CFZ533 ( DrugBank: - )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 11 | 重症筋無力症 | 3 |
| 46 | 悪性関節リウマチ | 1 |
| 49 | 全身性エリテマトーデス | 5 |
| 53 | シェーグレン症候群 | 26 |
11. 重症筋無力症
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| 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 | NCT02565576 (ClinicalTrials.gov) | September 29, 2015 | 23/6/2015 | Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Preliminarily Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of CFZ533 in Patients With Moderate to Severe Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: Placebo;Drug: CFZ533 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 44 | Phase 2 | Canada;Denmark;Germany;Russian Federation;Taiwan |
| 2 | EUCTR2015-000097-35-DK (EUCTR) | 03/09/2015 | 16/06/2015 | Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis | Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine. MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 Other descriptive name: CFZ533 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Canada;Denmark;Russian Federation;Germany | ||
| 3 | EUCTR2015-000097-35-DE (EUCTR) | 02/09/2015 | 05/06/2015 | Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis | Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine. MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 Other descriptive name: CFZ533 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Taiwan;Canada;Denmark;Russian Federation;Germany |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| 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 | NCT02089087 (ClinicalTrials.gov) | January 7, 2013 | 13/3/2014 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients | A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: CFZ533;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 75 | Phase 1 | United States;Taiwan |
49. 全身性エリテマトーデス
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| 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 | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 2 | NCT03656562 (ClinicalTrials.gov) | December 19, 2018 | 19/7/2018 | Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients | 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) | Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 Placebo | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 75 Years | All | 107 | Phase 2 | Spain;Taiwan;Thailand;Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;United States |
| 3 | 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 | ||
| 4 | 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 | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | United States;Czechia;Taiwan;Spain;Thailand;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 5 | 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 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 | Argentina;Russian Federation;Hungary;Japan;Thailand;Spain;Czech Republic;China;Taiwan;Korea, Republic of;Poland;Israel;Australia;France;Germany |
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. | 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 | EUCTR2020-001942-20-SE (EUCTR) | 20/04/2022 | 02/03/2022 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 2 | EUCTR2020-001942-20-NL (EUCTR) | 26/10/2021 | 10/05/2021 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 3 | EUCTR2020-001942-20-IT (EUCTR) | 14/04/2021 | 04/06/2021 | Study of safety and tolerability of CFZ533 in patients with Sjögren's Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome - Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | 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: iscalimab Product Code: [CFZ533] INN or Proposed INN: ISCALIMAB | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 4 | EUCTR2020-001942-20-PT (EUCTR) | 31/03/2021 | 10/11/2020 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 5 | EUCTR2020-001942-20-DE (EUCTR) | 09/02/2021 | 29/10/2020 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 6 | JPRN-jRCT2071200072 | 07/01/2021 | 21/12/2020 | Study of Safety and Tolerability of CFZ533 in Patients With Sjogren's Syndrome (TWINSS Extn) | A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjogren's Syndrome | Sjogren's Syndrome Sjogren's Syndrome, autoimmune, ESSDAI, ESSPRI, anti-CD40, CFZ533, iscalimab, TWINSS Extension | Arm 1 - Iscalimab Dose 1 Arm 2 - Iscalimab Dose 2 and Placebo | Yamada Hiroyuki | NULL | Recruiting | >= 18age old | <= 90age old | Both | 16 | Phase 2 | Australia;Hungary;Japan |
| 7 | NCT04541589 (ClinicalTrials.gov) | January 5, 2021 | 14/8/2020 | Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome | A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome | Sjögren's Syndrome | Drug: CFZ533 (iscalimab);Other: CFZ533 Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 90 Years | All | 214 | Phase 2 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Russian Federation;Sweden;Turkey;United Kingdom |
| 8 | EUCTR2020-001942-20-GR (EUCTR) | 04/12/2020 | 12/10/2020 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 9 | EUCTR2020-001942-20-HU (EUCTR) | 16/11/2020 | 17/09/2020 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Portugal | ||
| 10 | EUCTR2018-004476-35-RO (EUCTR) | 11/08/2020 | 27/04/2022 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 11 | EUCTR2018-004476-35-NL (EUCTR) | 26/03/2020 | 13/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 12 | EUCTR2018-004476-35-SE (EUCTR) | 22/01/2020 | 02/07/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 13 | EUCTR2018-004476-35-GB (EUCTR) | 07/01/2020 | 06/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 14 | EUCTR2018-004476-35-DE (EUCTR) | 22/10/2019 | 24/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 15 | NCT03905525 (ClinicalTrials.gov) | October 1, 2019 | 25/3/2019 | Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjögren's Syndrome | A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjögren's Syndrome (TWINSS) | Sjögren Syndrome | Drug: CFZ533;Other: Placebo | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 273 | Phase 2 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Russian Federation;Sweden;Turkey;United Kingdom;Slovenia |
| 16 | EUCTR2018-004476-35-AT (EUCTR) | 26/09/2019 | 10/07/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 17 | EUCTR2018-004476-35-IT (EUCTR) | 10/09/2019 | 28/04/2020 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 18 | EUCTR2018-004476-35-SI (EUCTR) | 06/09/2019 | 17/09/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of;United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France | ||
| 19 | EUCTR2018-004476-35-PT (EUCTR) | 19/08/2019 | 23/05/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 20 | EUCTR2018-004476-35-FR (EUCTR) | 13/08/2019 | 20/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 21 | EUCTR2018-004476-35-HU (EUCTR) | 07/08/2019 | 04/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Colombia;Argentina;Russian Federation;Romania;Hungary;United States;Japan;United Kingdom;Portugal;Greece;Canada;Austria;Netherlands;Sweden;Turkey;Brazil;Korea, Republic of;Italy;Israel;Slovenia;Australia;Chile;France;Germany | ||
| 22 | EUCTR2018-004476-35-GR (EUCTR) | 07/08/2019 | 19/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren 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: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 23 | EUCTR2013-004808-19-DE (EUCTR) | 05/02/2016 | 07/12/2015 | Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533 | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's | primary Sjögren’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: CFZ533 INN or Proposed INN: Not yet established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | United States;Hungary;Germany;United Kingdom;Switzerland | ||
| 24 | NCT02291029 (ClinicalTrials.gov) | October 22, 2014 | 4/11/2014 | Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CFZ533 in Patients With Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: CFZ533 active - Cohort 1;Drug: CFZ533 placebo- Cohort 1;Drug: CFZ533 active - Cohort 2;Drug: CFZ533 placebo - Cohort 2;Drug: CFZ533 active -Cohort 3;Drug: CFZ533 active - Cohort 3 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 69 | Phase 2 | United States;Germany;Hungary;Switzerland;United Kingdom |
| 25 | EUCTR2013-004808-19-GB (EUCTR) | 23/07/2014 | 07/03/2014 | Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533 | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's | primary Sjögren’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: CFZ533 INN or Proposed INN: Not yet established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Germany;Switzerland;United Kingdom | ||
| 26 | EUCTR2013-004808-19-HU (EUCTR) | 02/07/2014 | 06/05/2014 | Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533 | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's | primary Sjögren’s syndrome MedDRA version: 18.1;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: CFZ533 INN or Proposed INN: Not yet established Product Code: CFZ533 INN or Proposed INN: Not yet established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Hungary;Germany;United Kingdom;Switzerland |