001555-32-SE (EUCTR) | 19/12/2017 | 02/11/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: anti-BAFFR antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Japan;United Kingdom;Switzerland;Sweden | ||
| 7 | EUCTR2017-001555-32-CZ (EUCTR) | 13/10/2017 | A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver | A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER) - AMBER | Autoimmune Hepatitis (AIH) MedDRA version: 20.1;Level: PT;Classification code 10003827;Term: Autoimmune hepatitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab | Novartis Pharma AG | NULL | NA | Female: yes Male: yes | 80 | Phase 2;Phase 3 | United States;Czechia;Spain;United Kingdom;Switzerland;Czech Republic;Canada;Argentina;Belgium;Singapore;Denmark;Germany;Netherlands;Japan;Sweden |